25272 Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules

DEPARTMENT OF HEALTH AND must be submitted to the referenced Pat Brooks, (410) 786–5318, for medical HUMAN SERVICES address to be considered. All comments diagnosis, procedure, and clinical should be incorporated in the e-mail code sets. Office of the Secretary message because we may not be able to Joy Glass, (410) 786–6125, for the access attachments. Electronically following transactions: Health claims 45 CFR Part 142 submitted comments will be available or equivalent encounter information; [HCFA±0149±P] for public inspection at the health care payment and remittance Independence Avenue address below. advice; coordination of benefits; and RIN 0938±AI58 Because of staffing and resource health care claim status. Marilyn Abramovitz, (410) 786–5939, Health Insurance Reform: Standards limitations, we cannot accept comments for the following transactions: for Electronic Transactions by facsimile (FAX) transmission. In commenting, please refer to file code Enrollment and disenrollment in a AGENCY: Health Care Financing HCFA–0149–P and the specific section health plan; eligibility for a health Administration (HCFA), HHS. of this proposed rule. Comments plan; health plan premium payments; ACTION: Proposed rule. received timely will be available for and referral certification and public inspection as they are received, authorization. SUMMARY: This rule proposes standards generally beginning approximately 3 SUPPLEMENTARY INFORMATION: for eight electronic transactions and for weeks after publication of a document, code sets to be used in those in Room 309–G of the Department’s I. Background transactions. It also proposes offices at 200 Independence Avenue, [Please label written or e-mailed comments requirements concerning the use of SW., Washington, DC, on Monday about this section with the subject: these standards by health plans, health through Friday of each week from 8:30 Background] care clearinghouses, and health care a.m. to 5 p.m. (phone: (202) 690–7890). Electronic data interchange (EDI) is providers. Electronic and legible written comments the electronic transfer of information, The use of these standard transactions will also be posted, along with this such as electronic media health care and code sets would improve the proposed rule, at the following web site: claims, in a standard format between Medicare and Medicaid programs and http://aspe.os.dhhs.gov/admnsimp. trading partners. EDI allows entities other Federal health programs and Copies: To order copies of the Federal within the health care system to private health programs, and the Register containing this document, send exchange medical, billing, and other effectiveness and efficiency of the your request to: New Orders, information and process transactions in health care industry in general, by Superintendent of Documents, P.O. Box a manner which is fast and cost simplifying the administration of the 371954, Pittsburgh, PA 15250–7954. effective. With EDI there is a substantial system and enabling the efficient Specify the date of the issue requested reduction in handling and process time, electronic transmission of certain health and enclose a check or money order and the risk of lost paper documents is information. It would implement some payable to the Superintendent of eliminated. EDI can eliminate the of the requirements of Administrative Documents, or enclose your Visa or inefficiencies of handling paper Simplification subtitle of the Health Master Card number and expiration documents, which will significantly Insurance Portability and date. Credit card orders can also be reduce the administrative burden, lower Accountability Act of 1996. placed by calling the order desk at (202) operating costs and improve overall data DATES: Comments will be considered if 512–1800 or by faxing to (202) 512– quality. we receive them at the appropriate 2250. The cost for each copy is $8. As The health care industry recognizes address, as provided below, no later an alternative, you can view and the benefits of EDI and many entities in than 5 p.m. on July 6, 1998. photocopy the Federal Register that industry have developed ADDRESSES: Mail written comments (1 document at most libraries designated proprietary EDI formats. Currently, there original and 3 copies) to the following as Federal Depository Libraries and at are about 400 formats for electronic address: many other public and academic health care claims being used in the libraries throughout the country that Health Care Financing Administration, United States. The lack of receive the Federal Register. standardization makes it difficult to U.S. Department of Health and This Federal Register document is Human Services, Attention: HCFA– develop software, and the efficiencies also available from the Federal Register and savings for health care providers 0149–P, P.O. Box 31850, Baltimore, online database through GPO Access, a MD 21207–8850. and health plans that could be realized service of the U.S. Government Printing if formats were standardized are If you prefer, you may deliver your Office. Free public access is available on diminished. written comments (1 original and 3 a Wide Area Information Server (WAIS) Adopting national standard EDI copies) to one of the following through the Internet and via formats for health care transactions addresses: asynchronous dial-in. Internet users can would greatly decrease the burden on Room 309–G, Hubert H. Humphrey access the database by using the World health care providers and their billing Building, 200 Independence Avenue, Wide Web; the Superintendent of services, as would standardized data SW., Washington, DC 20201, Documents home page address is content. Standard EDI format allows or http://www.access.gpo.gov/suldocs/, data interchange using a common Room C5–09–26, 7500 Security by using local WAIS client software, or interchange structure, thus eliminating Boulevard, Baltimore, MD 21244– by telnet to swais.access.gpo.gov, then the need for users to reprogram their 1850. login as guest (no password required). data processing systems for multiple Comments may also be submitted Dial-in users should use formats. Standardization of the data electronically to the following e-mail communications software and modem content within the interchange structure address: [email protected]. E- to call 202–512–1661; type swais, then involves: (1) Uniform definitions of the mail comments should include the full login as guest (no password required). data elements that will be exchanged in name and address of the sender and FOR FURTHER INFORMATION CONTACT: each type of electronic transaction, and Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules 25273

(2) for some data elements, This section also contains establish standards for code sets for identification of the specific codes or requirements concerning standard each data element for each health care values that are valid for each data setting. transaction listed above, security element. The code sets needed for EDI • The Secretary may adopt a standard standards for health care information in the health care industry include large developed, adopted, or modified by a systems, standards for electronic coding and classification systems for standard setting organization (that is, an signatures (established together with the medical diagnoses, procedures, and organization accredited by the American Secretary of Commerce), and standards drugs, as well as smaller sets of codes National Standards Institute (ANSI)) for the transmission of data elements for such items as types of facility, types that has consulted with the National needed for the coordination of benefits of currency, types of units, and Uniform Billing Committee (NUBC), the and sequential processing of claims. specified State within the United States. National Uniform Claim Committee Compliance with electronic signature Standardized data content is essential to (NUCC), the Workgroup for Electronic standards will be deemed to satisfy both accurate and efficient EDI between the Data Interchange (WEDI), and the State and Federal requirements for many producers and users of American Dental Association (ADA). written signatures with respect to the administrative health data transactions. • The Secretary may also adopt a transactions listed in paragraph (a) of standard other than one established by section 1173 of the Act. A. Legislation a standard setting organization, if the In section 1174 of the Act, the The Congress included provisions to different standard will reduce costs for Secretary is required to adopt standards address the need for electronic health care providers and health plans, for all of the above transactions, except transactions and other administrative the different standard is promulgated claims attachments, within 24 months simplification issues in the Health through negotiated rulemaking after enactment. The standards for Insurance Portability and procedures, and the Secretary consults claims attachments must be adopted Accountability Act of 1996 (HIPAA), with each of the above-named groups. within 30 months after enactment. Public Law 104–191, which was enacted • If no standard has been adopted by Generally, after a standard is established on August 21, 1996. Through subtitle F any standard setting organization, the it cannot be changed during the first of title II of that law, the Congress added Secretary is to rely on the year except for changes that are to title XI of the Social Security Act a recommendations of the National necessary to permit compliance with the new part C, entitled ‘‘Administrative Committee on Vital and Health standard. Modifications to any of these Simplification.’’ (Public Law 104–191 Statistics (NCVHS) and consult with the standards may be made after the first affects several titles in the United States above-named groups. year, but not more frequently than once Code. Hereafter, we refer to the Social In complying with the requirements every 12 months. The Secretary must Security Act as the Act; we refer to the of part C of title XI, the Secretary must also ensure that procedures exist for the other laws cited in this document by rely on the recommendations of the routine maintenance, testing, their names.) The purpose of this part is NCVHS, consult with appropriate State, enhancement, and expansion of code to improve the Medicare and Medicaid Federal, and private agencies or sets and that there are crosswalks from programs in particular and the organizations, and publish the prior versions. efficiency and effectiveness of the recommendations of the NCVHS in the Section 1175 of the Act prohibits health care system in general by Federal Register. health plans from refusing to process or encouraging the development of a Paragraph (a) of section 1173 of the delaying the processing of a transaction health information system through the Act requires that the Secretary adopt that is presented in standard format. establishment of standards and standards for financial and The Act’s requirements are not limited requirements to facilitate the electronic administrative transactions, and data to health plans, however; instead, each transmission of certain health elements for those transactions, to person to whom a standard or information. enable health information to be implementation specification applies is Part C of title XI consists of sections exchanged electronically. Standards are required to comply with the standard 1171 through 1179 of the Act. These required for the following transactions: within 24 months (or 36 months for sections define various terms and health claims, health encounter small health plans) of its adoption. A impose several requirements on HHS, information, health claims attachments, plan or person may, of course, comply health plans, health care clearinghouses, health plan enrollments and voluntarily before the effective date. A and certain health care providers disenrollments, health plan eligibility, person may comply by using a health concerning the electronic transmission health care payment and remittance care clearinghouse to transmit or receive of health information. advice, health plan premium payments, the standard transactions. Compliance The first section, section 1171 of the first report of injury, health claim status, with modifications to standards or Act, establishes definitions for purposes and referral certification and implementation specifications must be of part C of title XI for the following authorization. In addition, the Secretary accomplished by a date designated by terms: code set, health care is required to adopt standards for any the Secretary. This date may not be clearinghouse, health care provider, other financial and administrative earlier than 180 days after the notice of health information, health plan, transactions that are determined to be change. individually identifiable health appropriate by the Secretary. Section 1176 of the Act establishes a information, standard, and standard Paragraph (b) of section 1173 of the civil monetary penalty for violation of setting organization. Act requires the Secretary to adopt the provisions in part C of title XI of the Section 1172 of the Act makes any standards for unique health identifiers Act, subject to several limitations. standard adopted under part C for all individuals, employers, health Penalties may not be more than $100 applicable to (1) all health plans, (2) all plans, and health care providers and per person per violation and not more health care clearinghouses, and (3) any requires further that the adopted than $25,000 per person per violation of health care providers that transmit any standards specify for what purposes a single standard for a calendar year. health information in electronic form in unique health identifiers may be used. The procedural provisions in section connection with transactions referred to Paragraphs (c) through (f) of section 1128A of the Act, ‘‘Civil Monetary in section 1173(a)(1) of the Act. 1173 of the Act require the Secretary to Penalties,’’ are applicable. 25274 Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules

Section 1177 of the Act establishes interdepartmental implementation forth in Executive Order 12866 and the penalties for a knowing misuse of teams to identify and assess potential Paperwork Reduction Act of 1995. To be unique health identifiers and standards for adoption. The subject designated as an HIPAA standard, each individually identifiable health matter of the teams includes claims/ standard should: information: (1) A fine of not more than encounters, identifiers, enrollment/ 1. Improve the efficiency and $50,000 and/or imprisonment of not eligibility, systems security, and effectiveness of the health care system more than 1 year; (2) if misuse is ‘‘under medical coding/classification. Another by leading to cost reductions for or false pretenses,’’ a fine of not more than team addresses cross-cutting issues and improvements in benefits from $100,000 and/or imprisonment of not coordinates the subject matter teams. electronic health care transactions. more than 5 years; and (3) if misuse is The teams consult with external groups 2. Meet the needs of the health data with intent to sell, transfer, or use such as the NCVHS’’ Workgroup on standards user community, particularly individually identifiable health Data Standards, WEDI, ANSI’s health care providers, health plans, and information for commercial advantage, Healthcare Informatics Standards Board health care clearinghouses. personal gain, or malicious harm, a fine (HISB), the NUCC, the NUBC, and the 3. Be consistent and uniform with the of not more than $250,000 and/or ADA. The teams are charged with other HIPAA standards—their data imprisonment of not more than 10 developing regulations and other element definitions and codes and their years. necessary documents and making privacy and security requirements— Under section 1178 of the Act, the recommendations for the various and, secondarily, with other private and provisions of part C of title XI of the standards to the HHS’’ Data Council public sector health data standards. Act, as well as any standards through its Committee on Health Data 4. Have low additional development established under them, supersede any Standards. (The HHS Data Council is and implementation costs relative to the State law that is contrary to them. the focal point for consideration of data benefits of using the standard. However, the Secretary may, for policy issues. It reports directly to the 5. Be supported by an ANSI- statutorily specified reasons, waive this Secretary and advises the Secretary on accredited standards developing provision. data standards and privacy issues.) organization or other private or public Finally, section 1179 of the Act makes 2. Develop recommendations for organization that will ensure continuity the above provisions inapplicable to standards to be adopted. and efficient updating of the standard financial institutions or anyone acting 3. Publish proposed rules in the over time. on behalf of a financial institution when Federal Register describing the 6. Have timely development, testing, ‘‘authorizing, processing, clearing, standards. Each proposed rule provides implementation, and updating settling, billing, transferring, the public with a 60-day comment procedures to achieve administrative reconciling, or collecting payments for a period. simplification benefits faster. financial institution’’. 4. Analyze public comments and 7. Be technologically independent of (Concerning this last provision, the publish the final rules in the Federal the computer platforms and conference report, in its discussion on Register. transmission protocols used in section 1178, states: 5. Distribute standards and coordinate electronic health transactions, except when they are explicitly part of the ‘‘The conferees do not intend to exclude preparation and distribution of the activities of financial institutions or their implementation guides. standard. contractors from compliance with the This strategy affords many 8. Be precise and unambiguous, but as standards adopted under this part if such opportunities for involvement of simple as possible. activities would be subject to this part. interested and affected parties in 9. Keep data collection and However, conferees intend that this part does standards development and adoption by paperwork burdens on users as low as not apply to use or disclosure of information enabling them to: is feasible. when an individual utilizes a payment • Participate with standards setting 10. Incorporate flexibility to adapt system to make a payment for, or related to, organizations. more easily to changes in the health care health plan premiums or health care. For • infrastructure (such as new services, example, the exchange of information Provide written input to the between participants in a credit card system NCVHS. organizations, and provider types) and in connection with processing a credit card • Provide written input to the information technology. payment for health care would not be Secretary of the HHS. A master data dictionary providing for covered by this part. Similarly sending a • Provide testimony at NCVHS’ common data definitions across the checking account statement to an account public meetings. standards selected for implementation holder who uses a credit or debit card to pay • Comment on the proposed rules for under HIPAA will be developed and for health care services, would not be each of the proposed standards. maintained. We intend for the data covered by this part. However, this part does • Invite HHS staff to meetings with apply if a company clears health care claims, element definitions to be precise, the health care claims activities remain public and private sector organizations unambiguous, and consistently applied. subject to the requirements of this part.’’) or meet directly with senior HHS staff The transaction-specific reports and (H.R. Rep. No. 736, 104th Cong., 2nd Sess. involved in the implementation process. general reports from the master data 268–269 (1996)) The implementation teams charged dictionary will be readily available to with reviewing standards for the public. At a minimum, the B. Process for Developing National designation as required national information presented will include data Standards standards under the statute have element names, definitions, and The Secretary has formulated a 5-part defined, with significant input from the appropriate references to the strategy for developing and health care industry, a set of principles transactions where they are used. implementing the standards mandated for guiding choices for the standards to under part C of title XI of the Act: be adopted by the Secretary. These C. ANSI-Accredited Standards 1. To ensure necessary interagency principles are based on direct Committee Standard Setting Process coordination and required interaction specifications in HIPAA and the ANSI chartered the X12 Accredited with other Federal departments and the purpose of the law, principles that Standards Committee (ASC) a number of private sector, establish support the regulatory philosophy set years ago to design national electronic Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules 25275 standards for a wide range of business Members of the ASC X12 committee Large coding and classification systems applications. A separate ASC X12N are eligible to vote on ASC X12N issues. for medical data elements (for example, Subcommittee was in turn chartered to ASC X12N votes technical issues by diagnoses, procedures, and drugs), and develop electronic standards specific to letter ballot. Administrative issues may (2) smaller sets of codes for data the insurance industry, including health be voted by letter ballot or at general elements such as type of facility, type of care insurance. Volunteer members of sessions during ASC X12N meetings. units, and specified State within the ASC X12N Subcommittee, including The NCPDP Telecommunication address fields. Federal agencies (NCHS, health care providers, health plans, Standard 3.2 specifies the rules HCFA, FDA) and some private bankers, and vendors involved in regarding the creation of a new version organizations (the AMA and the ADA) software development/billing/ and release. The NCPDP standards have developed and maintained transmission of health care data and development process involves additions standards for large medical data code other business aspects of health care of new data elements or additional sets. In the past, these code sets have administrative activities, worked to values to existing data elements. been mandated for use in some Federal Updated documentation of existing or develop standards for electronic health and State programs, such as Medicare new data elements and a new version is care transactions. ANSI accredits and Medicaid, and the ASC X12N and created with changes to: (1) The standards setting organizations to NCPDP standards setting organizations definition of an existing data element, ensure that the procedures used meet have adopted these code sets for use in certain due process requirements and (2) deletions of values of an existing data element, (3) deletions of existing their standards. For the smaller sets of that the process is voluntary, open, and codes needed for various transaction based on obtaining consensus. Both data elements, (4) major structural changes to the formats, (5) changes in data elements they have designated Accredited Standards Committee (ASC) other de facto standards, such as the 2- X12 and the National Council for the size of data elements, or (6) changes in the formats of data elements. character state abbreviations used by the Prescription Drug Programs (NCPDP) are U.S. Postal Service, or developed code ANSI-accredited standards developers. These rules were confirmed by the Board of Trustees in June, 1995 and sets specifically for their transaction Each of the two standards setting ensure that the health plan explicitly standards. organizations has written procedures for knows which Data Dictionary to apply the establishment of, and revisions to, This proposed rule would establish to the transaction when processing the established standards. All of the X12 the standards for code sets to be used in claim. Likewise, the pharmacy needs to Subcommittee N: Insurance (to which seven of the transactions specified in know what are the acceptable fields in we refer hereafter as X12N) standard section 1173(a)(2) of the Act, and for a the response returned from the health implementations mentioned in this transaction for coordination of benefits. plan. regulation are ASC X12 standards and We anticipate publishing several In addition, the Telecommunication regulations documents altogether to are published under the designation Standard Format Version/Release ‘‘Draft Standard for Trial Use (DSTU)’’. promulgate the various standards changes anytime there is an approved required under the HIPAA. The other These standards are fully accepted and change to the Professional Pharmacy proposed regulations cover security published national standards for use in Services (PPS) standard, Drug standards, the seventh and ninth electronic data exchanges. The DSTU Utilization Review (DUR) standard, transactions specified in the Act (first designation is used to distinguish ASC Billing Unit standard or to the data report of injury and claims X12 standards from those standards that elements for the claim itself. have been forwarded to the American All NCPDP implementation guides attachments), and the four identifiers. National Standards Institute for must be reviewed and approved by the II. Provisions of the Proposed acceptance as American National Maintenance and Control Work Group Regulations Standards. ASC X12 creates a family of prior to release to the membership. All standards that are related and therefore proposed standards will have an [Please label written comments or e-mailed only forwards standards to ANSI every implementation guide developed and comments about this section with the subject: five years. Although the official approved prior to the proposed standard Provisions] designation of X12 standards includes being balloted. Once balloted, the In this proposed rule, we propose the word ‘‘Draft’’, these standards are originating committee may work with final, published national standards. standards for eight transactions and for individual disapproval votes to code sets to be used in the transactions. The ASC X12 development process accommodate their concerns and involves negotiation and consensus We also propose requirements convert their votes to approval. If the concerning the implementation of these building, resulting in approval and changes made to accommodate publication of DSTU and American standards. This proposed rule would set disapproval votes are considered forth requirements that health plans, National Standards. The ASC X12 substantial, then the item under committee maintains current standards, health care clearinghouses, and certain consideration must be balloted again. health care providers would have to proposes new standards and embraces After the originating group has meet concerning the use of these new ideas. reviewed all comments received during standards. The ASC X12N Subcommittee is the the letter ballot period, the Co-Chairs of decision-making body responsible for the originating group make a written We propose to add a new part to title obtaining consensus, which is necessary request to the Board of Trustees for the 45 of the Code of Federal Regulations for approval of American National ballot results collected from the for health plans, health care providers, Standards in the field of insurance. The Standardization Co-chairs and the Board and health care clearinghouses in ASC X12N Subcommittee has the of Directors. The Board of Trustees general. The new part would be part 142 responsibility for specific standards retains final authority over the of title 45 and would be titled development and standards certification of these ballot results. ‘‘Administrative Requirements.’’ maintenance activities, but its work Two types of code sets are required Subparts J through R would contain the must be ratified by the membership of for data elements in ASC X12N and provisions specifically concerning the ASC X12 as a whole. NCPDP health transaction standards: (1) standards proposed in this rule. 25276 Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules

A. Applicability transportation, physical alterations to company would not have to use the Section 262 of HIPAA applies to all living quarters for the purpose of standards to pass encounter information health plans, all health care accommodating disabilities, and case back to the home office, but it would clearinghouses, and any health care management. Other services may be have to use the standard claims providers that transmit any health added to this list at the discretion of the transaction to submit a claim to another information in electronic form in Secretary. health plan. Another example might be connection with transactions referred to We invite comments on this list and transactions within Federal agencies in section 1173(a)(1) of the Act. Our ask for identification of other types of and their contractors and between State proposed rules (at 45 CFR 142.102) services that may fall into this category. agencies within the same State. For would apply to the health plans and We will publish a complete list of these example, Medicare enters into contracts health care clearinghouses as well, but services and a process to request an with insurance companies and common we would clarify the statutory language exemption in the final rule. working file sites that process Medicare The law applies to health plans for all in our regulations for health care claims using government furnished transactions. software. There is constant providers: we would have the Section 142.104 would contain the regulations apply to any health care communication, on a private network, following provisions (from section 1175 between HCFA Central Office and the provider only when electronically of the Act): transmitting any of the transactions to Medicare carriers, intermediaries and If a person conducts a transaction (as common working file sites. This which section 1173(a)(1) of the Act defined in § 142.103) with a health plan refers. communication may continue in as a standard transaction, the following nonstandard mode. However, these Electronic transmissions would apply: include transmissions using all media, contractors must comply with the (1) The health plan may not refuse to standards when exchanging any of the even when the transmission is conduct the transaction as a standard physically moved from one location to transactions covered by HIPAA with an transaction. entity outside these ‘‘corporate’’ another using magnetic tape, disk, or CD (2) The health plan may not delay the media. Transmissions over the Internet boundaries. transaction or otherwise adversely Although there are situations in (wide-open), Extranet (using Internet affect, or attempt to adversely affect, the technology to link a business with which the use of the standards is not person or the transaction on the ground required (for example, health care information only accessible to that the transaction is a standard collaborating parties), leased lines, dial- providers may continue to submit paper transaction. claims and employers are not required up lines, and private networks are all (3) The information transmitted and included. Telephone voice response and to use any of the standard transactions), received in connection with the we stress that a standard may be used ‘‘faxback’’ systems would not be transaction must be in the form of included. voluntarily in any situation in which it standard data elements of health is not required. Our regulations would apply to health information. care clearinghouses when transmitting As a further requirement, we would B. Definitions transactions to, and receiving provide that a health plan that conducts Section 1171 of the Act defines transactions from, any health care transactions through an agent assure several terms and our proposed rules provider or health plan that transmits that the agent meets all the requirements would, for the most part, simply restate and receives standard transactions (as of part 142 that apply to the health plan. the law. The terms that we are defining defined under ‘‘transaction’’) and at all Section 142.105 would state that a in this proposed rule follow: times when transmitting to or receiving person or other entity may meet the 1. ASC X12 stands for the Accredited transactions from another health care requirements of § 142.104 by either— Standards Committee chartered by the clearinghouse. (1) Transmitting and receiving American National Standards Institute Entities that offer on-line interactive standard data elements, or to design national electronic standards transmission must comply with the (2) Submitting nonstandard data for a wide range of business standards. The HyperText Markup elements to a health care clearinghouse applications. Language (HTML) interaction between a for processing into standard data 2. ASC X12N stands for the ASC X12 server and a browser by which the data elements and transmission by the health subcommittee chartered to develop elements of a transaction are solicited care clearinghouse and receiving electronic standards specific to the from a user would not have to use the standard data elements through the insurance industry. standards, although the data content health care clearinghouse. 3. Code set. must be equal to that required for the Health care clearinghouses would be We would define ‘‘code set’’ as standard. Once the data elements are able to accept nonstandard transactions section 1171(1) of the Act does: ‘‘code assembled into a transaction by the for the sole purpose of translating them set’’ means any set of codes used for server, the transmitted transaction into standard transactions for sending encoding data elements, such as tables would have to comply with the customers and would be able to accept of terms, medical concepts, medical standards. standard transactions and translate them diagnosis codes, or medical procedure The law would apply to each health into nonstandard formats for receiving codes. care provider when transmitting or customers. We would state in § 142.105 4. Health care clearinghouse. receiving any of the specified electronic that the transmission of nonstandard We would define ‘‘health care transactions. Transactions for certain transactions, under contract, between a clearinghouse’’ as section 1171(2) of the services that are not normally health plan or a health care provider Act does, but we are adding a further, considered health care services, but and a health care clearinghouse would clarifying sentence. The statute defines which may be covered by some health not violate the law. a ‘‘health care clearinghouse’’ as a plans, would not be subject to the Transmissions within a corporate public or private entity that processes or standards proposed in this rule. These entity would not be required to comply facilitates the processing of nonstandard services would include, but not be with the standards. A hospital that is data elements of health information into limited to: nonemergency wholly owned by a managed care standard data elements. We would Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules 25277 further explain that such an entity is U.S.C. 300gg–91); we would incorporate section 3(1) of ERISA) to the extent that one that currently receives health care those definitions as currently stated into the plan provides medical care, transactions from health care providers our proposed definitions for the including items and services paid for as and other entities, translates the data convenience of the public. We note that medical care, to employees or their from a given format into one acceptable many of these terms are defined in other dependents directly or through to the intended recipient, and forwards statutes, such as the Employee insurance, or otherwise. the processed transaction to appropriate Retirement Income Security Act of 1974 It should be noted that group health health plans and other health care (ERISA), Public Law 93–406, 29 U.S.C. plans that have fewer than 50 clearinghouses, as necessary, for further 1002(7) and the Public Health Service participants and that are administered action. Act. Our definitions are based on the by the employer would be excluded There are currently a number of roles of plans in conducting from this definition and would not be private clearinghouses that perform administrative transactions, and any subject to the administrative these functions for health care differences should not be construed to simplification provisions of HIPAA. providers. For purposes of this rule, we affect other statutes. b. ‘‘Health insurance issuer’’ (as would consider billing services, For purposes of implementing the currently defined by section 2791(b) of repricing companies, community health provisions of administrative the Public Health Service Act). management information systems or simplification, a ‘‘health plan’’ would be Section 2791(b)(2) of the Public community health information systems, an individual or group health plan that Health Service Act currently defines a value-added networks, and switches provides, or pays the cost of, medical ‘‘health insurance issuer’’ as an performing these functions to be health care. This definition includes, but is not insurance company, insurance service, care clearinghouses. limited to, the 13 types of plans listed or insurance organization that is 5. Health care provider. in the statute. On the other hand, plans licensed to engage in the business of As defined by section 1171(3) of the such as property and casualty insurance insurance in a State and is subject to Act, a ‘‘health care provider’’ is a plans and workers compensation plans, State law that regulates insurance. provider of services as defined in which may pay health care costs in the c. ‘‘Health maintenance organization’’ section 1861(u) of the Act, a provider of course of administering nonhealth care (as currently defined by section 2791(b) medical or other health services as benefits, are not considered to be health of the Public Health Service Act). defined in section 1861(s) of the Act, plans in the proposed definition of Section 2791(b) of the Public Health and any other person who furnishes health plan. Of course, these plans may Service Act currently defines a ‘‘health health care services or supplies. Our voluntarily adopt these standards for maintenance organization’’ as a regulations would define ‘‘health care their own business needs. At some Federally qualified health maintenance provider’’ as the statute does and clarify future time, the Congress may choose to organization, an organization recognized that the definition of a health care expressly include some or all of these as such under State law, or a similar provider is limited to those entities that plans in the list of health plans that organization regulated for solvency furnish, or bill and are paid for, health must comply with the standards. under State law in the same manner and care services in the normal course of Health plans often carry out their to the same extent as such a health business. business functions through agents, such maintenance organization. These For a more detailed discussion of the as plan administrators (including third organizations may include preferred definition of health care provider, we party administrators), entities that are provider organizations, provider refer the reader to our proposed rule, under ‘‘administrative services only’’ sponsored organizations, independent HCFA–0045-P, Standard Health Care (ASO) contracts, claims processors, and practice associations, competitive Provider Identifier, published elsewhere fiscal agents. These agents may or may medical plans, exclusive provider in this Federal Register. not be health plans in their own right; organizations, and foundations for 6. Health information. for example, a health plan may act as medical care. ‘‘Health information,’’ as defined in another health plan’s agent as another d. Part A or Part B of the Medicare section 1171 of the Act, means any line of business. As stated earlier, a program (title XVIII of the Act). information, whether oral or recorded in health plan that conducts HIPAA e. The Medicaid program (title XIX of any form or medium, that— transactions through an agent is the Act). • Is created or received by a health required to assure that the agent meets f. A ‘‘Medicare supplemental policy’’ care provider, health plan, public health all HIPAA requirements that apply to as defined under section 1882(g)(1) of authority, employer, life insurer, school the plan itself. the Act. or university, or health care ‘‘Health plan’’ includes the following, Section 1882(g)(1) of the Act defines clearinghouse; and singly or in combination: a ‘‘Medicare supplemental policy’’ as a • Relates to the past, present, or a. ‘‘Group health plan’’ (as currently health insurance policy that a private future physical or mental health or defined by section 2791(a) of the Public entity offers a Medicare beneficiary to condition of an individual, the Health Service Act). A group health provide payment for expenses incurred provision of health care to an plan is a plan that has 50 or more for services and items that are not individual, or the past, present, or participants (as the term ‘‘participant’’ is reimbursed by Medicare because of future payment for the provision of currently defined by section 3(7) of deductible, coinsurance, or other health care to an individual. ERISA) or is administered by an entity limitations under Medicare. The We propose the same definition for other than the employer that established statutory definition of a Medicare our regulations. and maintains the plan. This definition supplemental policy excludes a number 7. Health plan. includes both insured and self-insured of plans that are generally considered to We propose that a ‘‘health plan’’ be plans. We define ‘‘participant’’ be Medicare supplemental plans, such defined essentially as section 1171 of separately below. as health plans for employees and the Act defines it. Section 1171 of the Section 2791(a)(1) of the Public former employees and for members and Act cross refers to definitions in section Health Service Act defines ‘‘group former members of trade associations 2791 of the Public Health Service Act health plan’’ as an employee welfare and unions. A number of these health (as added by Public Law 104–191, 42 benefit plan (as currently defined in plans may be included under the 25278 Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules definitions of ‘‘group health plan’’ or Note: Although section 1171(5)(M) of the 10. Small health plan. ‘‘health insurance issuer’’, as defined in Act refers to the ‘‘Federal Employees Health We would define a ‘‘small health a. and b. above. Benefit Plan,’’ this and any other rules plan’’ as a group health plan with fewer g. A ‘‘long-term care policy,’’ adopting administrative simplification than 50 participants. including a nursing home fixed- standards will use the correct name, the The HIPAA does not define a ‘‘small Federal Employees Health Benefits Program. indemnity policy. A ‘‘long-term care One health plan does not cover all Federal health plan’’ but instead leaves the policy’’ is considered to be a health plan employees; there are over 350 health plans definition to be determined by the regardless of how comprehensive it is. that provide health benefits coverage to Secretary. The Conference Report We recognize the long-term care Federal employees, retirees, and their eligible suggests that the appropriate definition insurance segment of the industry is family members. Therefore, we will use the of a ‘‘small health plan’’ is found in largely unautomated and we welcome correct name, the Federal Employees Health current section 2791(a) of the Public comments regarding the impact of Benefits Program, to make clear that the Health Service Act, which is a group HIPAA on the long-term care segment. administrative simplification standards apply health plan with fewer than 50 h. An employee welfare benefit plan to all health plans that participate in the Program. participants. We would also define or any other arrangement that is small individual health plans as those established or maintained for the n. Any other individual or group with fewer than 50 participants. purpose of offering or providing health health plan, or combination thereof, that 11. Standard. benefits to the employees of two or more provides or pays for the cost of medical Section 1171 of the Act defines employers. This includes plans and care. ‘‘standard,’’ when used with reference other arrangements that are referred to We would include a fourteenth to a data element of health information as multiple employer welfare category of health plan in addition to or a transaction referred to in section arrangements (‘‘MEWAs’’) as defined in those specifically named in HIPAA, as 1173(a)(1) of the Act, as any such data section 3(40) of ERISA. there are health plans that do not element or transaction that meets each i. The health care program for active readily fit into the other categories but of the standards and implementation military personnel under title 10 of the whose major purpose is providing specifications adopted or established by United States Code. health benefits. The Secretary would the Secretary with respect to the data j. The veterans health care program determine which of these plans are element or transaction under sections under chapter 17 of title 38 of the health plans for purposes of title II of 1172 through 1174 of the Act. United States Code. HIPAA. This category would include Under our definition, a standard This health plan primarily furnishes the Medicare Plus Choice plans that will would be a set of rules for a set of codes, medical care through hospitals and become available as a result of section data elements, transactions, or clinics administered by the Department 1855 of the Act as amended by section identifiers promulgated either by an of Veterans Affairs for veterans with a 4001 of the Balanced Budget Act of 1997 organization accredited by ANSI or the service-connected disability that is (Pub. L. 105–33) to the extent that these HHS for the electronic transmission of compensable. Veterans with non- health plans do not fall under any other health information. service-connected disabilities (and no category. 12. Transaction. other health benefit plan) may receive 8. Medical care. ‘‘Transaction’’ would mean the health care under this health plan to the ‘‘Medical care,’’ which is used in the exchange of information between two extent resources and facilities are definition of health plan, would be parties to carry out financial and available. defined as current section 2791 of the administrative activities related to k. The Civilian Health and Medical Public Health Service Act defines it: the health care. A transaction would be (a) Program of the Uniformed Services diagnosis, cure, mitigation, treatment, or any of the transactions listed in section (CHAMPUS), as defined in 10 U.S.C. prevention of disease, or amounts paid 1173(a)(2) of the Act and (b) any 1072(4). for the purpose of affecting any body determined appropriate by the Secretary CHAMPUS primarily covers services structure or function of the body; in accordance with section 1173(a)(1)(B) furnished by civilian medical providers amounts paid for transportation of the Act. We present them below in to dependents of active duty members of primarily for and essential to these the order in which we propose the uniformed services and retirees and items; and amounts paid for insurance standards for them in the regulations their dependents under age 65. covering the items and the text. l. The Indian Health Service program transportation specified in this A ‘‘transaction’’ would mean any of under the Indian Health Care definition. the following: Improvement Act (25 U.S.C. 1601 et 9. Participant. a. Health claims or equivalent seq.). We would define the term encounter information. This program furnishes services, ‘‘participant’’ as section 3(7) of ERISA This transaction may be used to generally through its own health care currently defines it: a ‘‘participant’’ is submit health care claim billing providers, primarily to persons who are any employee or former employee of an information, encounter information, or eligible to receive services because they employer, or any member or former both, from health care providers to are of American Indian or Alaskan member of an employee organization, health plans, either directly or via Native descent. who is or may become eligible to receive intermediary billers and claims m. The Federal Employees Health a benefit of any type from an employee clearinghouses. Benefits Program under 5 U.S.C. chapter benefit plan that covers employees of b. Health care payment and 89. such an employer or members of such remittance advice. This program consists of health organizations, or whose beneficiaries This transaction may be used by a insurance plans offered to active and may be eligible to receive any such health plan to make a payment to a retired Federal employees and their benefits. An ‘‘employee’’ would include financial institution for a health care dependents. Depending on the health an individual who is treated as an provider (sending payment only), to plan, the services may be furnished on employee under section 401(c)(1) of the send an explanation of benefits or a a fee-for-service basis or through a Internal Revenue Code of 1986 (26 remittance advice directly to a health health maintenance organization. U.S.C. 401(c)(1)). care provider (sending data only), or to Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules 25279 make payment and send an explanation dependent under the subscriber’s C. Effective Dates—General of benefits remittance advice to a health policy. It also can be used to Health plans would be required by care provider via a financial institution communicate information about or Part 142 to comply with our (sending both payment and data). changes to eligibility, coverage, or requirements as follows: c. Coordination of benefits. benefits from information sources (such 1. Each health plan that is not a small This transaction can be used to as insurers, sponsors, and health plans) health plan would have to comply with transmit health care claims and billing to information receivers (such as the requirements of Part 142 no later payment information between health physicians, hospitals, third party plans with different payment than 24 months after the effective date administrators, and government of the final rule. responsibilities where coordination of agencies). benefits is required or between health 2. Each small health plan would have g. Health plan premium payments. plans and regulatory agencies to to comply with the requirements of Part monitor the rendering, billing, and/or This transaction may be used by, for 142 no later than 36 months after the payment of health care services within example, employers, employees, unions, effective date of the final rule. Health care providers and health care a specific health care/insurance and associations to make and keep track clearinghouses would be required to industry segment. of payments of health plan premiums to In addition to the nine electronic their health insurers. begin using the standard by 24 months transactions specified in section h. Referral certification and after the effective date of the final rule. 1173(a)(2) of the Act, section 1173(f) authorization. (The effective date of the final rule will be 60 days after the final rule is directs the Secretary to adopt standards This transaction may be used to for transferring standard data elements published in the Federal Register.) transmit health care service referral Provisions of trading partner among health plans for coordination of information between health care benefits and sequential processing of agreements that stipulate data content, providers, health care providers format definitions or conditions that claims. This particular provision does furnishing services, and health plans. It not state that there should be standards conflict with the adopted standard can also be used to obtain authorization would be invalid beginning 36 months for electronic transfer of standard data for certain health care services from a elements among health plans. However, from the effective date of the final rule health plan. for small health plans, and 24 months we believe that the Congress, when i. First report of injury. writing this provision, intended for from the effective date of the final rule these standards to apply to the This transaction may be used to report for all other health plans. electronic form for coordination of information pertaining to an injury, If HHS adopts a modification to an benefits and sequential processing of illness, or incident to entities interested implementation specification or a claims. The Congress expressed its in the information for statistical, legal, standard, the implementation date of intent on these matters generally in claims, and risk management processing the modification would be no earlier section 1173(a)(1)(B), where the requirements. Although we are than the 180th day following the Secretary is directed to adopt ‘‘other proposing a definition for this adoption of the modification. HHS financial and administrative transaction, we are not proposing a would determine the actual date, taking transactions * * * consistent with the standard for it in this Federal Register into account the time needed to comply goals of improving the operation of the document. (See section E.9 for a more due to the nature and extent of the health care system and reducing in-depth discussion.) We will publish a modification. HHS would be able to administrative costs.’’ separate proposed rule for it. extend the time for compliance for small d. Health claim status. j. Health claims attachments. health plans. This provision would be at § 142.106. This transaction may be used by This transaction may be used to The law does not address scheduling health care providers and recipients of transmit health care service information, of implementation of the standards; it health care products or services (or their such as subscriber, patient, gives only a date by which all authorized agents) to request the status demographic, diagnosis, or treatment concerned must comply. As a result, of a health care claim or encounter from data for the purpose of a request for any of the health plans, health care a health plan. review, certification, notification, or clearinghouses, and health care e. Enrollment and disenrollment in a reporting the outcome of a health care providers may implement a given health plan. services review. Although we are standard earlier than the date specified This transaction may be used to proposing a definition for this in the subpart created for that standard. establish communication between the transaction, we are not proposing a We realize that this may create some sponsor of a health benefit and the standard for it in this Federal Register problems temporarily, as early health plan. It provides enrollment data, document because the legislation gave implementers would have to be able to such as subscriber and dependents, the Secretary an additional year to continue using old standards until the employer information, and health care designate this standard. We will publish new ones must, by law, be in place. provider information. The sponsor is the a separate proposed rule for it. backer of the coverage, benefit or At the WEDI Healthcare Leadership product. A sponsor can be an employer, k. Other transactions as the Secretary Summit held on August 15, 1997, it was union, government agency, association, may prescribe by regulation. recommended that health care providers or insurance company. The health plan Under section 1173(a)(1)(B) of the not be required to use any of the refers to an entity that pays claims, Act, the Secretary shall adopt standards, standards during the first year after the administers the insurance product or and data elements for those standards, adoption of the standard. However, benefit, or both. for other financial and administrative willing trading partners could f. Eligibility for a health plan. transactions deemed appropriate by the implement any or all of the standards by This transaction may be used to Secretary. These transactions would be mutual agreement at any time during inquire about the eligibility, coverage, or consistent with the goals of improving the 2-year implementation phase (3-year benefits associated with a benefit plan, the operation of the health care system implementation phase for small health employer, plan sponsor, subscriber, or a and reducing administrative costs. plans). In addition, it was recommended 25280 Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules that a health plan give its health care of the data possible—based on the standards are part of the transaction providers at least 6 months notice before appropriate implementation guide, data standards themselves and are specified requiring them to use a given standard. content and data conditions in their implementation guides. We welcome comments specifically specifications, and data dictionary— The following medical data code sets on early implementation as to the extent then a health plan would have to accept are already in use in administrative and to which it would cause problems and the transaction and process it. This does financial transactions: how any problems might be alleviated. not mean, however, that the health plan ICD–9–CM: The International Classification of Diseases, Ninth D. Data Content would have to store or use information that it does not need in order to process Revision, Clinical Modification, [Please label any written comments or e- a claim or encounter, except for audit classifies both diagnoses (Volumes 1 mailed comments about this section with the trail purposes or for coordination of and 2) and procedures (Volume 3). All subject: Data Content] benefits if applicable. It does mean that hospitals and ambulatory care settings We propose standard data content for the health plan would not be able to use it to capture diagnoses for each adopted standard. There are two require additional information, and it administrative transactions. The aspects of data content standardization: does mean that the health plan would procedure system is used for all in- (1) Standardization of data elements, not be able to reject a transaction patient procedure coding for including their formats and definition, because it contains information the administrative transactions. The ICD–9– and (2) standardization of the code sets health plan does not want. This CM was adopted for use in January or values that can appear in selected principle applies to the data elements of 1979. data elements. A telephone number is all transactions proposed for adoption The ICD–9–CM Coordination and an example of a data element that has in this proposed rule. Maintenance Committee is a Federal a standard definition and format, but interdepartmental committee charged does not have an enumerated set of 2. Code Sets with maintaining and updating the ICD– valid codes or values. A patient’s [Please label any written comments or e- 9–CM. Requests for modification are diagnosis is an example of a data mailed comments about this section with the handled through the ICD–9–CM element that has a standard definition, subject: Code Sets] Coordination and Maintenance a standard format, and a set of valid Committee; no official changes are made a. Background codes. Information that would facilitate without being brought before this data content standardization, while also The administrative simplification committee. Suggestions for facilitating identical implementations, provisions of HIPAA require the modifications come from both the would consist of implementation Secretary of HHS to adopt standards for public and private sectors and guides, data conditions, and data code sets for administrative and interested parties are asked to submit dictionaries, as noted in the addenda to financial transactions. Two types of recommendations for modification prior this proposed rule, and the standard code sets are required for data elements to a scheduled meeting. code sets for medical data that are part in the transaction standards to be Modifications are not considered of this rule. Data conditions are rules established under HIPAA: (1) Large without the expert advice of clinicians, that define the situations when a code sets for medical data, including epidemiologists, and nosologists (both particular data element or record/ coding systems for: public and private sectors). The segment can be used. For example, ‘‘the • Diseases, injuries, impairments, meetings are open to the public and are name of the tribe’’ applies only to other health related problems, and their announced in the Federal Register; all Indian Health Service claims. The manifestations; interested members of the public are defining rule for that data element • Causes of injury, disease, invited to attend and submit written would be ‘‘must be entered if claim is impairment, or other health-related comments. Meetings are held twice each Indian Health Service’’. problems; year. • Actions taken to prevent, diagnose, Approved modifications become 1. Data Element and Record/Segment treat, or manage diseases, injuries, and effective October 1 of the following year. Content impairments and any substances, Changes to ICD–9–CM are published on Once we publish the final rule in the equipment, supplies, or other items the NCHS and HCFA websites, as well Federal Register and it is effective, there used to perform these actions; and (2) as by the American Hospital Association will be no additional data element or smaller sets of codes for other data (AHA) and other private sector vendors. record/segment content modifications in elements such as race/ethnicity, type of CPT: Physicians’ Current Procedural any of the transactions for at least one facility, and type of unit. Terminology is used by physicians and year. A separate HIPAA implementation other health care professionals to code In our evaluation and team co-chaired by representatives from their services for administrative recommendation for each proposed HCFA, the Centers for Disease Control/ transactions. CPT is level one of the standard transaction, we have tried to National Center for Health Statistics, Health Care Financing Administration meet as many business needs as and the National Institutes of Health/ Procedure Coding System (HCPCS). possible while retaining our National Library of Medicine, and CPT codes are updated annually by commitment to the guiding principles. including members from other the AMA. The CPT Panel is comprised We encourage comments on how the interested HHS agencies and Federal of 15 physicians, 10 nominated by the standards may be improved. Departments, was established to AMA and one each nominated by Blue It is important to note that all data recommend the code sets that should Cross/Blue Shield of America (BCBSA), elements would be governed by the become HIPAA standards for medical HIAA, HCFA, and AHA. Meetings are principle of a maximum defined data data. HHS efforts to identify candidate not open to the public. set. No one would be able to exceed the medical data code sets were coordinated Alpha-numeric HCPCS: Alpha- data sets defined in the final rule, until with the NCVHS Subcommittee on numeric Health Care Financing that rule is amended one or more years Health Data Needs, Standards, and Administration Procedure Coding from the effective date of the final rule. Security. The smaller sets of codes for System (HCPCS) contains codes for This means that if a transaction has all other data elements in transactions medical equipment and supplies; Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules 25281 prosthetics and orthotics; injectable the diagnosis section of ICD–9–CM and additional systems that may be drugs; transportation services; and other not yet in use in this country. ICD–10 applicable to elements of the claims services not found in CPT. Alpha- was developed by the World Health attachments standard (to be issued on a numeric codes are level 2 of HCPCS. Its Organization and has been implemented later timetable) and to eventual HIPAA use is generally limited to ambulatory in approximately 37 countries to report recommendations to the Congress settings. The Omnibus Budget mortality data. These are data that are regarding full electronic medical Reconciliation Act of 1986 requires the taken and coded from death certificates. records. use of HCPCS in the Medicare program However, since our country’s need for (c) The oral and written testimony for services in hospital outpatient morbidity data cannot be satisfied by submitted at an NCVHS public hearing departments. ICD–10, the United States is preparing to discuss medical/clinical coding and Level II of HCPCS is updated annually a clinical modification of ICD–10 (ICD– classification issues in connection with and is maintained jointly by the BCBSA, 10–CM). The public has been given an the requirements of HIPAA on April 15– the Health Insurance Association of opportunity to review and comment on 16, 1997. The following entities America and HCFA. the current draft of ICD–10–CM. The presented testimony at the hearing: HCFA’s regional offices assure final draft should be available in the AMA, AHA, American Health coordination of local code assignments summer of 1998. Information Management Association, among the payers in a State; local codes • ICD–10–PCS for procedures, which American College of Obstetricians and must be approved by HCFA’s central is under development for use in the U.S. Gynecologists, American Academy of office to assure they do not duplicate only as a replacement to the procedure Pediatrics, American Nurses national codes in CPT or Level II of section of ICD–9–CM. Association, National Association for HCPCS. • CPT, which is used by all Home Care, ADA, Family Practice Decisions regarding additions, physicians and many other practitioners Primary Care Work Group, National deletions and revisions to Level II of to code their services. It is also used by Association of Children’s Hospitals and HCPCS are made by the Alpha-Numeric hospital outpatient departments to code Related Institutions, Food and Drug Editorial Panel. This Panel, which meets certain ambulatory services. Administration, College of American • three times a year, is comprised of SNOMED (Systematized Pathologists, the Omaha System, representatives of the BCBSA, HIAA, Nomenclature of Medicine), which is developers of new nomenclature and HCFA; the meetings are not open to being used by the developers of systems, research groups, publishers, the public. There are formal computer-based patient record systems. consultants in coding, managed care mechanisms to coordinate this Panel’s It is not used in administrative organizations, software vendors, and activities with CPT and the American transactions. informatics specialists. • Dental Association’s (ADA) procedure CDT, which is used by all (d) The NCVHS’ recommendations to coding system. practicing dentists to code their services the Secretary, HHS regarding codes and The revised HCPCS is available free of for administrative transactions. classifications. • charge as a public use file. NIC (Nursing Interventions (e) Comments received in response to CDT: Current Dental Terminology is Classification), which is not used in presentations at professional meetings used in reporting dental services. CDT administrative transactions in this and at the July 9, 1997, public meeting codes are also included in alpha- country. held by HHS on progress on selecting • numeric HCPCS with a first character of LOINC (Logical Observation the initial HIPAA standards. D. Identifier Names and Codes), which is For the hearing on April 15–16, 1997, Codes are revised on a five-year cycle being used in a pilot-test by the Centers the NCVHS invited interested by the ADA through its Council on for Disease Control to report tests as organizations representing both the Dental Benefits Program. Meetings are evidence of a communicable disease. It users and developers of medical/clinical not open to the public. is also being tested in electronic classification systems to present written NDC: National Drug Codes are used in transactions involving detailed clinical and/or oral testimony responding to the reporting prescription drugs in laboratory tests and results. It is not following questions. pharmacy transactions and some claims used in administrative transactions. • HHCC (Home Health Care ‘‘—What medical/clinical codes and by health care professionals. The codes classifications do you use in administrative are assigned when the drugs are Classification system), which is not transactions now? What do you perceive as approved or repackaged and may be being used as a reporting system in this the main strengths and weaknesses of found on the packaging of drugs. country. current methods for coding and (b) A more extensive inventory of classification of encounter and/or i. Candidates for the Standards existing coding and classification enrollment data? The principal sources of input to the systems prepared by the coding and ‘‘—What medical/clinical codes and recommendations for medical data code classification implementation team classifications do you recommend as initial itself and evaluated against the general standards for administrative transactions, sets were: given the time frames in the HIPAA? What (a) The ANSI HISB Standards HIPAA standards evaluation criteria (as specific suggestions would you like to see Inventory. found in section I.B., Process for implemented regarding coding and The inventoried code sets are: developing standards for this proposed classification? ICD–9–CM, which consists of both rule). ‘‘—Prior to the passage of HIPAA, the diagnoses and procedure sections. The This larger inventory (which will be National Center for Health Statistics diagnosis system is widely used in the placed on the home page of the National initiated development of a clinical health care industry. All hospitals and Center for Health Statistics at: http:// modification of the International ambulatory care settings use it to www.cdc.gov/nchswww/ Classification of Diseases-10 (ICD–10–CM), nchshome.htm) does not include any and HCFA undertook development of a capture diagnoses. The procedure new procedure coding system for inpatient system is used for all in patient additional viable candidates for the procedures (called ICD–10–PCS), with a procedure coding. initial standards for administrative code plan to implement them simultaneously in ICD–10–CM for diagnosis, which is sets to be established under this the year 2000. On the pre-HIPAA schedule, under development as a replacement to proposed rule. It does contain some they will be released to the field for 25282 Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules

evaluation and testing by 1998. If some approaches to achieving a more did not address. The implementation version of ICD is to be used for integrated procedure coding system team did not recommend a specific administrative transactions, do you think it were mentioned. Many identified timetable for changes in the standards should be ICD–9–CM or ICD–10–CM and current variations in the after the year 2000. The team believed ICD–10–PCS, assuming that field evaluations are generally positive? implementation of coding systems and that its recommendations for changes ‘‘—Recognizing that the goal of P.L. 104–191 the use of local HCPCS codes as after the year 2000 should await the is administrative simplification, how, from problems that should be addressed. results of field testing of ICD–10–CM for your perspective, would you deal with the In general, those testifying approved diagnosis and ICD–10–PCS for current coding environment to improve the implementation team’s charge, procedures (which should be available simplification, reduce administrative which includes an initial focus on the in March 1998) and further burden, but also obtain medically administrative standards for the year consideration of options for moving meaningful information? 2000 and longer term attention to toward a more integrated approach to ‘‘—How should the ongoing maintenance of recommendations for the more procedure coding. medical/clinical code sets and the clinically-detailed vocabulary needed One of the coding systems that the responsibility, intellectual input and implementation team considered to be funding for maintenance be addressed for for full electronic medical records. the classification systems included in the Some of the developers of vocabularies promising for future implementation standards? What are the arguments for and classifications who presented was the Universal Product Numbers having these systems in the public domain testimony emphasized the potential (UPNs) system. The UPN system is a versus in the private sector, with or usefulness of their systems for full product numbering technology that uses without copyright? computer-based patient records, rather human readable and bar code formats to ‘‘—What would be the resource implications than for the administrative transactions identify products. A bar code and of changing from the coding and that are the focus of the initial HIPAA human readable number, which is classification systems that you currently standards. unique to a particular product, is are using in administrative transactions to Comments on codes and printed on the label or box as part of the other systems? How do you weigh the costs production line process. There are and benefits of making such changes? classifications sets made at the June 3– ‘‘—A Coding and Classification 4, 1997, Health Data Needs, Standards currently two separate and different Implementation Team has been established and Security Subcommittee hearings in UPN coding systems that are generally within the Department of Health and San Francisco, California echoed those accepted and recognized for health care Human Services to address the heard at the April hearing. products. One is numeric, a fixed 14 requirements of P.L. 104–191; the Team’s On June 25, 1997, the NCVHS digit number, and the other an alpha- charge is enclosed. Does your organization submitted the following numeric format, a variable length have any concerns about the process being recommendations to the Secretary of number 8 to 20 digits. The numeric undertaken by the Department to carry out HHS regarding standards for codes and format is the system of the Health Care the requirements of the law in regard to classifications for administrative Uniform Code Council (UCC) and the coding and classification issues? If so, what alpha-numeric format is used by the are those concerns and what suggestions transactions: do you have for improvements?’’ The Committee recommends that diagnosis Health Industry Business and procedure coding continue to use the Communications Council (HIBCC). The In general, those testifying at the April current code sets because replacements will first series of digits are assigned by one 15–16 hearing recommended that not be ready for implementation by the year of these two private companies and systems currently in use be designated 2000. ICD–9–CM diagnosis codes, ICD–9–CM identify the manufacturer or a as standards for the year 2000, since Volume 3 procedure codes, and HCPCS repackager. The remaining digits are (including Current Procedural Terminology potential replacements were not yet assigned by the manufacturer or fully tested and could not be (CPT) and Current Dental Terminology (CDT)) procedure codes should be adopted as repackager and are assigned according implemented throughout the health care the standards to be implemented by the year to the user’s own standards and system by 2000. Testimony supported 2000. Annual updates to ICD–9–CM and specifications. A manufacturer or moving to ICD–10–CM for medical HCPCS should continue to follow the repackager can apply to either one of diagnoses after the year 2000 (different schedule currently used. In addition, we these companies to use its system. The timetables were mentioned). Testimony recommend that you advise industry to build application fees, which are collected by provided by representatives from the and modify their information systems to either UCC or HIBCC, vary based on the American Psychiatric Association accommodate a change to ICD–10–CM manufacturer’s or repackager’s sales described the ongoing efforts to make diagnosis coding in the year 2001 and a major change to a unified approach to coding volume. the Diagnostic and Statistical Manual of procedures (yet to be defined) by the year The Department of Defense has Mental and Behavioral Disorders (DSM) 2002 or 2003. We recommend that you started to use UPNs for its prime vendor completely compatible with ICD. The identify and implement an approach for program. Currently, there are purchasers American Psychiatric Association has procedure coding that addresses deficiencies and providers of medical equipment crosswalked the appropriate ICD–9–CM in the current systems, including issues of that are using the UPN system for codes to what appear in the DSM for its specificity and aggregation, unnecessary inventory purposes, but, at this time, diagnostic categories and is doing the redundancy, and incomplete coverage of there are no insurers that pay for health same for ICD–10–CM for diagnosis. The health care providers and settings. care products using the UPN system. mapping between DSM and ICD–10–CM At the July 9, 1997, public meeting on California Medicaid, however, has plans for diagnosis is more precise than is progress on selecting the HIPAA to begin using UPNs as part of its possible for ICD–9–CM so the APA standards, the implementation team system. favors moving to ICD–10–CM for presented an overview of its planned At this time, approximately 30 diagnosis as soon as possible. recommendations for coding and percent of the health care products do Many of those testifying emphasized classification standards for the year not have a UPN assigned to them. For the need to change to a less fragmented, 2000. The team’s recommendations this reason, in addition to the fact that overlapping, and duplicative approach were similar to those of the NCVHS but no insurer currently uses UPNs for to procedure coding, but sometime after included the use of NDC codes for reimbursement, UPNs were not the year 2000. Different potential pharmacy transactions that the NCVHS included in the initial list of standards. Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules 25283

However, it is a coding system that managed care organizations, also use Level 3 of HCPCS is intended to meet bears close examination during the next HCPCS as a basis for monitoring local needs and is established on a local few years as a possible replacement for utilization and quality of care and for basis by health insurers. There is no alpha-numeric HCPCS codes for health negotiating prospective fees and national registry for these local codes. care products. Some consideration is capitated payments. Research We propose that, beginning in the year being given to conducting a organizations use the HCPCS data 2000, local codes be eliminated and that demonstration study in the Medicare collected by health insurers to monitor a national process be established for program on the use of UPNs for and evaluate these programs and reviewing and approving codes that are reimbursement. regional/national patterns of care. needed by any public or private health Comments on the use of the UPNs as As previously stated, HCPCS alpha- insurer. a national coding system are being numeric codes capture products, The first step in this process would be sought. In particular, comments on supplies, and services not included in to ask public and private health insurers issues such as timing of CPT. The ‘‘D’’ codes in the HCPCS to review the local codes they use and implementation, any complications system are dental codes created by the to immediately eliminate those that presented by the existence of multiple ADA and published as CDT. However, duplicate a national HCPCS code or bodies issuing UPN codes, the in HCPCS, the first digit ‘‘0’’ in CDT is NDC code already in existence. (See the acceptability of varying lengths and replaced by a ‘‘D’’ to eliminate previous section for a discussion of NDC formats, and the frequent changes in confusion and overlap with certain CPT codes.) They would also be asked to manufacture and packaging size would codes. The ADA has agreed to replace eliminate those local codes for which be helpful. their first digit ‘‘0’’ with a ‘‘D’’ so that there are few claims submissions (for CDT can become the national standard. example, fewer than 50 per year) and ii. Changes to HCPCS for There would no longer be dental codes that could reasonably and effectively be Implementation in the Year 2000 within HCPCS. Consequently, CDT reviewed by the health insurer. Health In proposing the use of the existing codes will no longer be issued within insurers would also be asked to coding systems as the standards for the HCPCS as of the year 2000. The ADA eliminate those local codes which were year 2000, many participants at public will be the sole source of the established for administrative purposes, meetings voiced concern about overlaps authoritative version of CDT. to facilitate claims payment, rather than in several of the coding systems, The ‘‘J’’ codes within alpha-numeric to identify and describe medical problems with HCPCS local codes, HCPCS are for drugs. A separate coding services, supplies and procedures. (A differences in implementation of NDC system, the NDC developed by the Food code for ‘‘administration of codes in different systems, and and Drug Administration, is also used to immunization at public health clinic’’ is differences between the CDT codes in report drug claims in the ANSI X12N an example of a code that includes HCPCS and those issued by the ADA. It 837—Health Care Claim: Professional administrative information in addition was repeatedly suggested that these and in pharmacy transactions. The NDC to information about the clinical content issues be resolved and overlaps be system, which has 11-digit codes, is of the service.) This purging would eliminated for standards adopted in the more precise and more current than the result in the elimination of the vast year 2000. After careful consideration of HCPCS ‘‘J’’ codes. NDC identifies drugs majority of local codes now in use. Any all public input and of the options for prescribed down to the manufacturer, remaining local codes would then have modifying HCPCS in the relatively near product name and package size. NDC to be submitted by the health insurer to term, the implementation team is codes are assigned on a continuous HCFA for review and approval as recommending that changes be basis throughout the year as new drug temporary codes. The HCPCS panel implemented in HCPCS in the year 2000 products are issued; ‘‘J’’ codes are currently meets every two to three to reduce its overlap with other coding assigned on an annual basis. Many months to approve requests for systems. providers are currently forced to temporary codes. This process will be HCPCS contains three levels. Level 1, maintain both ‘‘J’’ and NDC codes to re-examined to determine if more CPT, is developed and maintained by provide data to different insurers. The frequent meetings are required. the AMA and captures physician majority of the local codes currently The process would be modeled after services. Level 2, alpha-numeric created were developed because of the the one that is currently used to review HCPCS, contains codes for products, lack of a ‘‘J’’ code for a new drug. Local and approve code requests from supplies, and services not included in codes are level 3 of the HCPCS and are Medicare and its contractors. Codes that CPT. Level 3, local codes, includes all assigned by local insurers or agencies are approved by HCFA would be the codes developed by insurers and where there is no national code. By established as national temporary codes agencies to fulfill local needs. eliminating ‘‘J’’ codes from alpha- that would be posted electronically and We are proposing the adoption of numeric HCPCS codes and utilizing would be available for use by all health HCPCS levels 1 and 2 for only NDC codes for drugs, greater insurers. National temporary codes implementation in the year 2000. In national uniformity can be achieved, the would be reviewed on an annual basis addition, we are proposing to modify workload of providers who previously to make sure they are not duplicative of HCPCS level 3 for the year 2000 to had to utilize two drug coding systems CPT codes or alpha-numeric codes that eliminate overlaps and duplications. will be reduced, and the need for local are newly established. Most third-party public and private codes will diminish substantially. This new centralized process for health insurers (such as Medicare HHS is, therefore, proposing that NDC establishing national temporary codes contractors, Medicaid program and codes become the national standard in would run parallel to the process for fiscal agents, and private commercial the year 2000 for all types of establishing national CPT codes, alpha- health insurers) use HCPCS as a basis transactions requiring drug codes and numeric HCPCS codes, and NDC codes. for paying claims for medical services that ‘‘J’’ codes be deleted from alpha- It is expected that most of the codes provided on a fee-for-service basis and numeric HCPCS. This would require submitted for approval by HCFA in this for monitoring the quality and those handling electronic administrative process would be for new medical utilization of care. In addition, transactions to process 11-digit NDC technologies and services not yet integrated health systems, such as codes in the year 2000. approved for codes by CPT or the alpha- 25284 Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules numeric process or for other medical iii. Recommended Standards and guides for the transaction standards that services/procedures covered by health Implementation Guides require its use. Narrative coding guidelines are insurers which have no associated CPT The proposed standard code sets for presented at the beginning of each of the or alpha-numeric codes. different types of medical data are six sections of print edition of CPT and, These recommendations are based on outlined below: the following: (a) Diseases, injuries, impairments, in addition, special instructions for other health related problems, their specific codes or groups of codes appear As stated earlier, many participants at throughout CPT. CPT is available from public meetings voiced concerns about manifestations, and causes of injury, disease, impairment, or other health- the AMA at a charge as well as from overlaps in codes that are used and the several not-for-profit and other private proliferation of local codes. Local codes related problems. The proposed standard code set for sector vendors. that are duplicative of national codes An area of weakness of the CPT is that these conditions is the International create extra work and confusion for it is not always precise or unambiguous. Classification of Diseases, 9th edition, providers who must submit different However, there are no viable Clinical Modification, (ICD–9–CM), codes to different health insurers. Local alternatives for the year 2000. codes also make it more difficult for Volumes 1 and 2, as maintained and researchers and programs such as distributed by the National Center for (2) Dental Services Medicaid and Medicare to evaluate and Health Statistics, Centers for Disease The proposed standard code set for monitor patterns of care and the Control and Prevention, U.S. these services is the Current Dental utilization and quality of care on a Department of Health and Human Terminology (CDT) as maintained and regional or national basis. Services. The specific data elements for distributed by the ADA for a charge. The which ICD–9–CM is the required code specific data elements for which CDT is The use of local codes established for set are enumerated in the administrative purposes, to facilitate a required code set are enumerated in implementation guides for the the implementation guides for the claims payment rather than to identify transactions standards that require its medical services, supplies and transaction standards that require its use. use. procedures, is contrary to the intent of An area of weakness of the ICD–9–CM the medical coding system, which is The official implementation is that it is not always precise or guidelines for this standard appear in intended to describe medical services unambiguous. However, there are no used to prevent, diagnose, treat or CDT as descriptors that explain the viable alternatives for the year 2000. appropriate use of the codes. Copies of manage diseases, injuries, and Many problems cannot be resolved impairments. Administrative functions the ADA Current Procedural within the current structure, but are Terminology Second Edition (CDT–2) necessary to process and facilitate being addressed in the development of claims by health insurers can be may be obtained by calling 1–800–947– ICD–10–CM for diagnosis, which is 4746. The ADA is in the process of achieved by using ‘‘administrative’’ expected to be ready for implementation codes placed in fields other than those developing CDT–3 for introduction in some time after the year 2000. the year 2000. used for medical diagnosis and The official coding guidelines for this procedure codes or by attaching a proposed standard code set are in the (3) Inpatient Hospital Services modifier to a medical code. Because the public domain and available at no cost The proposed standard code set for need for new temporary codes is not on the NCHS website at: http:// these services is the International unique to an individual health insurer, www.cdc.gov/nchswww/about/ Classification of Diseases, 9th edition, the new codes that are created as a otheract/icd9/icd9hp2.htm. Users Clinical Modification, Volume 3, as result of this centralized process would without access to the Internet may maintained and distributed by the be useful not just to the health insurer purchase the official version of ICD–9– Health Care Financing Administration, who submitted the original request for CM on CD–ROM from the Government U.S. Department of Health and Human a code but also to many other health Printing Office (GPO) at 1–202–512– Services. The specific data elements for insurers across the country. By 1800 or fax 1–202–512–2250. The CD– which ICD–9–CM, Volume 3, is a eliminating duplicative and otherwise ROM contains the ICD–9–CM required code set are enumerated in the unnecessary local codes and adding classification and the coding guidelines. implementation guides for the national temporary codes through the The guidelines are also included in code transactions standards that require its centralized process discussed above, we books and coding manuals published by use. believe we are being consistent with the not-for-profit (for example, the As stated earlier, an area of weakness intent of HIPAA to simplify the American Hospital Association and the of the ICD–9–CM is that it is not always administration of the claims review, American Health Information precise or unambiguous. However, there payment and monitoring process. Management Association) and other are no viable alternatives for the year We welcome comments and private sector vendors. 2000 that are more precise or less suggestions on this proposal for (b) Procedures or other actions taken ambiguous. Many problems cannot be eliminating unnecessary local codes and to prevent, diagnose, treat, or manage resolved within the current structure establishing a centralized, national diseases, injuries and impairments. but are being addressed in the process for establishing national development of ICD–10–PCS for (1) Physician Services temporary codes. We seek input procedures, which is expected to be specifically on the problems and The proposed standard code set for ready for implementation some time barriers to creating this type of process. these entities is the Current Procedural after the year 2000. We are also specifically looking for Terminology (CPT) (level 1 of HCPCS) The official coding guidelines for this examples of the kinds of local codes that as maintained and distributed by the standard are in the public domain and are now being used that would have to AMA. The specific data elements for available at no cost on the NCHS be replaced with national codes or for which CPT (including codes and website at http://www.cdc.gov/ alternatives to the above-described modifiers) is a required code set are nchswww/about/otheract/icd9/ process. enumerated in the implementation icd9hp2.htm. Users without access to Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules 25285 the Internet may purchase the official (d) Drugs improvements in benefits from version of ICD–9–CM on CD–ROM from electronic health care transactions. The proposed standard code set for the Government Printing Office at 1– Improvements in efficiency and these entities is the National Drug Codes 202–512–1800 or fax 1–202–512–2250. effectiveness over the current status quo as maintained and distributed by the The CD–ROM contains the ICD–9–CM will result from: (a) The requirement for Food and Drug Administration, U.S. classification and the coding guidelines. all those exchanging electronic Department of Health and Human The guidelines are also included in code transactions to use a single official Services, in collaboration with drug books and coding manuals published by implementation guide for each manufacturers. The specific data not-for-profit (for example, the recommended code set; and (b) the elements for which NDC is a required American Hospital Association and the proposed changes to HCPCS, which will code set are enumerated in the American Health Information eliminate overlap between NDC and implementation guides for the HCPCS, eliminate one of the two current Management Association) and private transaction standards that require its sector vendors. versions of CDT codes, and eliminate use. the use of local HCPCS codes that are (c) Other Health-Related Services NDC codes as established by the Food known only to institutions that and Drug Administration are made The proposed standard code set for developed them. available on the individual drug • Meet the needs of the health data other health-related services is the package inserts and product labeling. Health Care Financing Administration standards user community, particularly The Food and Drug Administration, health care providers, health plans, and Procedure Coding System (alpha- Center for Drug Evaluation and health care clearinghouses. numeric HCPCS) as maintained and Research, Office of Management, The recommended code sets meet distributed by the Health Care Division of Database Management, some of the needs of the community. To Financing Administration, U.S. prepares an annual update, with meet all of the community’s needs (e.g., Department of Health and Human periodic cumulative supplements of the elimination of overlap in procedure Services. We are proposing to make Approved Drug Products with coding systems and better coverage of significant modifications to alpha- Therapeutic Equivalence Evaluations for nursing and allied health services) will numeric HCPCS for the year 2000. prescription drug products, over the require changes to the code sets These modifications are described in counter drug products and discontinued recommended or their replacement by Section II.D.2.a.ii of this proposed rule. drug products. The supplements are newer systems, once these have been The specific data elements for which available on diskette, on a quarterly fully tested and revised. Essentially all alpha-numeric HCPCS (including codes basis, from the National Technical segments of the health care community and modifiers) is a required code set are Information Service at 703–487–6430. testified that there was no practical enumerated in the implementation The files are also available on the alternative to the recommended code guides for the transaction standards that Internet’s World Wide Web on the CDER sets for the year 2000, although they require its use. Home Page at http://www.fda.gov/cder. recommended changes after that time. The NDC codes are also published in Alpha-numeric HCPCS codes meet all • Be consistent and uniform with the such drug publications as the but one of the guiding principles for other HIPAA standards—their data Physicians’ Desk Reference under the choosing standards. An area of element definitions and codes and their individual drug product listings and weakness is that it is not always precise privacy and security requirements— ‘‘How supplied.’’ or unambiguous. However, there are no and, secondarily, with other private and viable alternatives for the year 2000 that (e) Other Substances, Equipment, public sector health data standards. are more precise or less ambiguous. Supplies, or Other Items Used in Health All of the recommended code sets are Some of the areas of ambiguity in Care Services required for selected data elements in HCPCS (the ‘‘J’’ codes for drugs, local more than one of the recommended The proposed standard code set for codes, variant CDT codes) have been transaction standards. these entities is the Health Care • addressed in the changes recommended Have low additional development Financing Administration Procedure for the year 2000. and implementation costs relative to the Coding System (alpha-numeric HCPCS) benefits of using the standard. The 1998 alpha-numeric HCPCS file as maintained and distributed by the The recommended code sets are (excluding the D procedure codes Health Care Financing Administration, currently used by many segments of the copyrighted by the ADA) is available U.S. Department of Health and Human health care community. from the HCFA website at http:// Services. We are proposing to make • Be supported by an ANSI- www.hcfa.gov/stats/pufiles.htm. Users significant modifications to alpha- accredited standards developing can also access this page by taking the numeric HPCPS for the year 2000. These organization or other private or public Stats and Data link to the Browse/ modifications are described in Section organization that will ensure continuity Download available PUFs link. The II.D.2.a.ii of this proposed rule. The and efficient updating of the standard 1998 alpha-numeric HCPCS file is on specific data elements for which alpha- over time. the HCFA Public Use Files page under numeric HCPCS is a required code set All of the recommended code sets are the Utilities/Miscellaneous heading. are enumerated in the implementation supported by U.S. government agencies The HCPCS is in an executable guides for the transactions standards or private sector organizations that have format, which includes 1998 alpha- that require its use. demonstrated a commitment to numeric HCPCS in both Excel and text, The recommended code sets adhere to maintaining them over time. the 1998 Alpha-Numeric Index in both the principles for guiding choices for • Have timely development, testing, Portable Document Format (PDF) and the standards to be adopted under implementation, and updating text, the 1998 Table of Drugs in both HIPAA as follows: procedures to achieve administrative PDF and text, the 1998 HCPCS record • Improve the efficiency and simplification benefits faster. layout in WordPerfect and text, and a effectiveness of the health care system All of the recommended code sets read me file in WordPerfect and text. by leading to cost reductions for or have existing procedures for updating at 25286 Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules least annually. NDC updates continually NCVHS hearings previously discussed, In § 142.1010, The requirements throughout the year. changes will be required to address sections of part 142, subparts K through • Be technologically independent of current coding system deficiencies that R, would specify that those who the computer platforms and adversely affect the efficiency and transmit electronic transactions covered transmission protocols used in quality of administrative data creation by the transaction standards must use electronic health transactions, except and to meet international treaty the appropriate transaction standard, when they are explicitly part of the obligations. For example, ICD–10–CM including the code sets that are required standard. for diagnosis is highly likely to replace by that standard. These sections would All of the recommended code sets are ICD–9–CM as the standard for diagnosis further specify that those who receive technologically independent of data, possibly in 2001. When any of the electronic transactions covered by the computer platforms and transmission standard code sets proposed in this rule transaction standards must be able to protocols. are replaced by wholly new or receive and process all standard codes, • Be precise and unambiguous, but as substantially revised systems, the new without regard to local policies simple as possible. standards may have different code regarding reimbursement for certain There are some problems with lack of lengths and formats. The current draft of conditions or procedures, coverage precision and ambiguity in all the ICD–10–CM for diagnoses contains 6 recommended code sets, but there are digit codes; the longest ICD–9–CM policies, or need for certain types of no viable alternatives for the year 2000. codes have 5 digits. In addition to information that are not part of a In the case of ICD–9–CM, many accommodating the initial code sets standard transaction. problems cannot be resolved within the standards for the year 2000, those that E. Transaction Standards current structure but are being produce and process electronic addressed in the development of ICD– administrative health transactions The HISB prepared an inventory of 10–CM for diagnosis and ICD–10–PCS should build the system flexibility that candidate standards to be considered by for procedures, which are expected to be will allow them to implement different HHS in the standards adoption process. ready for implementation some time code formats beyond the year 2000. HHS wrote letters to the NUBC, the after 2000. Some of the sources of As also clearly expressed in the NUCC, the ADA, and WEDI in order to ambiguity in HCPCS (the ‘‘J’’ codes for hearings and other input to HHS, any consult with them as required by the drugs, local codes, variant CDT codes) major change in administrative coding Act. HHS also consulted with them have been addressed in the changes systems involves significant initial costs recommended for the year 2000. The informally and received their support and dislocations, as well as some level movement to a single framework for on all the transactions at various of discontinuity in data collected before procedure coding, sometime after the meetings and at the public meeting we and after the change. These factors must year 2000, will address other known held on July 9, 1997, in Bethesda, be weighed against expected problems with the procedure codes. Maryland. The NCVHS held public improvements in the efficiency of data • Keep data collection and paperwork hearings during which any person could creation and in the accuracy and utility burdens on users as low as is feasible. present his or her views. There also of the data collected. In the future, more Because the recommended code sets were opportunities for those who could flexible health data systems may assist are currently used throughout the health not attend the public hearings to in reducing the costs of implementing care community, they should not add provide written advice, and many did changes in administrative coding and substantially to data collection or take advantage of that opportunity. In classification standards, especially if paperwork burdens. addition, HHS welcomed informal administrative codes can be generated • Incorporate flexibility to adapt more automatically from more granular advice from any industry member, and easily to changes in the health care clinical data. that advice was taken into consideration infrastructure (such as new services, during the decision making process. organizations, and provider types) and b. Requirements information technology. Recommendations for enrollment and Some of the recommended code sets In § 142.1002, we would state that disenrollment in a health plan, lack a desirable level of flexibility; e.g., health plans, health care clearinghouses, eligibility for a health plan, health care they use hierarchical codes and may and health care providers must use in payment and remittance advice, health therefore ‘‘run out of room’’ for electronic transactions the diagnosis plan premium payments, first report of additional codes required by advances and procedure code sets as prescribed injury, health claim status, and referral in medicine and health care. Since they by HHS. The names of these diagnosis certification and authorization were appear to be the only feasible and procedure code sets are published overwhelmingly in favor of ASC X12N alternatives for the year 2000, steps in a notice in the Federal Register. The implementations. Also, the should be taken to improve their implementation guides for the recommendation for the National flexibility—or replace them with more transaction standards in part 142, Council of Prescription Drug Programs flexible options—sometime after the Subparts K through R would specify (NCPDP) version 3.2 telecommunication year 2000. which of the standard medical data code standard format was not controversial sets should be used in individual data and was nearly unopposed. iv. Probable Changes to Coding and elements within those transaction Classification Standards After 2000 standards. The recommendations for the Although the exact timing and precise In § 142.1004, we would specify that professional and institutional claims nature of changes in the code sets the code sets in the implementation were quite controversial, with some designated as standards for medical data guide for each transaction standard in factions supporting the de facto flat file are not yet known, it is inevitable that part 142, subparts K through R, are the standards that have been in use for there will be changes to coding and standard for the coded nonmedical data many years and others supporting X12N classification standards after the year elements present in that transaction standards. 2000. As indicated in testimony at the standard. Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules 25287

(A flat file is a file that has fixed- However, we are proposing that version for adoption, with content based on de length records and fixed-length fields.) 4010 would be proposed in lieu of facto standards derived over time. Some associations proposed dual version 3070 for the following reasons: i. Candidates for the Standard standards with the flat file claim • Version 4010 is millennium ready. standards (National Standard Format for • Version 4010 allows for up-to-date The HISB developed an inventory of professional claims and electronic UB– changes to be incorporated into the health care information standards for 92 for institutional claims) to sunset on standards. HHS to consider for adoption. The a specified date, at which time the We will propose a claims attachment candidate standards for health claims or parallel ASC X12N claim standard in a separate document as the equivalent encounter information were: • implementations would become the sole statute gives the Secretary an additional Retail drug: NCPDP standards to be used. year to designate this standard. The Telecommunications Standard Format The HHS claims implementation team attachment standards are likely to be Version 3.2. • recommended, and we are proposing for drafted so that health care providers Dental claim: ASC X12N 837— adoption, the following standards as using Health Level 7 (HL7) for their in- health care claim: dental, version 3070 house clinical systems would be able to implementation. implemented through the appropriate • implementation guides, data content send HL7 clinical data to health plans. Professional claim: ASC X12N and data conditions specifications, and Anyone wishing to use the HL7 may 837—health care claim: Professional, data dictionary: want to consider a translator that version 3070 implementation and HCFA • Health care claim and equivalent supports the administrative transactions National Standard Format (NSF), encounter: proposed in this proposed rule and the version 002.00. + Retail drug: NCPDP HL7. + Institutional claim: ASC X12N Telecommunication Claim version 3.2 We will also propose a standard for 837—health care claim: institutional, or equivalent NCPDP Batch Standard first report of injury transactions in a version 3070 implementation and HCFA Version 1.0. later rule for reasons explained in depth Uniform Bill (UB–92) version 4.1 + Dental claim: ASC X12N 837— under section II.E.9. ii. Recommended Standards Health Care Claim: Dental. 1. Standard: Health Claims or + Professional claim: ASC X12N The four standards for claims or Equivalent Encounter Information 837—Health Care Claim: Professional. equivalent encounter information we (Subpart K) are proposing in this proposed rule are: + Institutional claim: ASC X12N • 837—Health Care Claim: Institutional. [Please label any written comments or e- Retail drug: NCPDP • Health care payment and remittance mailed comments about this section with the Telecommunications Standard Format advice: ASC X12N 835—Health Care subject: Health Claims] Version 3.2 and equivalent NCPDP Batch Standard Version 1.0. Payment/Advice. a. Background • Coordination of benefits: The NCPDP was formed in 1977 as + Retail drug: NCPDP By the mid-1970s, several health care the result of a Senate Ad Hoc Committee Telecommunication Standard Format industry associations had formed to study standardization within the version 3.2 or equivalent NCPDP Batch committees to attempt to standardize pharmacy industry. The NCPDP was Standard Version 1.0. paper health care claim or equivalent specifically named in HIPAA as a + Dental claim: ASC X12N 837— encounter forms. By the mid-1980s, standards setting organization Health Care Claim: Dental. those committees were standardizing accredited by ANSI. The first NCPDP + Professional claim: ASC X12N electronic formats with equivalent data. Telecommunications Standard was 837—Health Care Claim: Professional. By the early 1990s, some of these developed in 1988 and allowed + Institutional claim: ASC X12N committees were working with the ASC pharmacists to process claims in an 837—Health Care Claim: Institutional. X12N Subcommittee. Nevertheless, interactive environment. The NCPDP • Health claim status: ASC X12N 276/ many health plans continued to require developed the Telecommunications 277—Health Care Claim Status Request local formats, revising the formats to Standard Format for electronic and Response. suit their own purposes rather than communication of claims between • Enrollment and disenrollment in a following procedures in order to revise pharmacy providers, insurance carriers, health plan: ASC X12 834—Benefit the standards. As a result, it is not third-party administrators, and other Enrollment and Maintenance. unusual for health care providers to responsible parties. The standard • Eligibility for a health plan: ASC support many electronic health care addresses the data format and content, X12N 270/271—Health Care Eligibility claim formats, either directly or by the transmission protocol, and other Benefit Inquiry and Response. using clearinghouse services, in order to appropriate telecommunications • Health plan premium payments: do business with the many health plans requirements. The NCPDP received ASC X12 820—Payment Order/ covering their patients. input from all aspects of the Remittance Advice. The committees that pursued prescription drug industry and designed • Referral certification and organizational goals (such as a more the standard to be easy to implement authorization: ASC X12N 278—Health cost-efficient environment for the and flexible enough to respond to the Care Services Review—Request for provision of health care, more time and changing needs of the industry. The Review and Response. resources for patient care, and fewer NCPDP also provides changes and We chose version 4010 of X12 for resources for administration) were additions to the standard to support each ASC X12N transaction. Later in usually sponsored by health care unique requirements included in this proposed rule is a list of candidates provider associations such as the government mandates. for most transactions. The ASC X12N National Council of Prescription Drug The NCPDP telecommunications transactions listed as candidate Programs, the AMA, the American standard for claim and equivalent standards in this section were originally Hospital Association, and the ADA. encounter data is on-line interactive. specified as version 3070 because at the Each association contributed to the There is also a batch implementation of time of HISB inventory version 3070 development of the four corresponding this standard, the NCPDP Batch was the most current DSTU version. accredited claims standards proposed Standard Version 1.0. The 25288 Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules telecommunications standard data set organizations included entities functions (such as claims and includes eligibility/enrollment, claim, representing all parts of the health care remittance advice), with the exception and remittance advice information. industry—health care providers, health of the NCPDP transaction, have all been When the transaction is complete, the plans, and vendors/clearinghouses—to recommended to be ASC X12N sending pharmacy knows whether the which the standard will apply. transactions. The ASC X12N 837 met all customer is covered by the health plan, The ASC X12N 837 standard met all 10 criteria used to assess the standards. the health plan knows all of the details 10 criteria used to assess standards. The The UB–92 met 5 of the criteria. The of the claim, the pharmacy knows NSF met 5 of the criteria. The NSF does UB92 does not improve the efficiency whether the claim will be paid, and how not improve the efficiency and and effectiveness of the health care much it will be paid, and any pertinent effectiveness of the health care system system (#1) because a standard details regarding the amount of payment (#1) because a standard implementation implementation does not exist. The or the reason for denial of payment. does not exist. The NSF meets the needs UB92 is not supported by an ANSI- This standard met all 10 of the criteria of many users, particularly Medicare, accredited SDO (#5). There are no used to assess standards. but not all of the needs of the user testing or implementation procedures in Since retail drug claims are a community (#2). It is not supported by place (#6). The UB92 documentation is specialized class and the NCPDP an ANSI-accredited SDO (#5). There are ambiguous in some instances and not structure contains claims, enrollment/ no testing or implementation always precise (#8). Due to its fixed- eligibility and remittance advice data, procedures in place (#6). Due to its length structure, it does not incorporate we did not recommend the ASC X12N fixed-length structure, it does not flexibility to adopt easily to change 837 for the retail drug standard. incorporate flexibility to adapt easily to (#10). The NUBC stated it would • Dental claim: ASC X12N 837— change (#10). consider the 837, once successfully Health Care Claim: Dental. Institutional claim: ASC X12N 837— tested. For these reasons, we have The ADA recommended adoption of Health Care Claim—Institutional. concluded that the ASC X12N 837 the ASC X12N 837, version 3070. This HHS consulted with the groups should be adopted as the standard standard met all of the criteria used to identified under our discussion of the format implementation of the assess standards. standard for professional claims above institutional claim. Professional claim: ASC X12N 837— in this section and also consulted with For the most part, a health care Health Care Claim: Professional. the NUBC on the selection of an provider would use only one of these HHS consulted with external groups institutional standard. In a letter dated four health care claim implementations, in accordance with the legislation. March 11, 1997, the NUBC stated, although a large institution might use These groups included the NCVHS, The NUBC recommends the use of the the institutional claim for inpatient and WEDI, the NUCC, the NUBC, the ADA, EMC V.4 (UB–92) as the single electronic outpatient claims, the professional and many others. standards transaction for institutional health claim for staff physicians who see In a letter, dated March 12, 1997, the claims and encounters. We recommend the private patients within the institution, EMC V.4 for the following reasons: NUCC stated, and the retail pharmacy claim, if —Nearly all institutional providers already applicable, which typically would be The NUCC recommends to the Secretary of use the EMC V.4 with a high level of HHS that the ANSI ASC X12 837 transaction success. administered separately from the rest of be adopted as a standard for electronically —The EMC V.4 has been in full production the institution. transmitting professional claims or for over four years. Data elements for the various equivalent encounters, including —There is no additional cost for providers to standards and other information may be coordination of benefits information, as per adopt the EMC V.4. found in Addendum 1. the Administrative Simplification provision —It reduces the risks associated with the of the HIPAA. adoption of a new, complex and relatively b. Requirements The NUCC recommends that a migration untested transaction. plan be adopted to allow current trading —It allows for a more successful transition to In § 142.1102, we would specify the partners who use the National Standard the 837. exact standards we are adopting: the format (NSF) to convert to a standard NSF, We agree with HCFA that coordination of NCPDP Telecommunications Standard which will be implemented by the Secretary benefits transactions (COB) do not require a Format Version 3.2 and equivalent per the HIPAA, by February 2000 and to fully separate transaction for the health care NCPDP Batch Standard Version 1.0; the convert to the standard ANSI ASC X12 837 claim or encounter. The NUBC also believes ASC X12N 837—Health Care Claim: by February 2003. that the EMC V.4 should be used as the Dental, the ASC X12N 837—Health Care The AMA also supported the NUCC platform for transmitting COB data elements. Claim: Professional, and the ASC X12N recommendation. However, the NCVHS At the present time, the NUBC cannot 837—Health Care Claim: Institutional. recommend the use of the 837 as the We would specify where to find the and WEDI recommended adoption of electronic institutional claim standard. the ASC X12N 837 transaction. The We recommend that larger scale testing of implementation guide and incorporate it claims implementation team decided the 837 proceed. Once the transaction has by reference. that, since the NUCC was clear that it proven that it can successfully handle the i. Health plans. wanted the ASC X12N 837 transaction claim/encounter, the NUBC will consider In § 142.1104, Requirements: Health in the end, it would be better to invest endorsing the 837 as a successor standard. plans, we would require health plans to in migrating to that, rather than support The American Hospital Association accept only the standards specified in two standards and take more time for also supported NUBC’s § 142.1102 for electronic health claims the transition. recommendation. The NCVHS and or equivalent encounter information. Our recommendation takes into WEDI recommended adoption of the ii. Health care clearinghouses. account the advice we received from ASC X12N 837 transaction. We would require in § 142.1106 that organizations that we consulted directly Due to the batch nature of the ASC each health care clearinghouse use the and indirectly and from those who X12N transactions, each transaction standard specified in § 142.1102 for testified before the NCVHS type and its corresponding data health claims or equivalent encounter subcommittee on Health Data Needs, elements are separated by function. The information transactions. Standards, and Security. These adoption of the transactions for those iii. Health care providers. Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules 25289

In § 142.1108, Requirements: Health those records, reconciliation of providers and health plans in the ASC care providers, we would require each payments sent to financial institutions, X12N Subcommittee rejected the ASC health care provider that transmits and storage and retrieval of patient X12N 820 due to its lack of health care health claims and encounter equivalent accounts is a very labor intensive specific information for this function. electronically to use the standard process when conducted manually. The The X12N 820 is used for electronic specified in § 142.1102. process is further complicated by the payment of health insurance premiums diverse requirements and processes for c. Implementation Guide and Source by employers. Although the NSF is used activities such as billing, payment, and by a large number of Medicare The source of implementation guides notification of the large number of providers, we rejected it because it is for the NCPDP telecommunication claim health plans, which requires that health not an ANSI-accredited standard and it version 3.2 and equivalent NCPDP care provider staff stock multiple types lacks an independent, nongovernmental Batch Standard Version 1.0 is the of forms, be trained in the variety of body for maintenance. National Council for Prescription Drug requirements, be able to interpret the Programs, 4201 North 24th Street, Suite wide range of coding schemes used by The ASC X12N 835 may be used in 365, Phoenix, AZ, 85016; telephone each health plan, and maintain billing conjunction with payment systems 602–957–9105; FAX 602–955–0749. The and payment manuals for each health relying either on electronic funds web site address is: http:// plan. transfer or the creation of paper checks. www.ncpdp.org. We believe that automation can It may be sent through the banking NCPDP standards are available to the greatly reduce the labor required for system or it may be split with the public on a 31⁄2’’ diskette for a fee. A set these processes, especially if every electronic funds transfer portion is defined as containing the health plan becomes automated around directed to a bank, and the data portion Telecommunications Standard, a standard model so that health care sent either directly or through a health Standard Claims Billing Tape Format, providers are not required to deal with care clearinghouse to the individual for Eligibility Verification and Response, different requirements and software. whom the funds are intended. If paper and Enrollment. Membership in the Automation of the payment and checks are used, the entire transaction is NCPDP is not a requirement for remittance advice process can provide sent either directly or through a health obtaining the standards and associated many benefits: health care providers can care clearinghouse to the individual for implementation guides. The website post claim decisions and payments to whom the funds are intended. In all contains information and instructions accounts without manual intervention, cases, however, the health care provider for obtaining these documents. eliminating the need for re-keying data; may use the electronic data in its own The implementation guides for the payments can be automatically system, gaining efficiency by means of ASC X12N standards are available at no reconciled with patient accounts; and automatic posting of patient accounts. cost from the Washington Publishing resources are freed to address patient Uniformity is just as important as it is Company site at the following Internet care rather than paper and electronic for health care claims, since there would address: http://www.wpc-edi.com/ administrative work. be little gain in efficiency for the health hipaa/. The ASC X12N Subcommittee care provider who must adapt to Users without access to the Internet established a workgroup in late 1991 to multiple formats and multiple data may purchase implementation guides develop the ASC X12N 835—Health contents for remittance advice. This from Washington Publishing Company Care Claim Payment/Advice, since there transaction is suitable for use only in directly: Washington Publishing was no existing standard capable of batch mode. Company, 806 W. Diamond Ave., Suite handling the large datasets necessary for 400, Gaithersburg, MD, 20878; health care. HHS, based on recommendations, has telephone 301–590–9337; FAX: 301– determined that the ASC X12N 835— 869–9460. The data definitions and i. Candidates for the Standards Health Care Claim Payment/Advice is description of data conditions may also Prior to development of the ASC the best candidate for adoption under be obtained from this website. X12N 835, there were very few HIPAA. A wide range of the health care The names of the implementation electronic formats available for the community participated in its initial guides are: health care claim payment and design, and the ASC X12N is ANSI- ASC X12N 837—Health Care Claim: remittance advice function. As accredited. Whereas the NSF met 5 of Professional (004010X098) researched by the HISB, existing the criteria against which we evaluated ASC X12N 837—Health Care Claim: standards that could be considered for the standards, the ASC X12N standards Institutional (004010X096) national implementation under HIPAA met all 10. The NSF does not improve ASC X12N 837—Health Care Claim: for health care claim payment/ the efficiency and effectiveness of the Dental (004010X097) remittance advice included: health care system (#1) because a ASC X12N 835—Health Care Claim standard implementation does not exist. 2. Standard: Health Care Payment and Payment/Advice, version 3070; ASC The NSF was developed primarily for Remittance Advice (Subpart L) X12N 820 Payment Order/Remittance Medicare and, therefore, does not meet [Please label any written comments or e- Advice; and the National Standard all of the needs of the user community mailed comments about this section with the Format (NSF) for Remittance Version (#2). It is not supported by an ANSI- subject: Payment] 2.0 accredited SDO (#5). There are no a. Background ii. Recommended Standard testing or implementation procedures in place (#6). Due to its fixed-length The filing of claims for The standard for remittance advice structure, it does not incorporate reimbursement (especially when a large proposed in this proposed rule is the flexibility to adapt easily to change number of patients have more than one ASC X12N 835 Health Care Claim # insurer), control of those claims, Payment/Advice. ( 10). association of payments, denials or HHS chose this standard primarily Data elements for the standard and rejections received with the patient because of advice received from other information may be found in records, posting of adjudication data to industry members. Health care Addendum 2. 25290 Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules b. Requirements the coordination of benefits for patients described in the second model. If, In § 142.1202, we would specify the covered by multiple health plans is a however, a plan does conduct COB ASC X12N 835 Health Care Claim burdensome chore. The COB transaction through the second model, then it Payment/Advice (004010X091) as the differs somewhat from the others would be required to use the standard standard for payment and remittance because there are two models in format. Primary insurers may determine advice transactions. We would also existence for conducting it. The first whether they wish to participate in COB specify the source of the model is provider-to-plan, where the transactions (i.e., use the second model) implementation guide and incorporate it provider submits the claim to the based on their normal business by reference. primary insurer, receives payment, and practices. Where primary insurers do i. Health plans. resubmits the claim (with the remittance perform COB (using the second model) In § 142.1204, Requirements: Health advice from the primary insurer) to the they must conduct the transaction plans, we would require health plans to secondary insurer. The second model is electronically as standard transactions. use only the standard specified in plan-to-plan, where the provider The ASC X12N 837 Health Care Claim § 142.1202 for electronically supplies the primary insurer with (refer to E.1. above) is designed to transmitting payment and remittance information needed for the primary facilitate coordination of benefits. Each advice transactions. insurer to then submit the claim directly health plan responsible for the claim ii. Health care clearinghouses. to the secondary insurer. The choice of passes the claim on to the next health We would require in § 142.1206 that model has been made between the plan responsible for the claim. This each health care clearinghouse use the providers and plans. Where the first transaction describes the original claim standard specified in § 142.1202 for model is used, the primary insurer and how previous health plans payment and remittance advice essentially has no role in the COB adjudicated the claim. In October 1994, transactions. transaction. Put another way, in the first the ASC X12N Subcommittee modified model there is no separate COB the ASC X12N 837 Health Care Claim to c. Implementation Guide and Source transaction. Instead, the COB function is fully support coordination of benefits. The implementation guide for the accomplished by a health care provider ASC X12N 835 (004010X091) is submitting a series of individual claims. i. Candidates for the Standard available at no cost from the This succession of transactions from a. Retail drug: NCPDP Washington Publishing Company site at health care provider to primary health Telecommunications Standard Format the following Internet address: http:// plan to health care provider to version 3.2. www.wpc-edi.com/hipaa/. secondary health plan, which often b. Dental claim: ASC X12N 837— Users without access to the Internet involves the production, reproduction, Health Care Claim: Dental, version 3070. may purchase implementation guides and mailing of paper forms and multiple c. Professional claim: ASC X12N from Washington Publishing Company claim formats, is time consuming and 837—Health Care Claim: Professional, directly: Washington Publishing administratively costly. In some version 3070. Company, 806 W. Diamond Ave., Suite instances, it becomes even more d. Institutional claim: ASC X12N 400, Gaithersburg, MD 20878; telephone burdensome when the provider shifts 837—Health Care Claim: Institutional, 301–590–9337; FAX: 301–869–9460. responsibility for these administrative version 3070; and the Uniform Bill (UB– The data definitions and description of tasks to the patient. Health plans have 92) version 4.1. been unwilling to take on the full data conditions may also be obtained ii. Recommended Standard from this website. responsibility for coordinating benefits because of the many different forms and The standards for the coordination of 3. Standard: Coordination of Benefits formats used for these transactions. benefits exchange we are proposing are: (Subpart M) Administrative simplification and a. Retail drug: NCPDP [Please label any written comments or e- electronic standards can simplify and Telecommunications Standard Format mailed comments about this section with the smooth this onerous process. The four version 3.2 and the equivalent NCPDP subject: COB] products of administrative Batch Standard Version 1.0. simplification—(1) The uniform b. Dental claim: ASC X12N 837— a. Background standards for electronic claims Health Care Claim: Dental In an effort to provide better service submissions; (2) an electronic (004010X097). to their customers, many health plans transmission standard for coordination c. Professional claim: ASC X12N have made arrangements with each of benefits; (3) a uniform national 837—Health Care Claim: Professional other to send claims electronically in standard for the data elements necessary (004010X098). the order of payment precedence, thus for coordination of benefits among d. Institutional claim: ASC X12N saving the customer the process of health plans; and (4) uniform health 837—Health Care Claim: Institutional waiting for another health plan’s notice. plan and provider identification (004010X096). Each health plan in the chain wishes to numbers to efficiently route electronic Since all recommended transactions see the original claim as well as the transactions—would combine to remove for claims or equivalent encounters and details of its adjudication by prior the barriers that health plans currently the remittance advice are ASC X12N, health plans that dealt with it. We face in carrying out transactions. These with the exception of the NCPDP, it was believe that there should be a products would facilitate the process of determined that this transaction was the coordination of benefits standard to the second model, direct health plan to best candidate for national facilitate the interchange of this health plan coordination of benefits. implementation, as it will increase the information between health plans. Once these standards are implemented, synergistic effect of the other ASC X12N Adoption of a standard for electronic coordination of benefits could be standards. transmission of standard data elements completed without provider or patient All health plans who perform COB, among health plans for coordination of intervention and at a lower cost to all using the second model described benefits and sequential processing of parties than under current practice. above, would have to send and receive claims would serve these goals Primary insurers are not required to these standards for coordination of expressed by the Congress. Currently, participate in COB transactions as benefits. The data elements added to Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules 25291 explain the prior payments on the claim at no cost from the Washington The ASC X12N Subcommittee are shown in the implementation guide, Publishing Company site at the established a workgroup (Workgroup 5 data conditions, and data dictionary. following Internet address: http:// Claims Status) to develop a standard This transaction accommodates www.wpc-edi.com/hipaa/. The data implementation with standard data coordination of benefits through the definitions and description of data content for all users of the ASC X12N tertiary health plan. The NCPDP conditions may also be obtained from 276/277 Health Care Claim Status telecommunication claim version 3.2 is this website. Request and Response (004010X093). interactive. The three X12 standards are Users without access to the Internet The ASC X12N 276 is used to designed for use only in batch mode. may purchase implementation guides transmit request(s) for status of specific HHS chose these standards primarily from Washington Publishing Company health care claim(s). Authorized entities because of advice received from directly. Washington Publishing involved with processing the claim need industry members. Company, 806 W. Diamond Ave., Suite to track the claim’s current status Data elements for the various 400, Gaithersburg, MD, 20878; through the adjudication process. The standards and other information may be Telephone 301–590–9337; FAX: 301– purpose of generating an ASC X12N 276 found in Addendum 3. 869–9460. is to obtain the current status of the b. Requirements The names of the implementation claim. Status information can be guides are: requested at various levels. The first In § 142.1302, we would specify the level would be for the entire claim. A following as the standards for ASC X12N 837—Health Care Claim: Professional (004010X098) second level of inquiry would be at the coordination of benefits: the NCPDP service line level to obtain status of a Telecommunications Standard Format ASC X12N 837—Health Care Claim: Institutional (004010X096) specific service within the claim. Version 3.2 and equivalent NCPDP The ASC X12N 277 Health Care Claim Batch Standard Version 1.0; the ASC ASC X12N 837—Health Care Claim: Dental (004010X097) Status Response is used by the health X12N 837—Health Care Claim: Dental plan to transmit the current status (004010X097); the ASC X12N 837— 4. Standard: Health Claim Status within the adjudication process. This Health Care Claim: Professional (Subpart N) can include status in various locations (004010X098); and the ASC X12N 837— [Please label any written comments or e- within the adjudication process, such as Health Care Claim—Institutional pre-adjudication (accepted/rejected (004010X096). We would specify where mailed comments about this section with the subject: Status] claim status), claim pending to find the implementation guide and development, suspended claim(s) incorporate it by reference. a. Background information, and finalized claims status. i. Health plans. In § 142.1304, Requirements: Health Health care providers need the ability Prior to the development of the ASC plans, we would require health plans to obtain up to date information on the X12N 276/277 Health Care Claim Status who perform COB to use only the status of claims submitted to health Request and Response, there were very standards specified in § 142.1302 for plans for payment, and the health plans few proprietary or other electronic electronic coordination of benefits need a mechanism to respond to these formats available for this type of claims transactions. requests for information. The current status, and none were in widespread ii. Health care clearinghouses. processes are complicated by the use. No existing standard was accepted We would require in § 142.1306 that diverse processes within health plan for national use by the health care each health care clearinghouse use the adjudication systems, which permit community. As researched by the HISB, standards specified in § 142.1302 for nonstandard information to be provided only one standard could be considered coordination of benefits. on the status of claims submitted. Most for national implementation under health care providers currently request HIPAA for health care claim status c. Implementation Guide and Source claims status information manually. request and response: the ASC X12N The source of implementation guides This requires health plans to provide 276/277 Health Care Claim Status for the NCPDP telecommunication claim information through various procedures Request and Response, version 3070. that are costly and time consuming for version 3.2 and equivalent Standard i. Candidates for the Standard Claims Billing Tape Format is the all. National Council for Prescription Drug With the paper model of claims The candidate standard for health Programs, 4201 North 24th Street, Suite processing, inquirers who want to know care claim status is: 365, Phoenix, AZ, 85016; Telephone the status of a claim they have ASC X12N 276/277 Health Care Claim 602–957–9105, FAX 602–955–0749. The submitted to a health plan call the Status Request and Response, version web site address is: http:// health plan. An operator looks up the 3070. status via computer terminal or some www.ncpdp.org. NCPDP standards are ii. Standard Selected available to the public on a 31⁄2′′ other means and explains the status to diskette. A set is defined as containing the caller. The health claim status tells We propose to adopt ASC X12N 276/ the Telecommunications Standard, the inquirer whether the claim has been 277 Health Care Claim Status Request Standard Claims Billing Tape Format, received, whether it has been paid, or and Response (004010X093), as the Eligibility Verification and Response, whether it is stopped in the system national standard for uniform use by and Enrollment. Membership in the because of edit failures, suspense for health plans and health care providers NCPDP is not a requirement for medical review or some other reason. for health care claims status. obtaining the standards and associated Many health plans have devised their HHS chose this standard primarily implementation guides. The website own electronic claims status because of advice received from contains information and instructions transactions since this is a function that industry members. It met all 10 of the for obtaining these formats. is cheaper, easier, and faster to do criteria used for assessing standards. The implementation guides for the electronically. This transaction eases Data elements for the standard, and three ASC X12N health care claim administrative burden for both health other information, may be found in standard implementations are available plan and health care provider. Addendum 4. 25292 Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules b. Requirements maintenance information on their by sponsors, the ANSI ASC X12 834 met In § 142.1402, we would specify the employees for insurance products other all of the 10 criteria deemed to be following as the standard for health care than health. It has rarely been used applicable in evaluating this potential claims status: ASC X12N 276/277 within the health care industry. standard. Health Care Claim Status Request and i. Candidates for the Standard. 1. It will improve the efficiency of According to the inventory conducted Response (004010X093). We would enrollment transactions by prescribing a for HHS by the HISB, only two specify where to find the single, standard format. standards developed and maintained by 2. It was designed to meet the needs implementation guide and incorporate it a standards developing organization for of health care providers, health plans, by reference. the enrollment transaction exist. The i. Health plans. and health care clearinghouses by virtue In § 142.1404, Requirements: Health first is the ANSI ASC X12 834. The of its development within the ASC X12 plans, we would require health plans to second is the Member Enrollment consensus process, in which Standard developed by the NCPDP. use only the standards specified in representatives of health care providers, ii. Recommended Standard. health plans, and health care § 142.1402 for electronic health care The ANSI ASC X12 834—Benefit claims status transactions. clearinghouses participate. Enrollment and Maintenance is the 3. It is consistent with the other X12 ii. Health care clearinghouses. standard proposed for electronic We would require in § 142.1406 that standards detailed in this proposed rule. exchange of individual, subscriber, and each health care clearinghouse use the 4. Its development costs are relatively dependent enrollment and maintenance standards specified in § 142.1402 for low, given the ASC X12 development information between sponsors and health care claims status. process; its implementation costs would health plans, either directly or through iii. Health care providers. be relatively low as it can be In § 142.1408, Requirements: Health a vendor, such as a health care implemented along with a suite of X12 care providers, we would require each clearinghouse. In some instances, this transaction sets, often with a single health care provider that transmits transaction may be used also to translator. health care claim status requests exchange enrollment and maintenance 5. It was developed and will be electronically to use standards specified information between sponsors and maintained by the ANSI-accredited in § 142.1402 for those transactions. health care providers or between health standards setting organization ASC X12. plans and health care providers. 6. It is ready for implementation, with c. Implementation Guide and Source The NCPDP standard, which was the official implementation guide to The implementation guide for the developed to enhance the enrollment which we refer in Addendum G to this standard is available at no cost from the verification process for pharmaceutical proposed rule. Washington Publishing Company site at claims, rather than for transmitting 7. It was designed to be technology the following Internet address: http:// information between health plan and neutral by ASC X12. www.wpc-edi.com/hipaa/. The data sponsor, is not being proposed for 8. Precise and unambiguous definitions and description of data adoption in this rule. The NCPDP definitions for each data element in the conditions may also be obtained from standard pertains to these specific uses transaction set are documented in the this website. and is therefore not suitable in its implementation guides. Users without access to the Internet current form for the more general uses 9. The transaction is designed to keep may purchase implementation guides needed for the enrollment transaction. data collection requirements as low as is from Washington Publishing Company With the implementation of the ASC feasible. directly: Washington Publishing X12 834 for health care, sponsors would 10. All X12 transactions, including Company, 806 W. Diamond Ave., Suite be able to transmit information on the X12 834, are designed to make it 400, Gaithersburg, MD, 20878; enrollment and maintenance using a easy to accommodate constantly telephone 301–590–9337; FAX: 301– single, electronic format; health plans changing business requirements through 869-9460. would be required to accept only the flexible data architecture and coding standard transaction; neither sponsors systems. 5. Standard: Enrollment and nor health plans would have to continue iii. Uses of the ANSI ASC X12 834. Disenrollment in a Health Plan (Subpart to maintain and use multiple Transaction data elements in the O) proprietary formats or resort to paper. implementation guide for the ASC X12 [Please label any written comments or e- Adoption of this standard would 834 are defined as either required or mailed comments about this section with the benefit sponsors, especially, by conditional, where the conditions are subject: Enrollment] providing them the ability to convert to clearly stated. This transaction would be electronic transmission formats where used to enroll and disenroll not only the a. Background paper is still being used today. Many of subscriber, but also any covered Currently, employers and other these sponsors already use X12 dependents. In some instances, this sponsors conduct transactions with standards in their core business would be an enhancement to enrollment health plans to enroll and disenroll activities (for example, purchasing) information maintained by sponsors or subscribers and other individuals in a unrelated to the provision of health care health plans, compared with the health insurance plan. The transactions benefits to employees. The utility of this common practice today of maintaining are rarely done electronically. particular standard for health care detailed records on the subscriber alone. However, the ASC X12 834, Benefit transactions would be synergistic when In an increasingly value-conscious Enrollment and Maintenance has been considered in combination with the health care environment, detailed in widespread use within the insurance other standards in this proposed rule information on subscribers and covered industry at large since February 1992 (for example, ASC X12 820) and other dependents is necessary for the effective when ANSI approved it as a draft rules (PAYERID, national provider management of their health care standard for trial use. Variants of this identifier) promulgated under HIPAA. utilization. transaction standard have been widely In addition to being the only relevant Administrative and financial health used by employers to advise insurance standard for the enrollment and care transactions such as the ASC X12 companies of enrollment and maintenance process designed for use 834 enrollment transaction may have Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules 25293 other, secondary uses that may be to claims and encounter data in this health insurance coverage but also what important to consider as well. For regard. specific benefits are included in that example, secondary uses of health care The data elements for this transaction, coverage. Having such information claims data are common and include and other information, may be found in helps the health care provider to collect analyses of health care utilization, Addendum 5. correct patient deductibles, co- quality, and cost. The ASC X12 834 b. Requirement insurance amounts, and co-payments enrollment transaction has been and to provide an accurate bill for the discussed (for example, by the NCVHS) In § 142.1502, we would specify the patient and all pertinent health plans, as a means to collect demographic ASC X12 834 Benefit Enrollment and including secondary payers. information on individuals for use by Maintenance (004010X095) as the In addition, simple economics public health, State data organizations, standard for enrollment and dictates that the out-of-pocket cost to and researchers. Typically, demographic disenrollment transactions. We would the patient may affect treatment choices. data elements would be used in also specify the source of the The best case is when there are two combination with information obtained implementation guide and incorporate it equally effective treatment options and from other health care transactions, by reference. coverage is only available for one. More such as health care claims and i. Health plans. often, the question may be whether a equivalent encounter transactions, and In § 142.1504, Requirements: Health particular treatment is covered or not. from other sources. plans, we would require health plans to Here is an example: Jane Doe has cancer Proponents of this approach and these use only the standard specified in and a bone marrow transplant is the uses have expressed their beliefs that § 142.1502 for electronic enrollment and treatment of last resort. Since insurance the enrollment transaction includes disenrollment transactions. coverage does not extend to patient demographic data elements and ii. Health care clearinghouses. ‘‘experimental therapies,’’ the question We would require in § 142.1506 that that this would provide more reliable becomes: Does Jane’s insurance cover a each health care clearinghouse use the data on patient demographics than are bone marrow transplant for her standard specified in § 142.1502 for available currently from health care diagnosis? If she has leukemia, the enrollment and disenrollment claims and encounter databases. treatment may be covered; if she has transactions. Proponents also believe that the cervical cancer, it may not be. Whether iii. Sponsors. availability of demographic information There would be no requirement for Jane could afford to pay out-of-pocket is in jeopardy because the X12 837 sponsors to use the standard: they are for such a treatment could affect her health care claim transaction proposed not one of the entities subject to the treatment choice. The value of eligibility information is elsewhere in this rule includes minimal requirements of HIPAA. However, to the enhanced if it can be acquired quickly. patient demographic data elements. The extent a sponsor uses an electronic Traditional methods of communication use of this standard would be a change standard, it would benefit that sponsor from current practice in many States (that is, by phone or mail) are highly to use the standard we adopt for the where the health care claim is the inefficient. Patients and health plans reasons discussed earlier. In addition, vehicle for collecting such information. find it disturbing when the deductible HIPAA contains no provisions that Some proponents also have indicated a and co-pays are not correctly applied. would prohibit a health plan requiring desire to expand the number of When insurance inquiries of this sort sponsors with which its conducts demographic data elements contained in are transmitted electronically, health transactions electronically to use the the ASC X12 834 enrollment transaction care providers can receive the adopted standard. to serve these secondary uses. information from the health plan almost Opponents of this approach argue that c. Implementation Guide and Source immediately. However, in current practice, each health plan may require the ASC X12 834 enrollment transaction The implementation guide for the that the health care provider’s request is not a suitable vehicle for collecting ASC X12N 834 (004010X095) is be in a preferred format, which often demographic information for these available at no cost from the does not match the format required by secondary purposes. They also assert Washington Publishing Company site that such information would never be any other health plan. This means that on the World Wide Web at the following available on the uninsured and, since the health care provider must maintain address: http://www.wpc-edi.com/ there is no obligation on the part of the hardware and software capability to hipaa/. The data definitions and sponsors to adopt the electronic send multiple inquiry formats and description of data conditions may also transactions, would be only receive multiple response formats. be obtained from this website. intermittently available on the insured. Users without access to the Internet Because of this situation, adoption of They also state that, although some may purchase implementation guides electronic methods for inquiries has demographic elements are already from Washington Publishing Company been inhibited, and reliance on paper contained in the ASC X12 834 directly. Washington Publishing forms or the telephone for such enrollment transaction, no business Company, 806 W. Diamond Ave., Suite inquiries has continued. need has been identified that would 400, Gaithersburg, MD, 20878; support the addition of other such data i. Candidates for the Standard telephone 301–590–9337; FAX: 301– elements. Finally, the opponents argue The HISB developed an inventory of 869–9460. that secondary uses, while legitimate, health care information standards to be should not be allowed to subvert the 6. Standard: Eligibility for a Health Plan considered by the Secretary of HHS in primary purposes of these transactions (Subpart P) the adoption of standards. The ANSI ASC X12N 270—Health Care Eligibility nor the goal of administrative [Please label any written comments or e- simplification. mailed comments about this section with the Benefit Inquiry and companion 271— We welcome comments on the subject: Eligibility] Health Care Eligibility Benefit Response, practical utility of the ASC X12 834 the ASC X12N Interactive Health Care enrollment transaction as a vehicle for a. Background Eligibility/Benefit Inquiry (IHCEBI) and collecting demographic information on Often, health care providers may need its companion the Interactive Health individuals and its value as an adjunct to verify not only that a patient has Care Eligibility/Benefit Response 25294 Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules

(IHCEBR), the NCPDP standard at this time. Thus, the IHCEBI/ health plan), maximum benefits (policy Telecommunications Standard Format, IHCEBR would require higher limits), exclusions, in-plan/out-of-plan and the NCPDP Telecommunication additional development and benefits, coordination of benefits Claim Standard for Pharmaceutical implementation costs (criteria #4), and information, deductibles, and Professional Services are the standards they would not be consistent or uniform copayments. Specific requests might available for the electronic exchange of with the other standards selected include procedure coverage dates; patient eligibility and coverage (criteria #3). procedure coverage maximum; amounts information. If an interactive eligibility transaction for deductible, co-insurance, co- standard were ratified by an accredited ii. Recommended Standard payment, or patient responsibility; standards setting organization sometime coverage limitations; and noncovered We propose to adopt the ANSI ASC in the future, then it could be amounts. X12N 270—Health Care Eligibility considered for adoption as a HIPAA Another part of the ASC X12N 271 is Benefit Inquiry and the companion ASC standard. However, at this time, we designed to handle requests for X12N 271—Health Care Eligibility expect that any future standard for an eligibility ‘‘rosters,’’ which are Benefit Response as the standard for the interactive eligibility transaction is essentially lists of entities—subscribers eligibility for a health plan transaction. likely to differ substantially from the and dependents, health care providers, When evaluated against the criteria current IHCEBI/IHCEBR and the time to employer groups, health plans—and (discussed earlier) for choosing a readiness could be substantial as well their relationships to each other. For national standard, the ASC X12 # (criteria 6). example, this transaction might be used Transaction Sets 270/271 met the The goal of administrative by a health plan to submit a roster of criteria more often than did the ASC simplification, as expressed in the law, patients to a health care provider to X12 interactive or the NCPDP is to improve the efficiency and designate a primary care physician or to transactions. The ASC X12N 270/271 effectiveness of the health care system alert a hospital about forthcoming transaction set is supported by an # (criteria 1). Whereas it might seem that admissions. We are not recommending accredited standards setting the interactive message would yield this use of the ASC X12N 270/271 at organization ASC X12 (criteria #5). By greater efficiencies in terms of time this time because the roster comparison with the alternatives, the saved, similar efficiencies are available implementation guide is not ASC X12N 270/271 would have with the ASC X12N 270/271. In fact, the millennium compliant and the relatively low additional development ASC X12N 270 can be used to submit standards development process for the and implementation costs and would be a single eligibility inquiry electronically implementation guide is not completed. consistent with other standards in this for a very quick turnaround 271 After the standards development proposed rule (criteria #4 and #3). The response. Response times, measured in process for the roster implementation NCPDP standards, because they are seconds, would compare favorably to a guide is completed, it may be specific to pharmacy transactions, were true ‘‘interactive’’ transaction and considered for adoption as a national rejected because they would not meet would be a substantial improvement standard. the needs of the rest of the health care over telephone inquiries or paper system (criteria #2), whereas the ASC methods of eligibility determination. The data elements for this transaction, X12N 270/271 would. Transactions concerning eligibility for and other information, may be found in The X12N subcommittee and its a health plan would be used only to Addendum 6. Workgroup 1, which is responsible for verify the patient’s eligibility and b. Requirements the eligibility transaction, recommended benefits; they would not provide a in June 1997 that the ASC X12N 270/ history of benefit use. The electronic i. Health plans. 271 be adopted as the HIPAA standard exchange using these standards would In § 142.1604, Requirements: Health (criteria #5). occur usually between health care plans, we would require health plans to There are specific, technical reasons providers and health plans, but the use only the standard specified in against adoption of the IHCEBI/IHCEBR standard would support electronic § 142.1602 for electronic eligibility at this time. The IHCEBI/IHCEBR is inquiry and response among other transactions. based on UNEDIFACT, not ASC X12N, entities. In addition to uses by various ii. Health care clearinghouses. syntax. Because of concurrent changes health care providers (for example, We would require in § 142.1606 that in UNEDIFACT design rules, the hospitals, laboratories, and physicians), each health care clearinghouse use the IHCEBI/IHCEBR is not a complete or the ASC X12N 270/271 can be used by standard specified in § 142.1602 for consistent standard. It has not been an insurance company, a health eligibility transactions. classified by UNEDIFACT as ready to maintenance organization, a preferred iii. Health care providers. implement. In X12N, the current version provider organization, a health care In § 142.1608, Requirements: Health of IHCEBI/IHCEBR is 3070, and we purchaser, a professional review care providers, we would require each believe that current use is centered on organization, a third-party health care provider that transmits any a prior version (3051), which is not administrator, vendors (for example, health plan eligibility transactions millennium compliant. The IHCEBI/ billing services), service bureaus (such electronically to use the standard IHCEBR transaction is not ready to be as value-added networks), and specified in § 142.1602 for those moved into version 4 (4010), as are the government agencies (Medicare, transactions. other transactions being recommended Medicaid, and CHAMPUS). in this proposed rule. We also believe The eligibility transaction is designed c. Implementation Guide and Source that current use is quite limited, and not to be used for simple status requests as The implementation guide is available consistent across users; in effect, current well as more complex requests that may for the ASC X12N 270/271 uses of this transaction have been be related to specific clinical (004010X092) at no cost from the implemented in proprietary format(s). procedures. General requests might Washington Publishing Company site For all these reasons, the ICHEBI/ include queries for: all benefits and on the World Wide Web at the following ICHEBR is neither technically ready nor coverage conditions, eligibility status address: http://www.wpc-edi.com/ stable and cannot be recommended as a (whether the patient is active in the hipaa/. The data definitions and Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules 25295 description of data conditions may also electronic transmission; neither intended to be used to carry enrollment be obtained from this website. sponsors nor health plans would have to or other eligibility information. Users without access to the Internet continue to maintain and use multiple The data elements for this transaction, may purchase implementation guides proprietary premium payment formats and other information, may be found in from Washington Publishing Company or resort to paper. Addendum 7. directly. Washington Publishing Although the premium order/ b. Requirements Company, 806 W. Diamond Ave., Suite remittance advice (ASC X12 820), used 400, Gaithersburg, MD, 20878; for health plan premium payments, can In § 142.1702, we would specify the telephone 301–590–9337; FAX: 301– be paired with the ASC X12N 811— following as the standard for health plan 869–9460. Consolidated Service Invoice/Statement, premium payment: ASC X12 820— which is used for health plan premium Payment Order/Remittance Advice 7. Standard: Health Plan Premium (004010X061). We would specify where Payment (Subpart Q) billing, our proposal and the focus of the statute is on a standard only for to find the implementation guide and [Please label any written comments or e- health plan premium payments. incorporate it by reference. i. Health plans. mailed comments about this section with the In addition to being the only relevant subject: Premium] In § 142.1704, Requirements: Health standard designed for use by sponsors, plans, we would require health plans to a. Background the ANSI ASC X12 820 met 9 of the 10 accept only the standard specified in Electronic payment methods have criteria deemed to be applicable in § 142.1702 for electronic health plan become commonplace for consumers evaluating this potential standard. It premium payments. who pay their monthly mortgage, would improve the efficiency of ii. Health care clearinghouses. power, or telephone bills electronically. premium payment transactions by We would require in § 142.1706 that Yet, electronic payment of health prescribing a single, standard format. It each health care clearinghouse use the insurance premiums by employers is was designed to meet the needs of standards specified in § 142.1702 for not common at all. health care providers, health plans, and health plan premium payment Adoption of a standard for electronic health care clearinghouses by virtue of transactions. payment of health plan premiums its development within the ASC X12 iii. Sponsors. would benefit employers and other consensus process, in which There would be no requirement for sponsors, especially, by providing the representatives of health care providers, sponsors to use the standard: they are opportunity to convert to a single health plans, and health care not one of the entities subject to the electronic transmission format where clearinghouses participate. It is requirements of HIPAA. However, to the paper forms and premium payment consistent with the other ASC X12 extent a sponsor uses an electronic formats may vary from health plan to standards detailed in this proposed rule. standard, it would benefit that sponsor health plan. Many of these sponsors Its development costs are relatively low, to use the standard we adopt for the already use X12 standards in their core given the X12 development process; its reasons discussed earlier. In addition, business activities (for example, implementation costs would be HIPAA contains no provisions that purchasing) unrelated to the provision relatively low as it can be implemented would prohibit a health plan requiring of health care benefits to employees. along with a suite of X12 transaction sponsors with which its conducts Federal and State governments when sets, often with a single translator. It transactions electronically to use the acting as employers and other was developed and will be maintained adopted standard. by the ANSI-accredited standards government agencies that transmit c. Implementation Guide and Source premium payments to outside setting organization X12. It is ready for The implementation guide for this organizations (for example, State implementation, with the official transaction is the ASC X12N 820— Medicaid agencies that pay premiums to implementation guide to which we refer Payroll Deducted and Other Group outside organizations such as managed in Addendum 7 to this proposed rule. Premium Payment for Insurance care organizations) would also benefit It was designed to be technology neutral by X12. Precise and unambiguous Products (004010X061). from these electronic transactions. The implementation guide is available i. Candidates for Standard. definitions for each data element in the According to the inventory conducted transaction set are documented in the at no cost from the Washington for HHS by the HISB, only one standard implementation guides. Publishing Company site on the World developed and maintained by a The ANSI ASC X12 820—Payment Wide Web at the following address: standards developing organization for Order/Remittance Advice is currently http://www.wpc-edi.com/hipaa/. Users without access to the Internet health plan premium payment used in applications other than health may purchase implementation guides transaction exists. It is the ASC X12 care. However, it is currently not in from Washington Publishing Company 820—Payment Order/Remittance widespread use in the health insurance directly. Washington Publishing Advice. industry because most health plan Company, 806 W. Diamond Ave., Suite ii. Recommended Standard. premium payments are not done The standard we are proposing to electronically. However, some large 400, Gaithersburg, MD, 20878; adopt for health plan premium payment organizations are using the ASC X12 telephone 301–590–9337; FAX: 301– transactions is the ASC X12 820— 820 to meet other business 869–9460. Payment Order/Remittance Advice. If requirements, such as automated 8. Standard: Referral Certification and we adopt the ASC X12 820, health plans purchasing. The ASC X12 820 is used in Authorization (Subpart R) would be able to transmit premium the health care industry for premium [Please label any written comments or e- payments either as a summary payment payment information exchanged mailed comments about this section with the or with individual payment detail, or as between the sponsor and the health subject: Referral] payment amount and adjustment plan; it should not be confused with the amount, using a single, electronic ASC X12 834, which includes a. Background format. Health plans would be required additional nonpremium payment Increasingly, the delivery of health to accept the standard transaction as the information. The ASC X12 820 is not care is focused on achieving greater 25296 Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules value from each health care dollar, and industry representatives in a consensus care insurance industry. Upon rigorous monitoring of health care process taking into account business investigation, we found that the utilization has become a common needs. Further, the standard is fully property and casualty insurance method adopted by health plans for compatible with the other ASC X12 industry, among whose lines of business achieving their value goals. Traditional standards and can be translated to and is workers compensation insurance, had methods of communication between from native application systems using developed a standard transaction health care providers and health plans off-the-shelf software (commonly entitled ‘‘Report of Injury, Illness or or their designates, which rely on a referred to as ‘‘translators’’) that is Incident’’ (ASC X12N 148). This combination of paper forms and readily available and used by all transaction set was developed within telephone calls, are neither efficient nor industries utilizing ASC X12 standards. ASC X12N to encompass more than 30 cost effective and may impede the The data elements for this transaction, functions and exchanges that occur delivery of care. The burden and and other information, may be found in among the numerous parties to a inefficiencies of these communications Addendum 8. workers compensation claim. The could be reduced by the adoption of b. Requirements transaction can be used by an employer, standardized and electronic methods for first, to report an employee injury or making the requests and receiving In § 142.1802, we would specify the illness to the State government agency responses. following as the standard for referral that administers workers compensation i. Candidates for Standard. certifications and authorizations: ASC and, second, to report to the employer’s According to the inventory of X12N 278—Request for Review and workers compensation insurance carrier standards produced by the HISB for Response (004010X094). We would so that a claim can be established to HHS, there is only one standard specify where to find the cover the employee’s losses (income, available for referral certification and implementation guide and incorporate it health care, disability). When the authority. It is the ASC X12N 278, by reference. employer is the Federal government, the Health Care Services Review i. Health plans. transaction is used to report to the Information. In § 142.1804, Requirements: Health Department of Labor’s Office of Workers ii. Recommended Standard. plans, we would require health plans to Compensation Programs. In a few States, The ANSI ASC X12N 278—Health accept and transmit only the standard the transaction can also be used by Care Services Review Information is the specified in § 142.1802 for electronic health care providers to report an standard proposed for electronic referral certifications and employee’s work-related injury to exchange of requests and responses authorizations. employers and/or the employer’s between health care providers and ii. Health care clearinghouses. workers compensation insurance We would require in § 142.1806 that review organizations. carrier. The transaction can be used by each health care clearinghouse use the These exchanges of information can State agencies responsible for standard specified in § 142.1802 for be initiated by either the health care monitoring the disposition of a workers provider or the health plan. The health referral certifications and compensation claim. Other uses include care provider requests from a designated authorizations. summary reporting of employee injuries iii. Health care providers. review entity authorization or and illness to State workers certification for a patient to receive a In § 142.1808, Requirements: Health care providers, we would require each compensation boards, commissions, or particular health care service. In turn, agencies; the Federal Bureau of Labor the review entity receives and responds health care provider that transmits referral certifications and authorizations Statistics; the Federal Occupational to the health care provider’s request. In Safety and Health Administration; and electronically to use the standard addition to direct electronic inquiry and the Federal Environmental Protection specified in § 142.1802 for the response, the ASC X12N 278 can be Agency. transactions. used in connection with point of service The current, approved version of this terminals. c. Implementation Guide and Source transaction is 3070, which is not Many different types of organizations The implementation guide for the millennium compliant. There is no may act as a review entity in such an ASC X12N 278 (004010X094) is approved implementation guide for exchange. These include health plans, available at no cost from the version 4010, which would be insurance companies, health Washington Publishing Company site millennium compliant. The ASC X12N maintenance organizations, preferred on the World Wide Web at the following workgroup is developing a version 4010 provider organizations, health care address: http://www.wpc-edi.com/ or higher implementation guide and purchasers, managed care organizations hipaa/. data dictionary. The workgroup hopes providing coverage to Medicare and Users without access to the Internet to secure ASC X12N approval for its Medicaid beneficiaries, professional may purchase implementation guides revised standard and implementation review organizations, other health care from Washington Publishing Company guide in the spring of 1998. Current providers, and benefit management directly. Washington Publishing workgroup planning is for a single organizations, to name a few. Company, 806 W. Diamond Ave., Suite implementation guide that covers all of These requests and responses may 400, Gaithersburg, MD, 20878; the business uses to which we refer pertain to many different health care telephone 301–590–9337; FAX: 301– above. events, including reviews for: treatment 869–9460. Recommendation: authorization, specialty referrals, pre- We do not recommend that the ASC admission certifications, certifications 9. Standard: First Report of Injury X12N 148—Report of Injury, Illness or for health care services (such as home [Please label any written comments or e- Incident be adopted at this time, for the health and ambulance), extension of mailed comments about this section with the following reasons: certifications, and certification appeals. subject: Injury] a. There is no millennium-compliant As with all the other ASC X12 version of an implementation guide for transactions being proposed in this rule, Background this transaction. the ASC X12N 278 was developed with ‘‘First report of injury’’ is not a b. There is no complete data widespread input from health care general term or transaction in the health dictionary for this transaction. Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules 25297

c. The implementation guide under d. Is this a format developed, set testing will also be posted to a development covers more business maintained, or modified by a standard website. This website will be advertised requirements and functions than the setting organization as specified in on the HCFA home page. ‘‘first report of injury’’ specified in the Section 1171 (8) or does it meet the Level 2—Validation Testing—This is statute. exceptions specified in Section 1172 testing of sample transactions to see d. Consultation with the transaction’s (c)(2) of the Act? whether they are being written extensive user community is necessary We do not recommend that the correctly. We expect that private to establish a consensus regarding the IAIABC format be adopted at this time. industry will provide commercial scope of the transaction set, and this is We have asked that the IAIABC provide testing at this level. This level of testing not possible in the time available to the documentation for their format. would give the participants a sense of Secretary for promulgating a final In view of these facts, HHS will take whether they are meeting technical regulation. the following actions with regard to specifications of structure and syntax e. An alternative to the ASC X12N 148 adopting a standard for ‘‘first report of for a transaction, but it may not has been brought to our attention and injury’’: necessarily test for valid data. This type must be evaluated. a. Continue to monitor the progress of of testing would inform individuals that The alternative EDI format is that the ASC X12N subcommittee toward the transaction probably meets the developed and maintained by the development of a final, complete, specifications. These edits would be less International Association of Industrial millennium-compliant standard, rigorous than those that might be Accident Boards and Commissions implementation guide, and data applied by a health plan before payment (IAIABC). The IAIABC EDI format was dictionary for this transaction. (in the case of a claim) or by a health not identified in the ANSI HISB b. Request that ASC X12N review the care provider prior to posting (in the inventory of standards developed for ASC X12N 148 to determine whether all case of a health care claim payment/ HHS because the IAIABC is not an of its broad functionality should be advice). The test conditions and results ANSI-accredited standards setting included in a standard to be adopted from this level are generally shared only organization. under HIPAA authority or whether the between the parties involved. Under the law, a standard adopted scope of the transaction should be Level 3—Production Testing—This under the administrative simplification limited by dividing the functions into tests a transaction from a sender through provisions of HIPAA is required to be ‘‘a separate implementation guides. the receiver’s system. The test standard that has been developed, c. Review and evaluate information is exposed to all of the adopted, or modified by a standard documentation from the IAIABC on its edits, lookups, and checks that the setting organization’’ (section 1172(c) of format so that it can be evaluated transaction would undergo in a the Act) (if a standard exists). The according to the ten criteria used to production situation. The test Secretary may adopt a different standard evaluate candidate standards and in conditions and results from this level if it would substantially reduce relation to the ASC X12N 148 as are generally shared only between the administrative costs to health care described above. parties involved. providers and health plans when d. After the ASC X12N subcommittee Pilot production—Billions of dollars compared to the alternatives (section has completed its standard setting role change hands each year as a result of 1172(c)(2)(A)). and approved a 4010 version or higher health care claims processing alone. For Accordingly, the IAIABC EDI format implementation guide and data that reason, we believe the industry must be evaluated before a national definitions for the ASC X12N 148 and should sponsor pilot production standard for first report of injury after analysis of the IAIABC alternative projects to test transaction standards transactions is adopted because it is standard, issue a subsequent proposed that are not currently in full production reported to be widely used. The IAIABC rule promulgating a standard for ‘‘first prior to the effective date for adoption. will be requested to submit report of injury’’. Pilot production tests are not necessary documentation so that its first report of for the NCPDP retail pharmacy claim injury format can be evaluated III. Implementation of the Transaction since it is already in widespread use. On according to the ten criteria applied to Standards and Code Sets the other hand, some of the ASC X12N all other standards. A. Compliance Testing implementations have not yet been In assessing the utility of this placed in general production. We We have identified three levels of alternative standard, we will follow the believe that pilot production results testing that must be addressed in Guiding Principles for selecting a should be posted on a website and show connection with the adoption and standard to evaluate the IAIABC EDI information of general interest to implementation of the standards we are format against that developed and potential users. The information given is proposing and their required code sets: maintained by ANSI ASC X12N. The at the discretion of the entities Level 1—Developmental Testing— following questions about the IAIABC conducting the pilot and might contain This is the testing done by the standards standard will be of particular information regarding the number of setting organization during the importance: claims processed, the identity of the a. To what extent is this format development process. The conditions entities participating in the pilot, and widely accepted and used by for, and results of, this testing are made the name, telephone number or e-mail organizations performing these public by the relevant standards bodies, address of an individual willing to transactions? and are available at the following answer questions from the public. b. Is this format millennium- Internet web site: It would be useful to all participants compliant? http://www.disa.org if pilot production projects and the c. Does this standard meet the The information on the web site is results were posted to a web site for all requirements set forth in the provided at the discretion of the transactions. For the claim and Administrative Simplification standards setting organization and equivalent encounter transactions, we provisions of HIPAA for improving the could, among other things, refer to pilot, believe that posting pilot production efficiency and effectiveness of the limited, or large-scale production if projects and results to a web site must health care system? appropriate. Information regarding code be mandatory. 25298 Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules

B. Enforcement submit its waiver request to an HHS B. Revised Standards Failure to comply with standards may evaluation committee (not currently We recognize the very significant well result in monetary penalties. The established or defined). The contributions that the traditional Secretary is required by statute to organization must do the following for content committees (the NUCC, the impose penalties of not more than $100 each standard it wishes to replace: NUBC, the ADA, and the National per violation on any person who fails to + Provide a detailed explanation, no Council for Prescription Drug Programs) comply with a standard, except that the more than 10 pages in length, of how have made to health care transaction total amount imposed on any one the replacement would be a clear content over the years and, in particular, person in each calendar year may not improvement over the current standard the work they contributed to the content exceed $25,000 for violations of one in terms of the principles listed in of the standards proposed in this requirement. section I.D., Process for developing proposed rule. Other Federal and We are not proposing any national standards, of this preamble. private entities (the National Center for enforcement procedures at this time, but + Provide specifications and Health Statistics, the Health Care we will do so in a future Federal technical capabilities on the new Financing Administration, the AMA, Regulations document, once the standard, including any additional and the ADA) have developed and industry has some experience with system requirements. maintained the medical data code sets using the standards. + Provide an explanation, no more proposed as standards in this proposed We are at this time, however, than 5 pages in length, of how the rule. In a letter dated June 10, 1997, soliciting input on appropriate organization intends to test the WEDI recommended that the NUBC, mechanisms to permit independent standard, including the number and NUCC and ADA be recognized as the assessment of compliance. We are types of health care plans and health appropriate organizations to specify particularly interested in input from care providers expected to be involved data content. We expect that these those engaging in health care EDI as in the test, geographical areas, and current committees would continue to well as from independent certification beginning and end dates of the test. play an important role in maintenance and auditing organizations addressing • The committee’s evaluation would, of data content for standard health care issues of documentary evidence of steps at a minimum, be based on the transactions. The organizations assigned taken for compliance; need for/ following: responsibility for maintenance of data desirability of independent verification, + A cost-benefit analysis. content for standard health care validation, and testing of systems transactions will work with X12N data changes; and certifications required for + An assessment of whether the proposed replacement demonstrates a maintenance committees, ensuring that off-the-shelf products used to meet the implementation documentation is requirements of this regulation. clear improvement to an existing standard. updated in a consistent and timely IV. New and Revised Standards fashion. + The extent and length of time of the We intend that the private sector, A. New Standards waiver. with public sector involvement, • To encourage innovation and promote The evaluation committee would continue to have responsibility for development, we intend to develop a inform the organization requesting the defining the data element content of the process that would allow an waiver within 30 working days of the administrative transactions. Both organization to request a replacement to committee’s decision on the waiver Federal agencies and private any adopted standard or standards. request. If the committee decides to organizations will continue to be An organization could request a grant a waiver, the notification may responsible for maintaining medical replacement to an adopted standard by include the following: data code sets. The current data content requesting a waiver from the Secretary + Committee comments such as the committees are focused on transactions of HHS to test a new standard. The following: that involve health care providers and organization, at a minimum, must —The length of time for which the health plans. There may be some demonstrate that the new standard waiver applies if it differs from the organizations that represent employers clearly offers an improvement over the waiver request. or other sponsors and health plans and adopted standard. If the organization —The sites the committee believes are are interested in assuming the burden of presents sufficient documentation that appropriate for testing if they differ from maintenance of the data content supports testing of a new standard, we the waiver request. standards for the X12 820 and 834. We propose to designate content want to be able to grant the organization —Any pertinent information committees in the final rule and to a temporary waiver to test it while regarding the conditions of an approved specify the ongoing activities of these remaining in compliance with the law. waiver. content committees pertaining to the We do not intend to establish a process • that would allow organizations to Any organization that receives a data maintenance of all X12N standards request waivers as a tool to avoid using waiver would be required to submit a identified in this rule, as well as any adopted standard. report containing the results of the attachments. All approved changes, not We would welcome comments on the study, no later than 3 months after the including medical code sets, would following: (1) How we should establish study is completed. need to fit into the appropriate ASC this process, (2) the length of time a • The committee would evaluate the X12N implementation guide(s) and proposed standard should be tested report and determine whether the receive ASC X12N approval, with the before we decide whether to adopt it, proposed new standard meets the 10 exception of the NCPDP standard. The and (3) other issues and guiding principles and whether the NCPDP would continue to operate as recommendations we should consider advantages of a new standard would currently for data content. in developing this process. significantly outweigh the It is important that data content Following is one possible process: disadvantages of implementing it and revisions be made timely in this new • Any organization that wishes to make a recommendation to the standards environment. The Secretary of replace an adopted standard must Secretary. HHS may not revise any standard more Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules 25299 frequently than once a year and must + Annual public meeting schedules V. Collection of Information permit no fewer than 180 days for are posted on a website not later than Requirements implementation for all participants after 90 days after the effective date of the adopting a revised standard. New values final rule, and annually on that date Under the Paperwork Reduction Act could be added to the code sets for thereafter. of 1995 (PRA), we are required to certain data elements in transaction + The data maintenance body provide 60-day notice in the Federal standards more frequently than once a establishes a central contact (name and Register and solicit public comment year. For example, alpha-numeric post office and e-mail addresses) to before a collection of information HCPCS and NDC, two of the proposed which the public could submit requirement is submitted to the Office of standard code sets for medical data, correspondence (such as agenda items Management and Budget (OMB) for now have mechanisms for ongoing or data requests). review and approval. In order to fairly evaluate whether an information addition to new codes as needed to + During these two open meetings, collection should be approved by OMB, reflect new health services and new the public has the opportunity to voice section 3506(c)(2)(A) of the Paperwork drugs. Such ongoing update concerns and suggest changes. Reduction Act of 1995 requires that we mechanisms would continue to be + Each data maintenance body drafts solicit comment on the following issues: needed in the year 2000 and beyond. procedures for the public to follow in • The private sector organizations regard to its meeting protocols. The need for the information charged with data element content • Each data maintenance body drafts collection and its usefulness in carrying maintenance would have to ensure that procedures for the public to submit out the proper functions of our agency. the revised standard contains the most requests for data or for revisions to the • The accuracy of our estimate of the recent data maintenance items that have standard. These draft procedures are information collection burden. been brought to them and that those easy to use and are adequately • The quality, utility, and clarity of new data requirements are adequately communicated to the public. the information to be collected. • documented and communicated to the Each designated data maintenance • Recommendations to minimize the public. We believe that, at minimum, body is also responsible for information collection burden on the the data maintenance documentation communicating actions taken on affected public, including automated needs to include the data name, data requests to the requestor and the public, collection techniques. definition, the status of the data name in addition to communicating any (that is, required or conditional), written Subpart K—Health Claims or Equivalent changes made to a standard. This may Encounter Information Standard conditions regarding the circumstances be done via mail, e-mail, publications, under which the data would have to be or newsletters but, at a minimum, are 142.1104 Requirements: Health plans. supplied, a rationale for the new or 142.1108 Requirements: Health care published on the website. (We believe providers. revised data item, and its placement in the Internet is the most cost effective an implementation guide. We believe way of communicating this type of Subpart L—Health Care Payment and Remittance Advice that any data request approved by a information.) body three or more months prior to the • Each data maintenance body 142.1204 Requirements: Health plans. adoption of a new or revised standard responds definitively to each request it Subpart M—Coordination of Benefits would have to be included in that new receives no later than three months after 142.1304 Requirements: Health plans. standard implementation, assuming that the request is received. Subpart N—Health Claims Status no major format restructuring would An alternative approach would be to have to be done. (A new data element, 142.1404 Requirements: Health plans. require an organization which desired to 142.1408 Requirements: Health care code, or segment would not constitute be designated by the Secretary as the providers. major restructuring.) official data content maintenance body Subpart O—Enrollment and Disenrollment in We believe that any body with for a particular transaction to meet the a Health Plan responsibility for maintaining a ANSI criteria for due process found at standard under this proposed rule must http://www.ansi.org/procl1.html. Not 142.1504 Requirements: Health plans. allow public access to their decision only would these criteria meet the Subpart P—Eligibility for a Health Plan making processes. We plan to engage intent of HIPAA to advocate an open, 142.1604 Requirements: Health plans. standards setting organizations and balanced, consensus process, but once 142.1608 Requirements: Health care other organizations responsible for an organization met these criteria, it providers. maintenance of data element content would be able to apply for ANSI Subpart Q—Health Plan Premium Payments and standard code sets to establish a accreditation if it so desired. 142.1704 Requirements: Health plans. process that will enable timely It is not our intention to increase any Subpart R—Referral Certification and standards development/updates with current burdens on data maintenance Authorization appropriate industry input. One bodies. Our concern is that the public 142.1804 Requirements: Health plans. approach may be as follows: have a voice in the data maintenance • 142.1808 Requirements: Health care Each of the data maintenance process and that changes to a standard providers. bodies has biannual meetings with the be timely and adequately communicated public welcome to attend and to the industry. We welcome any Discussion: In summary, each of the participate without payment of fees. comments regarding the approach sections identified above require health + These public meetings are outlined above and recommendations care plans, and/or health care providers announced to the broadest possible for data maintenance committees for to use any given standard proposed in audience, at minimum by means of a each X12N transaction standard this regulation for all electronically website. The announcements of the identified in this rule. transmitted standard transactions that meetings may also be available via We also solicit comments on the require it on and after the effective date widely read publications, such as the appropriateness of ongoing Federal given to it. Commerce Business Daily or the Federal oversight/monitoring of maintenance The emerging and increasing use of Register. processes and procedures. health care EDI standards and 25300 Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules transactions raises the issue of the individually. We will consider all Paperwork Reduction Act of 1995. In applicability of the PRA. The question comments we receive by the date and order to be designated as a standard, a arises whether a regulation that adopts time specified in the DATES section of proposed standard should: an EDI standard used to exchange this preamble, and, if we proceed with • Improve the efficiency and certain information constitutes an a subsequent document, we will effectiveness of the health care system information collection subject to the respond to comments in the preamble to by leading to cost reductions for or PRA. However, for the purpose of that document. improvements in benefits from soliciting useful public comment we electronic HIPAA health care VII. Impact Analysis provide the following burden estimates. transactions. This principle supports the In particular, the initial burden on the As the effect of any one standard is regulatory goals of cost-effectiveness estimated 4 million health plans and 1.2 affected by the implementation of other and avoidance of burden. million health care providers to modify standards, it can be misleading to • Meet the needs of the health data their current computer systems software discuss the impact of one standard by standards user community, particularly would be 10 hours/$300 per entity, for itself. Therefore, we did an impact health care providers, health plans, and a total burden of 52 million hours/$1.56 analysis on the total effect of all the health care clearinghouses. This billion. While this burden estimate may standards in the proposed rule principle supports the regulatory goal of appear low, on average, we believe it to concerning the national provider cost-effectiveness. be accurate. This is based on the identifier (HCFA–0045–P), which can be • Be consistent and uniform with the assumption that these and the other found elsewhere in this Federal other HIPAA standards (that is, their burden calculations associated with the Register. data element definitions and codes and HIPAA administrative simplification We intend to publish in each their privacy and security requirements) systems modifications may overlap. proposed rule an impact analysis that is and, secondarily, with other private and This average also takes into specific to the standard or standards public sector health data standards. This consideration that: (1) One or more of proposed in that rule, but the impact principle supports the regulatory goals these standards may not be used; (2) analysis will assess only the relative of consistency and avoidance of some of the these standards may already cost impact of implementing a given incompatibility, and it establishes a be in use by several of the estimated standard. Thus, the following performance objective for the standard. entities; (3) modifications may be discussion contains the impact analysis • Have low additional development performed in an aggregate manner for each of the transactions proposed in and implementation costs relative to the during the course of routine business this rule. As stated in the general impact benefits of using the standard. This and/or; (4) modifications may be made analysis in HCFA–0045–P, we do not principle supports the regulatory goals by contractors such as practice intend to associate costs and savings to of cost-effectiveness and avoidance of management vendors, in a single effort specific standards. burden. for a multitude of affected entities. Although we cannot determine the • Be supported by an ANSI- We solicit comment on whether the specific economic impact of the accredited standards developing requirements to which we refer above standards being proposed in this rule organization or other private or public constitute a one-time or an ongoing, (and individually each standard may organization that would ensure usual and customary business practice not have a significant impact), the continuity and efficient updating of the as defined 5 CFR 1320.3(b)(2), the overall impact analysis makes clear that, standard over time. This principle Paperwork Reduction regulations. collectively, all the standards will have supports the regulatory goal of We invite public comment on the a significant impact of over $100 million predictability. issues discussed above. If you comment on the economy. Also, while each • Have timely development, testing, on these information collection and standard may not have a significant implementation, and updating recordkeeping requirements, please e- impact on a substantial number of small procedures to achieve administrative mail comments to [email protected] entities, the combined effects of all the simplification benefits faster. This (Attn:HCFA–0149) or mail copies proposed standards may have a principle establishes a performance directly to the following: significant effect on a substantial objective for the standard. Health Care Financing Administration, number of small entities. Therefore, the • Be technologically independent of Office of Information Services, following impact analysis should be the computer platforms and Information Technology Investment read in conjunction with the overall transmission protocols used in HIPAA Management Group, Division of impact analysis. health transactions, except when they HCFA Enterprise Standards, Room In accordance with the provisions of are explicitly part of the standard. This C2–26–17, 7500 Security Boulevard, Executive Order 12866, this proposed principle establishes a performance Baltimore, MD 21244–1850. Attn: rule was reviewed by the Office of objective for the standard and supports John Burke HCFA–0149 Management and Budget. the regulatory goal of flexibility. • Be precise and unambiguous but as and Guiding Principles for Standard Office of Information and Regulatory simple as possible. This principle Selection Affairs, Office of Management and supports the regulatory goals of Budget, Room 10235, New Executive The implementation teams charged predictability and simplicity. Office Building, Washington, DC with designating standards under the • Keep data collection and paperwork 20503, Attn: Allison Herron Eydt, statute have defined, with significant burdens on users as low as is feasible. HCFA Desk Officer. input from the health care industry, a This principle supports the regulatory set of common criteria for evaluating goals of cost-effectiveness and VI. Response to Comments potential standards. These criteria are avoidance of duplication and burden. Because of the large number of items based on direct specifications in the • Incorporate flexibility to adapt more of correspondence we normally receive HIPAA, the purpose of the law, and easily to changes in the health care on Federal Register documents principles that support the regulatory infrastructure (such as new services, published for comment, we are not able philosophy set forth in Executive Order organizations, and provider types) and to acknowledge or respond to them 12866 of September 30, 1993, and the information technology. This principle Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules 25301 supports the regulatory goals of process assures, that it will be number.) Some of these differences flexibility and encouragement of compatible with the commercial, off- reflect variations in covered services innovation. the-shelf translator programs that are that will continue to exist irrespective of widely available in the United States. General data standardization. Others reflect These translators significantly reduce differences in a health plan’s ability to The effect of implementing standards the cost and complexity of achieving accept as valid a claim that may include on health care clearinghouses is and maintaining compliance with all more information than is needed or basically the same for all the standards. ASC X12 standards. Universal used by that health plan. The Currently, health care clearinghouses communication with all parties in the requirement to use standard coding receive and transmit various health care industry is thus assured. guidelines will eliminate this latter transactions using a variety of formats. Specific technology limitations of category of differences and should The implementation of standard existing systems could affect the simplify claims submission for health transactions may reduce the variability complexity of conversion. Also, some care providers that deal with multiple in the data received from some groups, existing health care provider systems health plans. such as health care providers. The may not have the resources to house a implementation of any standard will translator to convert from one format to Currently, there are health plans that require some one-time changes to health another. do not adhere to official coding care clearinghouse systems. Health care Following is the portion of the impact guidelines and have developed their clearinghouses should be able to make analysis that relates specifically to the own plan-specific guidelines for use modifications that meet the deadlines standards that are the subject of this with the standard code sets, which do specified in the legislation, but some regulation. not permit the use of all valid codes. temporary disruption of processing (Again, we cannot quantify how many could result. Once the transition is A. Code Sets—Specific Impact of health plans do this, but we are aware made, health care clearinghouses may Adoption of Code Sets for Medical Data of some instances.) When the HIPAA have less ongoing system maintenance. Affected Entities code set standards become effective, Costs may vary according to the these health plans would have to complexity of the standard, but costs Standard codes and classifications are receive and process all standard codes, may be recouped from customers. required in some segments of irrespective of local policies regarding Health care clearinghouses would face administrative and financial reimbursement for certain conditions or impacts (both positive and negative) transactions. Those that create and procedures, coverage policies, or need process administrative transactions similar to those experienced by health for certain types of information that are must implement the standard codes plans (which we discuss in more detail part of a standard transaction. in the discussions for specific according to the official implementation transactions). However, implementation guides designated for each coding We believe that there is significant would likely be more complex, because system and each transaction. Those that variation in the reporting of anesthesia health care clearinghouses deal with receive standard electronic services, with some health plans using many health care providers and health administrative transactions must be able the anesthesia section of CPT and others plans and may have to accommodate to receive and process all standard requiring the anesthesiologist or nurse additional nonstandard formats (in codes (and modifiers, in the cases of anesthetist to report the code for the addition to those formats they currently HCPCS and CPT), irrespective of local surgical procedure itself. When the support), as well as standards we adopt. policies regarding reimbursement for HIPAA code sets become effective, (The additional nonstandard formats certain conditions or procedures, health plans following the latter would be from those health care coverage policies, or need for certain convention will have to begin accepting providers that choose to stop submitting types of information that are part of a codes from the anesthesia section. standard transaction. directly to an insurer and submit We note that by adopting standards through a health care clearinghouse.) The adoption of standard code sets for code sets we are requiring that all and coding guidelines for medical data This would also mean increased parties accept these codes within their supports the regulatory goals of cost- business for the health care electronic transactions. We are not effectiveness and the avoidance of clearinghouse. requiring payment for all these services. duplication and burden. The code sets Converting to any standard will result Those health plans that do not adhere in one-time conversion costs for health that are being proposed as initial HIPAA to official coding guidelines must care providers, health care standards are all de facto standards therefore undertake a one-time effort to clearinghouses, and health plans as already in use by most health plans, modify their systems to accept all valid well. Some health care providers and health care clearinghouses, and health codes in the standard code sets or health plans would incur those costs care providers. engage a health care clearinghouse to directly and others may incur them in Health care providers currently use preprocess the standard claims data for the form of a fee from health care the recommended code set for reporting them. Health plans should be able to clearinghouses or, for health care diagnoses and one or more of the make modifications to meet the providers, other agents. recommended procedure coding deadlines specified in the legislation, Each standard compares favorably systems for reporting procedures/ but some temporary disruption of with typical ASC X12 standards in services. Since health plans can differ terms of complexity and ease of use. No on the codes they accept, many health claims processing could result. one in the ASC X12 subcommittee care providers use different coding There may be some temporary assumes that every entity that sends or guidelines for dealing with different disruption of claims processing as receives an ASC X12 transaction has health plans, sometimes for the same health plans and health care reprogrammed its information systems patient. (Anecdotal information leads us clearinghouses modify their systems to in order to do so. Every transaction is to believe that use of other codes is accept all valid codes in the standard designed, and the technical review widespread, but we cannot quantify the code sets. 25302 Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules

B. Transaction Standards upgrades for some smaller health care Since the majority of dental claims are providers, health plans, and health care submitted on paper and those submitted 1. Specific Impact of Adoption of the clearinghouses may be cost prohibitive. electronically are being transmitted National Council of Prescription Drug Health care providers and health plans using a variety of proprietary formats, Programs (NCPDP) Telecommunication have the option of using a the only viable choice of a standard is Claim clearinghouse. the ASC X12N 837. The American a. Affected Entities The cost may also cause some smaller Dental Association (ADA) also Health care providers that submit health plans that have trading partner recommended the ASC X12N 837 for retail pharmacy claims, and health care agreements today to discontinue that the dental claim standard. plans that process retail pharmacy partnership. That same audience of The ASC X12N 837 was selected as claims, currently use the NCPDP format. health care providers, health care the standard for the professional The NCPDP claim and equivalent clearinghouses, and health plans could (physician/supplier) claim because it encounter is used either in on-line conceivably be forced out of the met the principles above. The only other partnerships of transmitting and interactive or batch mode. Since all candidate standard, the National accepting claims data. In these instances pharmacy health care providers and Standard Format, was developed patients may be affected, in that, health plans use the NCPDP claim primarily by HCFA for Medicare claims. without trading partner agreements for format, there are no specific impacts to While it is widely used, it is not always electronic crossover of claims data for health care providers. used in a standard manner. Many the processing of the supplemental variations of the National Standard b. Effects of Various Options benefit, the patient may be responsible Format are in use. The NUCC, the AMA, The NCPDP format met all the for filing his or her own supplemental and WEDI recommended the ASC X12N principles and there are no known claims that are filed electronically 837 for the professional claim standard. options for a standard retail pharmacy today. The ASC X12N 837 was selected as claim transaction. Coordination of Benefits the standard for the institutional (hospital) claim because it met the 2. Specific Impact of Adoption of the Once the ASC X12N 837 has been principles above. The only other ASC X12N 837 for Submission of implemented, health plans that perform candidate standard is the UB–92 Institutional Health Care Claims, coordination of benefits would be able Format. While it is widely used, it is not Professional Health Care Claims, Dental to eliminate support of multiple always used in a standard manner. Claims, and Coordination of Benefits proprietary electronic claim formats, The selection of the ASC X12N 837 a. Affected Entities thus simplifying claims receipt and does not impose a greater burden on the processing as well as reducing industry than the nonselected options All health care providers and health administrative costs. Coordination of plans that conduct EDI directly and use because the nonselected formats are not benefits activities would also be greatly used in a standard manner by the other electronic format(s), and all health simplified because all health plans care providers that decide to change industry and they do not incorporate would use the same standard format. flexibility in order to adapt easily to from a paper format to an electronic There is no doubt that standardization change. The ASC X12N 837 presents one, would have to begin to use the ASC in coordination of benefits will greatly significant advantages in terms of X12N 837 for submitting electronic enhance and improve efficiency in the universality and flexibility. health care claims (hospital, physician/ overall claims process and the supplier and dental). (Currently, about 3 coordination of benefits. 3. Specific Impact of Adoption of the percent of Medicare providers use this From a nonsystems perspective, we ASC X12N 835 for Receipt of Health standard for claims; it is used less for do not foresee an impact to the Care Remittance non-Medicare claims.) coordination of benefits process. The a. Affected Entities There would be a potential for COB transaction will continue to consist disruption of claims processes and of the incoming electronic claim and the Health care providers that conduct timely payments during a particular data elements provided on a remittance EDI with health plans and do not wish health plan’s transition to the ASC advice. Standardization in the to change their internal systems would X12N 837. Some health care providers coordination of benefits process will have to convert the ASC X12N 835 could react adversely to the increased clearly increase efficiency in the transactions received from health plans cost and revert to submitting hard copy electronic processes utilized by the into a format compatible with their claims. health care providers, health care internal systems. Health plans that want After implementation, health care clearinghouses, and health plans as they to transmit remittance advice directly to providers would no longer have to keep work with standardized codes and health care providers and that do not track of and use different electronic processes. use the ASC X12N 835 would also incur formats for different insurers. This costs to convert. Many health care would simplify provider billing systems b. Effects of Various Options providers and health plans do not use and processes and reduce We assessed the various options for a this standard at this time. (We do not administrative expenses. standard claim transaction against the have information to quantify the Health plans would be able to principles, listed at the beginning of this standard’s use outside the Medicare schedule their implementation of the impact analysis above, with the overall program. However, in 1996, 15.9 ASC X12N 837 in a manner that best fits goal of achieving the maximum benefit percent of part B health care providers their needs, thus allaying some costs for the least cost. We found that the ASC and 99.4 percent of part A health care (through coordination of conversion to X12N 837 for institutional claims, providers were able to receive this other standards) as long as they meet the professional claims, dental claims, and standard. All Medicare contractors must deadlines specified in the legislation. coordination of benefits met all the be able to send the standard.) Although the costs of implementing the principles, but no other candidate There would be a potential for the ASC X12N 837 are generally one-time standard transaction met all the delay in payment or the issuance of costs related to conversion, the systems principles. electronic remittance advice Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules 25303 transactions during a particular health transactions, it was not developed for forms. (We cannot quantify how many plan’s transition to the ASC X12N 835. health care payment purposes. The ASC of these sponsors use paper forms, but Some health care providers could react X12N subcommittee itself recognized anecdotal information indicates that adversely to the increased cost and this in its decision to develop the ASC most use paper.) We understand that revert to use of hard copy remittance X12N 835. large employers and other sponsors are advice notices in lieu of an electronic more likely to conduct subscriber transmission. 4. Specific Impact of Adoption of the enrollment transactions electronically After implementation, health care ASC X12N 276/277 for Health Care because of the many changes that occur providers would no longer have to keep Claim Status/Response in a large workforce; for example, track of or accept different electronic a. Affected Entities hirings, firings, retirements, marriages, payment/remittance advice formats Most health care providers that are births, and deaths, to name a few. To do issued by different health care payers. currently using an electronic format (of this, the large employers must use the This would simplify automatic posting which there are currently very few) and proprietary electronic data interchange of all electronic payment/remittance that wish to request claim status formats that differ among health plans. advice data, reducing administrative electronically using the ASC X12N 276/ Nonetheless, it is our understanding, expenses. This would also reduce or 277 will incur conversion costs. We based on anecdotal information, that eliminate the practice of posting cannot quantify the number of health health plans still use paper to conduct payment/remittance advice data care providers that would have to most of their enrollment transactions. manually from hard copy notices, again We expect that the impact of the ASC convert to the proposed standard, but reducing administrative expenses. Most X12N 834 transaction standard would we do know that no Medicare manual posting occurs currently in differ, at least in the beginning, contractors use it; thus, we assume that response to the problem of multiple according to the current use of few health care providers are able to use formats, which the standard would electronic transactions. As stated earlier, it at this time. eliminate. most small and medium size employers After implementation, health care Once the ASC X12N 835 has been and other sponsors do not use electronic providers would be able to request and implemented, health plans’ transactions currently and would receive the status of claims in one coordination of benefits activities, therefore experience little immediate standard format, from all health care which would use the ASC X12N 837 impact from adoption of the ASC X12N format supplemented with limited data plans. This would eliminate their need 834 transaction. The ASC X12N 834 from the ASC X12N 835, would be to maintain redundant software and would offer large employers that greatly simplified because all health would make electronic claim status currently conduct enrollment plans would use the same standard requests and receipt of responses transactions electronically the format. feasible for small providers, eliminating opportunity to shift to a single standard Health plans would be able to their need to manually send and review format. A single standard will be most schedule their implementation of the claim status requests and responses. attractive to those large employers that ASC X12N 835 in a manner that best fits Health care plans that do not offer their subscribers choices among their needs, thus allaying some costs currently directly accept electronic multiple health plans. Thus, we expect (through coordination of conversion to claim status requests and do not directly that the early benefits of the ASC X12N other standards), as long as they meet send electronic claims status responses 834 would accrue to large employers the deadlines specified in the would have to modify their systems to and other sponsors that would be able legislation. accept the ASC X12N 276 and to send to eliminate redundant hardware, The selection of the ASC X12N 835 the ASC X12N 277. No disruptions in software, and human resources required does not impose a greater burden on the claims processing or payment would to support multiple proprietary industry than the nonselected option occur. electronic data interchange formats. In because the nonselected formats are not After implementation, health care the long run, we expect that the used in a standard manner by the plans would be able to submit claim standards would lower the cost of industry and they do not incorporate status responses in one standard format conducting enrollment transactions and flexibility in order to adapt easily to to all health care providers. make it possible for small and medium change. The ASC X12N 835 presents Administrative costs incurred by size companies to convert from paper to significant advantages in terms of supporting multiple formats and electronic transactions and achieve universality and flexibility. manually responding to claim status significant additional savings. requests would be greatly reduced. Overall, employers and other b. Effects of Various Options b. Effects of Various Options sponsors, and the health plans with We assessed the various options for a which they deal, stand to benefit from standard payment/remittance advice There are no known options for a adoption of the ASC X12N 834 and transaction against the principles listed standard claims status and response electronic data interchange. The ASC above, with the overall goal of achieving transaction. X12N 834 and electronic data the maximum benefit for the least cost. 5. Specific Impact of Adoption of the interchange would facilitate the We found that the ASC X12N 835 met ASC X12N 834 for Enrollment and performance of enrollment and all the principles, but no other Disenrollment in a Health Plan disenrollment functions. Further, the candidate standard transaction met all ASC X12N 834 supports detailed the principles, or even those principles a. Affected Entities enrollment information on the supporting the regulatory goal of cost- The ASC X12N 834 may be used by subscriber’s dependents, which is often effectiveness. an employer or other sponsor to lacking in current practice. Ultimately, The ASC X12N 835 was selected as it electronically enroll or disenroll its reductions in administrative overhead met the principles above. The only other subscribers into or out of a health plan. may be passed along in lower premiums candidate standard, the ASC X12N 820, Currently, most small and medium size to subscribers and their dependents. was not selected because, although it employers and other sponsors conduct We invite commenters to provide us was developed for payment their subscriber enrollments using paper with data on the extent to which 25304 Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules employers and other sponsors conduct IHCEBR, and the NCPDP At some point, an organization’s size their health plan enrollments using Telecommunications Standard Format. and complexity will require it to paper proprietary formats rather than None of these meet the selection criteria consider switching its business the ASC X12N 834 electronic data and thus they would not be transactions from paper to electronic. interchange standards. implementable. The ASC X12N 820 would facilitate that by eliminating redundant proprietary b. Effects of Various Options 7. Specific Impact of Adoption of the formats that are certain to crop up when ASC X12N 820 for Payroll Deducted and The only other option, the NCPDP there are no widely accepted standards. Other Group Premium Payment for Member Enrollment Standard, does not By eliminating the software, hardware, Insurance Product meet the selection criteria and would and human resources associated with not be implementable. a. Affected Entities redundancy, a business may reach the 6. Specific Impact of Adoption of the The ASC X12N 820 may be used by point where it becomes cost beneficial ASC X12N 270/271 for Eligibility for a an employer or sponsor to electronically to convert from paper to electronic Health Plan transmit a remittance notice to transactions. Those other sponsors and health care plans that already support a. Affected Entities accompany a payment for health insurance premiums in response to a more than one proprietary format would The ASC X12N 270/271 transaction bill from the health plan. Payment may incur some additional expense in the may be used by a health care provider be in the form of a paper check or an conversion to the standard, but they to electronically request and receive electronic funds transfer transaction. would enjoy longer term savings that eligibility information from a health The ASC X12N 820 can be sent with result from eliminating the care plan prior to providing or billing electronic funds transfer instructions redundancies. for a health care service. Many health that are routed directly to the Federal We invite comments on the extent to care providers routinely verify health Reserve System’s automated health care which employers and other sponsors insurance coverage and benefit clearinghouses or with payments conduct their health plan premium limitations prior to providing treatment generated directly by the employer’s or payments using paper versus or before preparing claims for other sponsor’s bank. The ASC X12 820 proprietary formats, compared to the submission to the insured patient and transaction is very widely used by many ASC X12N 820 electronic data his or her health plan. Currently, health industries (manufacturing, for instance) interchange standards. care providers secure most of these and government agencies (Department eligibility determinations through b. Effects of Various Options of Defense) in addition to the insurance telephone calls, proprietary point of sale industry in general. However, the ASC There are no known options for terminals, or using proprietary X12N 820 is not widely used in the premium payment transactions. electronic formats that differ from health insurance industry and is not health plan to health plan. Since many 8. Specific Impact of Adoption of ASC widely used by employers and other health care providers participate in X12N 278 for Referral Certification and sponsors to make premium payments to multiple health plans, these health care Authorization their health insurers. This may be due, providers must maintain redundant a. Affected Entities software, hardware, and human in part, to the lack of an implementation The ASC X12N 278 may be used by resources to obtain eligibility guide specifically for health insurance. Currently, most payment transactions a health care provider to request and information. This process is inefficient, are conducted on paper, and those that receive approval from a health plan often burdensome, and takes valuable time that could otherwise be devoted to are conducted electronically use through an electronic transaction prior patient care. proprietary electronic data interchange to providing a health care service. Prior We believe that the lack of a health standards that differ across health plans. approvals have become standard care industry standard may have (We cannot quantify how many of these operating procedure for most hospitals, imposed a cost barrier to the widespread transactions are conducted on paper, physicians and other health care use of electronic data interchange. The but anecdotal information suggests that providers due to the rapid growth of ASC X12N 270/271 is used widely, but most are.) We believe that the lack of a managed care. Health care providers not exclusively, by health care plans health care industry standard may have secure most of their prior approvals and health care providers. This may be imposed a cost barrier to the use of through telephone calls, paper forms or due, in part, to the lack of an industry- electronic data interchange; larger proprietary electronic formats that differ wide implementation guide for these employers and other sponsors, that from health plan to health plan. Since transactions in health care. We expect often transact business with multiple many health care providers participate that adoption of the ASC X12N 270/271 health plans, need to retain redundant in multiple managed care plans, they and its implementation guide would hardware, software, and human must devote redundant software, lower the cost of using electronic resources to support multiple hardware, and human resources to eligibility verifications. This would proprietary electronic premium obtaining prior authorization. This benefit health care providers that can payment standards. We expect that process is often untimely and move to a single standard format and, adoption of national standards will inefficient. for the first time, make electronic data lower the cost of using electronic We believe that the lack of a health interchange feasible for small health premium payments. This will benefit care industry standard may have plans and health care providers that rely large employers that can move to a imposed a cost barrier to the widespread currently on the telephone, paper forms, single standard format, and, for the first use of electronic data interchange. The or proprietary point of sale terminals time, will make electronic transmissions ASC X12N 278 is not widely used by and software. of premium payments feasible for health care plans and health care smaller employers and other sponsors providers, which may be due, in part, to b. Effect of Various Options whose payment transactions today are the lack of an industry-wide There were two other options, the performed almost exclusively using implementation guide for it. We expect ASC X12N IHCEBI, and its companion, paper. that adoption of ASC X12N 278 and its Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules 25305 implementation guide would lower the 142.103 Definitions. Subpart PÐEligibility for a Health Plan cost of using electronic prior 142.104 General requirements for health 142.1602 Standard for eligibility for a authorizations. This would benefit plans. health plan. health care providers that can move to 142.105 Compliance using a health care 142.1604 Requirements: Health plans. a single standard format and, for the clearinghouse. 144.1606 Requirements: Health care first time, make electronic data 142.106 Effective dates of a modification to clearinghouses. a standard or implementation interchange feasible for smaller health 142.1608 Requirements: Health care specification. providers. plans and health care providers that 142.110 Availability of implementation 142.1610 Effective dates of the initial perform these transactions almost guides. implementation of the standard for exclusively using the telephone or eligibility for a health plan. paper. Subparts B±IÐ[Reserved] Subpart QÐHealth Plan Premium Payments At some point, an organization’s size Subpart JÐCode Sets and complexity will require it to 142.1702 Standard for health plan premium 142.1002 Medical data code sets. consider switching its business payments. 142.1004 Code sets for nonmedical data 142.1704 Requirements: Health plans. transactions from paper to electronic. elements. The ASC X12N 278 would facilitate that 144.1706 Requirements: Health care 142.1010 Effective dates of the initial clearinghouses. by eliminating redundant proprietary implementation of code sets. 142.1708 Effective dates of the initial formats that are certain to crop up when implementation of the standard for there are no widely accepted standards. Subpart KÐHealth Claims or Equivalent Encounter Information health plan premium payments. By eliminating the software, hardware, and human resources associated with 142.1102 Standards for health claims or Subpart RÐReferral Certification and Authorization redundancy, a business may reach the equivalent encounter information. point where it becomes cost beneficial 142.1104 Requirements: Health plans. 142.1802 Referral certification and 142.1106 Requirements: Health care to convert from paper to electronic authorization. clearinghouses. 142.1804 Requirements: Health plans. transactions. Health care plans and 142.1108 Requirements: Health care 144.1806 Requirements: Health care health care providers that already providers. clearinghouses. support more than one proprietary 142.1110 Effective dates of the initial 142.1808 Requirements: Health care format would incur some additional implementation of the health claim or providers. expense in the conversion to the equivalent encounter information. 142.1810 Effective dates of the initial standard but would enjoy longer term implementation of the standard for Subpart LÐHealth Claims and Remittance referral certifications and authorizations. savings that result from eliminating the Advice redundancies. Authority: Sections 1173 and 1175 of the 142.1202 Standard for health claims and Social Security Act (42 U.S.C. 1320d–2 and b. Effects of Various Options remittance advice. 1320d–4) There are no known options for 142.1204 Requirements: Health plans. 144.1206 Requirements: Health care Subpart AÐGeneral Provisions referral and certification authorization clearinghouses. transactions. 142.1210 Effective dates of the initial § 142.101 Statutory basis and purpose. implementation of the health claims and Sections 1171 through 1179 of the List of Subjects in 45 CFR Part 142 remittance advice. Social Security Act, as added by section Administrative practice and Subpart MÐCoordination of Benefits 262 of the Health Insurance Portability procedure, Health facilities, Health 142.1302 Standard for coordination of and Accountability Act of 1996, require insurance, Hospitals, Incorporation by HHS to adopt national standards for the reference, Medicare, Medicaid. benefits. 142.1304 Requirements: Health plans. electronic exchange of health Accordingly, 45 CFR subtitle A, 144.1306 Requirements: Health care information in the health information subchapter B, would be amended by clearinghouses. system. The purpose of these sections is adding Part 142 to read as follows: 142.1308 Effective dates of the initial to promote administrative Note to Reader: This proposed rule and implementation of the standard for simplification. another proposed rule found elsewhere in coordination of benefits. § 142.102 Applicability. this Federal Register are two of several Subpart NÐHealth Claim Status proposed rules that are being published to (a) The standards adopted or implement the administrative simplification 142.1402 Standard for health claim status. designated under this part apply, in provisions of the Health Insurance Portability 142.1404 Requirements: Health plans. whole or in part, to the following: and Accountability Act of 1996. We propose 144.1406 Requirements: Health care (1) A health plan. clearinghouses. to establish a new 45 CFR Part 142. Proposed (2) A health care clearinghouse when Subpart A—General Provisions is exactly the 142.1408 Requirements: Health care same in each rule unless we have added new providers. doing the following: sections or definitions to incorporate 142.1410 Effective dates of the initial (i) Transmitting a standard transaction additional general information. The subparts implementation of the standard for (as defined in § 142.103) to a health care that follow relate to the specific provisions health claims status. provider or health plan. announced separately in each proposed rule. (ii) Receiving a standard transaction When we publish the first final rule, each Subpart OÐEnrollment and Disenrollment in a Health Plan from a health care provider or health subsequent final rule will revise or add to the plan. text that is set out in the first final rule. 142.1502 Standard for enrollment and (iii) Transmitting and receiving the disenrollment in a health plan. standard transactions when interacting PART 142ÐADMINISTRATIVE 142.1504 Requirements: Health plans. REQUIREMENTS 144.1506 Requirements: Health care with another health care clearinghouse. clearinghouses. (3) A health care provider when Subpart AÐGeneral Provisions 142.1508 Effective dates of the initial transmitting an electronic transaction as Sec. implementation of the standard for defined in § 142.103. 142.101 Statutory basis and purpose. enrollment and disenrollment in a health (b) Means of compliance are stated in 142.102 Applicability. plan. greater detail in § 142.105. 25306 Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules

§ 142.103 Definitions. (as currently defined in section 3(l) of for the purpose of affecting any body For purposes of this part, the the Employee Retirement Income and structure or function of the body; following definitions apply: Security Act of 1974 (29 U.S.C. 1002(l)), amounts paid for transportation ASC X12 stands for the Accredited including insured and self-insured primarily for and essential to these Standards Committee chartered by the plans, to the extent that the plan items; and amounts paid for insurance American National Standards Institute provides medical care, including items covering the items and the to design national electronic standards and services paid for as medical care, to transportation specified in this for a wide range of business employees or their dependents directly definition. applications. or through insurance, or otherwise, and Participant means any employee or ASC X12N stands for the ASC X12 (i) Has 50 or more participants; or former employee of an employer, or any subcommittee chartered to develop (ii) Is administered by an entity other member or former member of an electronic standards specific to the than the employer that established and employee organization, who is or may insurance industry. maintains the plan. become eligible to receive a benefit of Code set means any set of codes used (2) Health insurance issuer. A health any type from an employee benefit plan for encoding data elements, such as insurance issuer is an insurance that covers employees of that employer tables of terms, medical concepts, company, insurance service, or or members of such an organization, or medical diagnostic codes, or medical insurance organization that is licensed whose beneficiaries may be eligible to procedure codes. to engage in the business of insurance receive any of these benefits. Health care clearinghouse means a in a State and is subject to State law that ‘‘Employee’’ includes an individual who public or private entity that processes or regulates insurance. is treated as an employee under section facilitates the processing of nonstandard (3) Health maintenance organization. 401(c)(1) of the Internal Revenue Code data elements of health information into A health maintenance organization is a of 1986 (26 U.S.C. 401(c)(1)). standard data elements. The entity Federally qualified health maintenance Small health plan means a group receives transactions from health care organization, an organization recognized health plan or individual health plan providers, health plans, other entities, as a health maintenance organization with fewer than 50 participants. or other clearinghouses, translates the under State law, or a similar Standard means a set of rules for a set data from a given format into one organization regulated for solvency of codes, data elements, transactions, or acceptable to the intended recipient, under State law in the same manner and identifiers promulgated either by an and forwards the processed transaction to the same extent as such a health organization accredited by the American to the appropriate recipient. Billing maintenance organization. National Standards Institute or HHS for services, repricing companies, (4) Part A or Part B of the Medicare the electronic transmission of health community health management program under title XVIII of the Social information. information systems, community health Security Act. Transaction means the exchange of information systems, and ‘‘value-added’’ (5) The Medicaid program under title information between two parties to networks and switches are considered to XIX of the Social Security Act. carry out financial and administrative be health care clearinghouses for (6) A Medicare supplemental policy activities related to health care. It purposes of this part. (as defined in section 1882(g)(1) of the includes the following: Health care provider means a Social Security Act). (1) Transactions specified in section provider of services as defined in (7) A long-term care policy, including 1173(a)(2) of the Act, which are as section 1861(u) of the Social Security a nursing home fixed-indemnity policy. follows: Act, a provider of medical or other (8) An employee welfare benefit plan (i) Health claims or equivalent health services as defined in section or any other arrangement that is encounter information. 1861(s) of the Social Security Act, and established or maintained for the (ii) Health care payment and any other person who furnishes or bills purpose of offering or providing health remittance advice. and is paid for health care services or benefits to the employees of two or more (iii) Health claims status. supplies in the normal course of employers. (iv) Enrollment and disenrollment in business. (9) The health care program for active a health plan. Health information means any military personnel under title 10 of the (v) Eligibility for a health plan. information, whether oral or recorded in United States Code. (vi) Health plan premium payments. any form or medium, that— (10) The veterans health care program (vii) First report of injury. (1) Is created or received by a health under 38 U.S.C., chapter 17. (viii) Referral certification and care provider, health plan, public health (11) The Civilian Health and Medical authorization. authority, employer, life insurer, school Program of the Uniformed Services (ix) Health claims attachments. or university, or health care (CHAMPUS), as defined in 10 U.S.C. (2) Other transactions as the Secretary clearinghouse; and 1072(4). may prescribe by regulation. (2) Relates to the past, present, or (12) The Indian Health Service Coordination of benefits is a transaction future physical or mental health or program under the Indian Health Care under this authority. condition of an individual, the Improvement Act (25 U.S.C. 1601 et provision of health care to an seq.). § 142.104 General requirements for health individual, or the past, present, or (13) The Federal Employees Health plans. future payment for the provision of Benefits Program under 5 U.S.C. chapter If a person conducts a transaction (as health care to an individual. 89. defined in § 142.103) with a health plan Health plan means an individual or (14) Any other individual or group as a standard transaction, the following group plan that provides, or pays the health plan, or combination thereof, that apply: cost of, medical care. Health plan provides or pays for the cost of medical (a) The health plan may not refuse to includes the following, singly or in care. conduct the transaction as standard combination: Medical care means the diagnosis, transaction. (1) Group health plan. A group health cure, mitigation, treatment, or (b) The health plan may not delay the plan is an employee welfare benefit plan prevention of disease, or amounts paid transaction or otherwise adversely Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules 25307 affect, or attempt to adversely affect, the at no cost, through the Washington Subpart KÐHealth Claims or person or the transaction on the basis Publishing Company on the Internet at Equivalent Encounter Information that the transaction is a standard http://www.wpc-edi.com/hipaa/. § 142.1102 Standards for health claims or transaction. (b) The implementation guide for (c) The health information transmitted equivalent encounter information. pharmacy claims may be obtained from and received in connection with the The health claims or equivalent the National Council for Prescription transaction must be in the form of encounter information standards that Drug Programs, 4201 North 24th Street, standard data elements of health must be used under this subpart are as Suite 365, Phoenix, AZ, 85016; information. follows: (d) A health plan that conducts telephone 602–957–9105; and FAX 602– (a) For pharmacy claims, the NCPDP transactions through an agent must 955–0749. It may also be obtained Telecommunications Standard Format assure that the agent meets all the through the Internet at http:// Version 3.2 and equivalent Standard requirements of this part that apply to www.ncpdp.org. Claims Billing Tape Format batch the health plan. (c) A copy of the guides may be implementation, version 2.0. The inspected at the Office of the Federal Director of the Federal Register § 142.105 Compliance using a health care approves this incorporation by reference clearinghouse. Register, 800 North Capitol Street, NW., Suite 700, Washington, DC and at the in accordance with 5 U.S.C. 552(a) and (a) Any person or other entity subject Health Care Financing Administration. 1 CFR part 51. The guide is available at to the requirements of this part may the addresses specified in § 142.108(b) meet the requirements to accept and Subparts B±IÐ[Reserved] and (c) of this part. transmit standard transactions by (b) The ASC X12N 837—Health Care either— Subpart JÐCode Sets Claim: Dental, Version 4010, (1) Transmitting and receiving Washington Publishing Company, standard data elements, or § 142.1002 Medical data code sets. 004010X097. The Director of the Federal (2) Submitting nonstandard data Register approves this incorporation by elements to a health care clearinghouse Health plans, health care reference in accordance with 5 U.S.C. for processing into standard data clearinghouses, and health care 552(a) and 1 CFR part 51. The guide is elements and transmission by the health providers must use on electronic available at the addresses specified in care clearinghouse and receiving transactions the diagnostic and § 142.108(a) and (c) of this part. standard data elements through the procedure code sets as prescribed by (c) The ASC X12N 837—Health Care health care clearinghouse. HHS. These code sets are published in Claim: Professional, Version 4010, (b) The transmission, under contract, a notice in the Federal Register. The Washington Publishing Company, of nonstandard data elements between a implementation guides for the 004010X098. The Director of the Federal health plan or a health care provider transaction standards in part 142, Register approves this incorporation by and its agent health care clearinghouse Subparts K through R specify which of reference in accordance with 5 U.S.C. is not a violation of the requirements of the standard medical data code sets are 552(a) and 1 CFR part 51. The guide is this part. to be used in individual data elements available at the addresses specified in within those transaction standards. § 142.106 Effective dates of a modification § 142.108(a) and (c) of this part. (d) The ASC X12N 837—Health Care to a standard or implementation § 142.1004 Code sets for nonmedical data specification. elements. Claim—Institutional, Version 4010, If HHS adopts a modification to a Washington Publishing Company, standard or implementation The code sets for nonmedical data 004010X096. The Director of the Federal specification, the implementation date that must be used in a transaction Register approves this incorporation by of the modified standard or specified in subparts K through R of this reference in accordance with 5 U.S.C. implementation specification may be no part are the code sets described in the 552(a) and 1 CFR part 51. The guide is earlier than 180 days following the implementation guide for the available at the addresses specified in adoption of the modification. HHS transaction standard. § 142.108(a) and (c) of this part. determines the actual date, taking into § 142.1010 Effective dates of the initial § 142.1104 Requirements: Health plans. account the time needed to comply due implementation of code sets. Each health plan must accept the to the nature and extent of the (a) Health plans. (1) Each health plan standard specified in § 142.1102 when modification. HHS may extend the time conducting transactions concerning for compliance for small health plans. that is not a small health plan must comply with the requirements of health claims and equivalent encounter § 142.110 Availability of implementation §§ 142.104, 142.1002, and 142.1004 by information. guides. (24 months after the effective date of the § 142.1106 Requirements: Health care The implementation guides specified final rule in the Federal Register). clearinghouses. in subparts K through R of this part are (2) Each small health plan must Each health care clearinghouse must available as set forth in paragraphs (a) comply with the requirements of use the standard specified in § 142.1102 through (c) of this section. Entities §§ 142.104, 142.1002, and 142.1004 by when accepting or transmitting health requesting copies or access for [36 months after the effective date of the claims or equivalent encounter inspection must specify the standard by final rule in the Federal Register]. information transactions. name, number, and version. (a) The implementation guides for (b) Health care clearinghouses and § 142.1108 Requirements: Health care ASC X12 standards may be obtained health care providers. Each health care providers. from the Washington Publishing clearinghouse and health care provider Any health care provider that Company, 806 W. Diamond Ave., Suite must begin to use the standards transmits health claims or equivalent 400, Gaithersburg, MD, 20878; specified in §§ 142.1002 and 142.1004 encounter information electronically telephone 301–590–9337; and FAX: by (24 months after the effective date of must use the standard specified in 301–869–9460. They are also available, the final rule in the Federal Register). § 142.1102. 25308 Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules

§ 142.1110 Effective dates of the initial by (24 months after the effective date of § 142.1308 Effective dates of the initial implementation of the health claim or the final rule in the Federal Register). implementation of the standard for equivalent encounter information standard. coordination of benefits. (a) Health plans. (1) Each health plan Subpart MÐCoordination of Benefits (a) Health plans. (1) Each health plan that is not a small health plan must that performs coordination of benefits comply with the requirements of § 142.1302 Standard for coordination of and is not a small health plan must §§ 142.104 and 142.1104 by (24 months benefits. comply with the requirements of after the effective date of the final rule The coordination of benefits §§ 142.104 and 142.1304 by (24 months in the Federal Register). information standards that must be used after the effective date of the final rule (2) Each small health plan must under this subpart are as follows: in the Federal Register). comply with the requirements of (2) Each small health plan that §§ 142.104 and 142.1104 by (36 months (a) For pharmacy claims, the NCPDP performs coordination of benefits must after the effective date of the final rule Telecommunications Standard Format comply with the requirements of in the Federal Register). Version 3.2 and equivalent Standard §§ 142.104 and 142.1304 by (36 months (b) Health care clearinghouses and Claims Billing Tape Format batch after the effective date of the final rule health care providers. Each health care implementation, version 2.0. The in the Federal Register). clearinghouse and health care provider Director of the Federal Register (b) Health care clearinghouses. Each must begin to use the standard specified approves this incorporation by reference health care clearinghouse must begin to in § 142.1102 by (24 months after the in accordance with 5 U.S.C. 552(a) and use the standard specified in § 142.1302 effective date of the final rule in the 1 CFR part 51. The guide is available at by (24 months after the effective date of Federal Register). the addresses specified in § 142.108(b) the final rule in the Federal Register). and (c) of this part. Subpart NÐHealth Claim Status Subpart LÐHealth Claims and (b) For dental claims, the ASC X12N Remittance Advice 837—Health Care Claim: Dental, § 142.1402 Standard for health claim status. § 142.1202 Standard for health claims and Version 4010, Washington Publishing remittance advice. Company, 004010X097. The Director of The standard for health claim status The standard for health claims and the Federal Register approves this that must be used under this subpart is remittance advice that must be used incorporation by reference in the ASC X12N 276/277 Health Care under this subpart is the ASC X12N accordance with 5 U.S.C. 552(a) and 1 Claim Status Request and Response, 835—Health Care Claim Payment/ CFR part 51. The guide is available at Version 4010, Washington Publishing Advice, Version 4010, Washington the addresses specified in § 142.108(a) Company, 004010X093. The Director of Publishing Company, 004010X091. The and (c) of this part. the Federal Register approves this Director of the Federal Register (c) For professional claims, the ASC incorporation by reference in approves this incorporation by reference X12N 837—Health Care Claim: accordance with 5 U.S.C. 552(a) and 1 in accordance with 5 U.S.C. 552(a) and Professional, Version 4010, Washington CFR part 51. The guide is available at the addresses specified in § 142.108(a) 1 CFR part 51. The guide is available at Publishing Company, 004010X098. The and (c) of this part. the addresses specified in § 142.108(a) Director of the Federal Register and (c) of this part. approves this incorporation by reference § 142.1404 Requirements: Health plans. in accordance with 5 U.S.C. 552(a) and § 142.1204 Requirements: Health plans. Each health plan must accept and 1 CFR part 51. The guide is available at Each health plan must transmit the transmit the standard specified in the addresses specified in § 142.108(a) § 142.1402 when accepting or standard specified in § 142.1202 when and (c) of this part. conducting health claims and transmitting health claim status in remittance advice transactions. (d) For institutional claims, the ASC transactions with health care providers. X12N 837—Health Care Claim— § 142.1406 Requirements: Health care § 142.1206 Requirements: Health care Institutional, Version 4010, Washington clearinghouses. clearinghouses. Publishing Company, 004010X096. The Each health care clearinghouse must Each health care clearinghouse must Director of the Federal Register use the standard specified in § 142.1402 use the standard specified in § 142.1202 approves this incorporation by reference when accepting or transmitting health when accepting or transmitting health in accordance with 5 U.S.C. 552(a) and claims status transactions. claims and remittance advice. 1 CFR part 51. The guide is available at the addresses specified in § 142.108(a) § 142.1408 Requirements: Health care § 142.1210 Effective dates of the initial providers. implementation of the health claims and and (c) of this part. remittance advice. Any health care provider that § 142.1304 Requirements: Health plans. transmits or accepts health claims status (a) Health plans. (1) Each health plan electronically must use the standard that is not a small health plan must Each health plan that performs specified in § 142.1402. comply with the requirements of coordination of benefits must accept §§ 142.104 and 142.1204 by (24 months and transmit the standard specified in § 142.1410 Effective dates of the initial after the effective date of the final rule § 142.1302 when accepting or implementation of the standard for health in the Federal Register). transmitting coordination of benefits claims status. (2) Each small health plan must transactions. (a) Health plans. (1) Each health plan comply with the requirements of § 142.1306 Requirements: Health care that is not a small health plan must §§ 142.104 and 142.1204 by (36 months clearinghouses. comply with the requirements of after the effective date of the final rule §§ 142.104 and 142.1404 by (24 months in the Federal Register). Each health care clearinghouse must after the effective date of the final rule (b) Health care clearinghouses. Each use the standard specified in § 142.1302 in the Federal Register). health care clearinghouse must begin to when accepting or transmitting (2) Each small health plan must use the standard specified in § 142.1204 coordination of benefits transactions. comply with the requirements of Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules 25309

§§ 142.104 and 142.1404 by (36 months used under this subpart is ASC X12N incorporation by reference in after the effective date of the final rule 270—Health Care Eligibility Benefit accordance with 5 U.S.C. 552(a) and 1 in the Federal Register). Inquiry and ASC X12N 271—Health CFR part 51. The guide is available at (b) Health care clearinghouses and Care Eligibility Benefit Response, [date], the addresses specified in § 142.108(a) health care providers. Each health care Version 4010, Washington Publishing and (c) of this part. clearinghouse and health care provider Company, (004010X092). The Director must begin to use the standard specified of the Federal Register approves this § 142.1704 Requirements: Health plans. in § 142.1402 by (24 months after the incorporation by reference in Each health plan must accept the effective date of the final rule in the accordance with 5 U.S.C. 552(a) and 1 standard specified in § 142.1702 when Federal Register). CFR part 51. The guide is available at accepting electronically transmitted the addresses specified in § 142.108(a) health plan premium payments. Subpart OÐEnrollment and and (c) of this part. Disenrollment in a Health Plan § 142.1706 Requirements: Health care § 142.1604 Requirements: Health plans. clearinghouses. § 142.1502 Standard for enrollment and Each health care clearinghouse must disenrollment in a health plan. Each health plan must accept and transmit the standard specified in use the standard specified in § 142.1702 The standard for enrollment and § 142.1602 when accepting or when accepting or transmitting health disenrollment in a health plan that must transmitting transactions for eligibility plan premium payments. be used under this subpart is the ASC for a health plan. X12 834—Benefit Enrollment and § 142.1708 Effective dates of the initial Maintenance, [date], Version 4010, § 142.1606 Requirements: Health care implementation of the standard for health Washington Publishing Company, clearinghouses. plan premium payments. (004010X095). The Director of the Each health care clearinghouse must (a) Health plans. (1) Each health plan Federal Register approves this use the standard specified in § 142.1602 that is not a small health plan must incorporation by reference in when accepting or transmitting comply with the requirements of accordance with 5 U.S.C. 552(a) and 1 transactions for eligibility for a health §§ 142.104 and 142.1704 by (24 months CFR part 51. The guide is available at plan. after the effective date of the final rule the addresses specified in § 142.110(a) in the Federal Register). and (c). § 142.1608 Requirements: Health care (2) Each small health plan must providers. comply with the requirements of § 142.1504 Requirements: Health plans. Any health care provider that §§ 142.104 and 142.1704 by (36 months Each health plan must accept the transmits or receives transactions for after the effective date of the final rule standard specified in § 142.1502 when eligibility for a health plan in the Federal Register). accepting transactions for enrollment electronically must use the standard (b) Health care clearinghouses. Each and disenrollment in a health plan. specified in § 142.1602. health care clearinghouse must begin to § 142.1506 Requirements: Health care the use the standard specified in § 142.1610 Effective dates of the initial § 142.1702 by (24 months after the clearinghouses. implementation of the standard for Each health care clearinghouse must eligibility for a health plan. effective date of the final rule in the Federal Register). use the standard specified in § 142.1502 (a) Health plans. (1) Each health plan when accepting or transmitting that is not a small health plan must Subpart RÐReferral Certification and transactions for enrollment and comply with the requirements of Authorization disenrollment in a health plan. §§ 142.104 and 142.1604 by (24 months after the effective date of the final rule § 142.1802 Referral certification and § 142.1508 Effective dates of the initial authorization. implementation of the standard for in the Federal Register). enrollment and disenrollment in a health (2) Each small health plan must The standard for referral certification plan. comply with the requirements of and authorization transactions that must (a) Health plans. (1) Each health plan §§ 142.104 and 142.1604 by (36 months be used under this subpart is the ASC that is not a small health plan must after the effective date of the final rule X12N 278—Request for Review and comply with the requirements of in the Federal Register). Response, (date), Version 4010, §§ 142.104 and 142.1504 by (24 months (b) Health care clearinghouses and Washington Publishing Company, after the effective date of the final rule health care providers. Each health care (004010X094). The Director of the in the Federal Register). clearinghouse and health care provider Federal Register approves this (2) Each small health plan must must begin to use the standard specified incorporation by reference in comply with the requirements of in § 142.1602 by (24 months after the accordance with 5 U.S.C. 552(a) and 1 §§ 142.104 and 142.1504 by (36 months effective date of the final rule in the CFR part 51. The guide is available at after the effective date of the final rule Federal Register). the addresses specified in § 142.108(a) in the Federal Register). and (c) of this part. Subpart QÐHealth Plan Premium (b) Health care clearinghouses. Each § 142.1804 Requirements: Health plans. health care clearinghouse must begin to Payments use the standard specified in § 142.1502 Each health plan must accept and § 142.1702 Standard for health plan transmit the standard specified in by (24 months after the effective date of premium payments. the final rule in the Federal Register). § 142.1802 when accepting or The standard for health plan premium transmitting referral certifications and Subpart PÐEligibility for a Health Plan payments that must be used under this authorizations. subpart is the ASC X12 820—Payment § 142.1602 Standard for eligibility for a Order/Remittance Advice, (date), § 142.1806 Requirements: Health care health plan. Version 4010, Washington Publishing clearinghouses. The standard for eligibility for a Company, (004010X061). The Director Each health care clearinghouse must health plan transaction that must be of the Federal Register approves this use the standard specified in § 142.1902 25310 Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules when accepting or transmitting referral Amt. Attrib. To Prod. Selection Other Payor Amount certifications and authorizations. Amt. Exceed. Periodic Benefit Max Patient City Address Authorization Number Patient First Name § 142.1808 Requirements: Health care Basis of Cost Determination Patient Last Name providers. Basis of Days Supply Determination Patient Paid Amount Any health care provider that Basis of Reimb. Determination Patient Pay Amount transmits or accepts referral Batch Number Patient Phone Number Bin Number Patient Social Security certifications and authorizations Cardholder First Name Patient State Address electronically must use the standard Cardholder Id Number Patient Street Address specified in § 142.1902. Cardholder Last Name Patient Zip Code Carrier Address Payment Processor Id § 142.1810 Effective dates of the initial Carrier Correction Notice Fields Person Code implementation of the standard for referral Carrier Identification Number Pharmacy Address certifications and authorizations. Carrier Location City Pharmacy Count (a) Health plans. (1) Each health plan Carrier Location State Pharmacy Location City that is not a small health plan must Carrier Name Pharmacy Location State comply with the requirements of Carrier Telephone Number Pharmacy Name §§ 142.104 and 142.1804 by (24 months Carrier Zip Code Pharmacy Number after the effective date of the final rule Claim Count Pharmacy Telephone Number in the Federal Register). Claim/reference Id Number Pharmacy Zip Code (2) Each small health plan must Clinic Id Number Plan Identification Co-pay Amount Postage Amount Claimed comply with the requirements of Comments-1 Postage Amount Paid §§ 142.104 and 142.1804 by (36 months Comments-2 Prescriber Id after the effective date of the final rule Compound Code Prescriber Last Name in the Federal Register). Contract Fee Paid Prescription Denial Clarification (b) Health care clearinghouses and Customer Location Prescription Number health care providers. Each health care Date Filled Prescription Origin Code clearinghouse and health care provider Date of Birth Primary Prescriber must begin to use the standard specified Date of Injury Prior Authorization/medical Certification in § 142.1802 by (24 months after the Date Prescription Written Code And Number Processor Address effective date of the final rule in the Days Supply Destination Name Processor Control Number Federal Register). Destination Processor Number Processor Location City Dated: March 27, 1998. Diagnosis Code Processor Location State Donna E. Shalala, Diskette Record Id Processor Name Processor Number Secretary. Dispense as Written (Daw) Dispensing Fee Submitted Processor Telephone Number Note: These Addenda will not appear in Dollar Count Processor Zip Code the Code of Federal Regulations. Dollars Adjusted Record Identifier Addendum 1—Health Claims or Equivalent Dollars Billed Reject Code Encounter Information Dollars Rejected Reject Count Drug Name Relationship Code A. Retail Drug Claim or Equivalent Encounter Drug Type Remaining Benefit Amount The transactions selected for retail drug Dur Conflict Code Remaining Deductible Amount claims are accredited by the American Dur Intervention Code Response Data National Standards Institute (ANSI). The Dur Outcome Code Response Status transactions are: NCPDP Dur Response Data Resubmission Cycle Count Telecommunications Standard Format Eligibility Clarification Code Run Date version 3.2 and the equivalent NCPDP Batch Employer City Address Sales Tax Paid Standard Version 1.0. Employer Contact Name Sales Tax Sex Code 1. Implementation Guide and Source Employer Name Employer Phone Number System Id The source of the implementation guide for Employer State Address Terminal Id the NCPDP Telecommunication Standard Employer Street Address Third Party Type Format Version 3.2 and the equivalent Employer Zip Code Total Amount Paid NCPDP Batch Standard Version 1.0 is the Fee or Markup Transaction Code National Council for Prescription Drug Gross Amount Due Unit Dose Indicator Programs, 4201 North 24th Street, Suite 365, Group Number Usual And Customary Charge Phoenix, AZ, 85016, Telephone 602–957– Home Plan Version Release Number 9105, FAX 602–955–0749. The web site Host Plan address is http://www.ncpdp.org B. Professional Health Claim or Equivalent Incentive Amount Submitted Encounter 2. Data Elements Incentive Fee Paid The transaction selected for the Accumulated Deductible Amount Ingredient Cost Billed professional (non-institutional) health claim Additional Message Information Ingredient Cost Paid or equivalent encounter information is ASC Adjustment/reject Code—1 Ingredient Cost X12N 837—Health Care Claim: Professional Adjustment/reject Code—2 Level of Service (004010X098) Adjustment/reject Code—3 Master Sequence Number Alternate Product Code Message 1. Implementation Guide and Source Alternate Product Type Metric Decimal Quantity The source of the implementation guide for Amount Attributed to Sales Tax Metric Quantity the professional health care claim or Amount Billed Ndc Number equivalent encounter is: Washington Amount of Co-pay/co-insurance New/refill Code Publishing Company, 806 W. Diamond Ave., Amount Rejected Number of Refills Authorized Suite 400, Gaithersburg, MD, 20878, Amt. Applied to Periodic Deduct Other Coverage Code Telephone 301–590–9337, FAX: 301–869– Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules 25311

9460. The web site address is http:// Country Code Hierarchical ID Number www.wpc-edi.com/hipaa/ Coverage Certification Period Count Hierarchical Level Code 2. Data Elements Creation Date Hierarchical Parent ID Number Credit or Debit Card Holder Additional Name Hierarchical Structure Code Accident Date Credit or Debit Card Holder First Name Homebound Indicator Acute Manifestation Date Credit or Debit Card Holder Last or Hospice Employed Provider Indicator Additional Submitter or Receiver Name Organizational Name HCPCS Payable Amount Adjudication or Payment Date Credit or Debit Card Holder Middle Name Identification Code Qualifier Adjusted Repriced Claim Reference Number Credit or Debit Card Holder Name Suffix Immunization Status Code Adjusted Repriced Line Item Reference Credit or Debit Card Maximum Amount Immunization Type Code Number Credit or Debit Card Number Independent Lab Charge Amount Adjustment Amount Credit/Debit Flag Code Individual Relationship Code Adjustment Quantity Currency Code Information Release Code Adjustment Reason Code Current Illness or Injury Date Information Release Date Agency Qualifier Code CHAMPUS Non-availability Indicator Ingredient Cost Claimed Amount Allowed Amount Daily Amino Acid Gram Use Count Initial Treatment Date Ambulatory Patient Group Number Daily Amino Acid Prescription Milliliter Use Insurance Type Code Amino Acid Name Count Insured Employer Additional Name Amount Qualifier Code Daily Dextrose Prescription Milliliter Use Insured Employer City Name Anesthesia or Oxygen Minute Count Count Insured Employer Contact Name Approved Ambulatory Patient Group Daily Prescribed Nutrient Calorie Count Insured Employer First Address Line Amount Daily Prescribed Product Calorie Count Insured Employer First Name Approved Ambulatory Patient Group Code Date of Surgical Procedure Insured Employer Identifier Approved Service Unit Count Date Time Period Format Qualifier Insured Employer Middle Name Arterial Blood Gas Quantity Date/Time Qualifier Insured Employer Name Suffix Arterial Blood Gas Test Date Deductible Amount Insured Employer Name Assigned Number Diagnosis Associated Amount Insured Employer Second Address Line Assumed or Relinquished Care Date Diagnosis Code Pointer Insured Employer State Code Attachment Control Number Diagnosis Code Insured Employer ZIP Code Attachment Description Text Disability Type Code Insured Group Name Attachment Report Type Code Disability-From Date Insured Group Number Attachment Transmission Code Disability-To Date Investigational Device Exemption Identifier Auto Accident State or Province Code Discipline Type Code Laboratory or Facility City Name Benefits Assignment Certification Indicator Drug Formulary Number Laboratory or Facility Contact Name Billing Provider Additional Name Drug Unit Price Laboratory or Facility First Address Line Billing Provider City Name Billing Provider Contact Name Emergency Indicator Laboratory or Facility Name Additional Text Billing Provider Credit Card Identifier Emergency Medical Technician (EMT) or Laboratory or Facility Name Billing Provider First Address Line Paramedic First Name Laboratory or Facility Postal ZIP or Zonal Billing Provider First Name Emergency Medical Technician or Paramedic Code Billing Provider Identifier Middle Name Laboratory or Facility Primary Identifier Billing Provider Last or Organizational Name Emergency Medical Technician or Paramedic Laboratory or Facility Second Address Line Billing Provider Middle Name City Name Laboratory or Facility Secondary Identifier Billing Provider Name Suffix Emergency Medical Technician or Paramedic Laboratory or Facility State or Province Code Billing Provider Postal Zone or ZIP Code First Address Line Last Certification Date Billing Provider Second Address Line Emergency Medical Technician or Paramedic Last Menstrual Period Date Billing Provider State or Province Code Last Name Last Seen Date Bundled or Unbundled Line Number Emergency Medical Technician or Paramedic Last Worked Date Certification Form Number Name Additional Text Last X-Ray Date Certification Period Projected Visit Count Emergency Medical Technician or Paramedic Legal Representative Additional Name Certified Registered Nurse Anesthetist Primary Identifier Legal Representative City Name Supervision Indicator Emergency Medical Technician or Paramedic Legal Representative First Address Line Claim Adjustment Group Code Second Address Line Legal Representative First Name Claim Encounter Identifier Emergency Medical Technician or Paramedic Legal Representative Last or Organization Claim Filing Indicator Code Secondary Identifier Name Claim Frequency Code Emergency Medical Technician or Paramedic Legal Representative Middle Name Claim Note Text State Code Legal Representative Second Address Line Claim Payment Remark Code Emergency Medical Technician or Paramedic Legal Representative State Code Claim Submission Reason Code ZIP Code Legal Representative Suffix Name Clinical Laboratory Improvement Employment Status Code Legal Representative ZIP Code Amendment Number End Stage Renal Disease Payment Amount Line Item Control Number Code Category Enteral or Parenteral Indicator Line Note Text Code List Qualifier Code Entity Identifier Code Mammography Certification Number Coinsurance Amount Entity Type Qualifier Measurement Qualifier Communication Number Qualifier Exception Code Measurement Reference Identification Code Communication Number Exchange Rate Medical Justification Text Complication Indicator Explanation of Benefits Indicator Medical Record Number Condition Codes EPSDT Indicator Medicare Assignment Code Condition Indicator Facility Type Code Medicare Coverage Indicator Contact Function Code Family Planning Indicator Multiple Procedure Indicator Contact Inquiry Reference Feeding Count National Drug Code Continuous Passive Motion Date File Creation Time National Drug Unit Count Contract Amount First Visit Date Nature of Condition Code Contract Code Fixed Format Information Non-Payable Professional Component Billed Contract Percentage Functional Status Code Amount Contract Type Code Group or Policy Number Non-Visit Code Contract Version Identifier Hierarchical Child Code Note Reference Code 25312 Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules

Nutrient Administration Method Code Patient Facility State Code Purchased Service Provider Middle Name Nutrient Administration Technique Code Patient Facility Zip Code Purchased Service Provider Name Additional Onset Date Patient First Address Line Text Ordering Provider City Name Patient First Name Purchased Service Provider Second Address Ordering Provider Contact Name Patient Gender Code Line Ordering Provider First Address Line Patient Height Purchased Service Provider Secondary Ordering Provider First Name Patient Last Name Identifier Ordering Provider Identifier Patient Marital Status Code Purchased Service Provider State Code Ordering Provider Last Name Patient Middle Name Purchased Service Provider ZIP Code Ordering Provider Middle Name Patient Name Suffix Quantity Qualifier Ordering Provider Name Additional Text Patient Primary Identifier Record Format Code Ordering Provider Name Suffix Patient Second Address Line Reference Identification Qualifier Ordering Provider Second Address Line Patient Secondary Identifier Referral Number Ordering Provider Secondary Identifier Patient Signature Source Code Referring Provider City Name Ordering Provider State Code Patient State Code Referring Provider Contact Name Ordering Provider ZIP Code Patient ZIP Code Referring Provider First Address Line Original Line Item Reference Number Pay-to Provider Additional Name Referring Provider First Name Originator Application Transaction Identifier Pay-to Provider City Name Referring Provider Identification Number Other Employer Additional Name Pay-to Provider Contact Name Referring Provider Last Name Other Employer City Name Pay-to Provider First Address Line Referring Provider Middle Name Other Employer First Address Line Pay-to Provider First Name Referring Provider Name Additional Text Other Employer First Name Pay-to Provider Identifier Referring Provider Name Suffix Other Employer Last or Organization Name Pay-to Provider Last or Organizational Name Referring Provider Second Address Line Other Employer Middle Name Pay-to Provider Middle Name Referring Provider Secondary Identifier Other Employer Second Address Line Pay-to Provider Name Suffix Referring Provider State Code Other Employer State Code Pay-to Provider Second Address Line Referring Provider ZIP Code Other Employer ZIP Code Pay-to Provider State Code Reimbursement Rate Other Insured Additional Identifier Pay-to Provider ZIP Code Reject Reason Code Other Insured Additional Name Payer Additional Identifier Related Hospitalization Admission Date Other Insured Birth Date Payer Additional Name Related Hospitalization Discharge Date Payer City Name Other Insured City Name Related Nursing Home Admission Date Payer First Address Line Other Insured First Address Line Related-Causes Code Payer Identifier Other Insured First Name Rendering Provider City Name Payer Name Other Insured Gender Code Rendering Provider Contact Name Payer Paid Amount Other Insured Identifier Rendering Provider First Address Line Payer Responsibility Sequence Number Code Other Insured Last Name Payer Second Address Line Rendering Provider First Name Other Insured Middle Name Payer State Code Rendering Provider Identifier Other Insured Name Suffix Payer ZIP Code Rendering Provider Last Name Other Insured Plan Name or Program Name Period Count Rendering Provider Middle Name Other Insured Second Address Line Place of Service Code Rendering Provider Name Additional Text Other Insured State Code Policy Compliance Code Rendering Provider Name Suffix Other Insured ZIP Code Postage Claimed Amount Rendering Provider Second Address Line Other Payer Additional Name Text Prescription Amino Acid Concentration Rendering Provider Secondary Identifier Other Payer City Name Percent Rendering Provider State Code Other Payer Covered Amount Prescription Date Rendering Provider ZIP Code Other Payer Discount Amount Prescription Dextrose Concentration Percent Rental Equipment Billing Frequency Code Other Payer Federal Mandate Amount Prescription Lipid Concentration Percent Rental Price Amount Other Payer First Address Line Prescription Lipid Milliliter Use Count Repriced Claim Reference Number Other Payer Interest Amount Prescription Number Repriced Line Item Reference Number Other Payer Last or Organization Name Prescription Period Count Repricing Organization Identifier Other Payer Patient Paid Amount Pricing Methodology Repricing Per Diem or Flat Rate Amount Other Payer Patient Responsibility Amount Prior Authorization Number Resource Utilization Group Number Other Payer Per Day Limit Amount Procedure Modifier Resubmission Number Other Payer Pre-Tax Claim Total Amount Product Name Retirement or Insurance Card Date Other Payer Primary Identifier Product/Service ID Qualifier Review By Code Indicator Other Payer Second Address Line Product/Service Procedure Code Sales Tax Amount Other Payer Secondary Identifier Prognosis Code Sample Selection Modules Other Payer State Code Property Casualty Claim Number Saving Amount Other Payer Tax Amount Provider or Supplier Signature Indicator School City Name Other Payer ZIP Code Provider Code School Contact Name Oxygen Saturation Quantity Provider Identifier School First Address Line Oxygen Saturation Test Date Provider Organization Code School Name Additional Text Paid Service Unit Count Provider Signature Date School Name Paramedic Contact Name Provider Specialty Certification Code School Primary Identifier Patient Account Number Provider Specialty Code School Second Address Line Patient Additional Name Purchase Price Amount School State Code Patient Age Purchase Service Charge Amount School ZIP Code Patient Amount Paid Purchase Service Provider Identifier Second Admission Date Patient Birth Date Purchase Service State Code Second Discharge Date Patient City Name Purchased Service Provider City Name Service Date Patient Death Date Purchased Service Provider Contact Name Service From Date Patient Facility Additional Name Text Purchased Service Provider First Address Service Line Paid Amount Patient Facility City Name Line Service Type Code Patient Facility First Address Line Purchased Service Provider First Name Service Unit Count Patient Facility Name Purchased Service Provider Last or Ship/Delivery or Calendar Pattern Code Patient Facility Second Address Line Organization Name Ship/Delivery Pattern Time Code Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules 25313

Shipped Date 1. Implementation Guide and Source Contract Version Identifier Similar Illness or Symptom Date The source of the implementation guide for Cost Report Day Count Special Program Indicator the institutional health care claim or Country Code Statement Covers Period End Date equivalent encounter is: Washington Covered Days or Visits Count Statement Covers Period Start Date Publishing Company, 806 W. Diamond Ave., Creation Date Student Status Code Suite 400, Gaithersburg, MD, 20878, Credit or Debit Card Authorization Number Submittal Date Telephone 301–590–9337, FAX: 301–869– Credit or Debit Card Holder First Name Submitted Charge Amount 9460. The web site address is http:// Credit or Debit Card Holder Last or Submitter or Receiver Address Line www.wpc-edi.com/hipaa/ Organizational Name Submitter or Receiver City Name Credit or Debit Card Holder Middle Name Submitter or Receiver Contact Name 2. Data Elements Credit or Debit Card Maximum Amount Submitter or Receiver First Name Activities Permitted Credit or Debit Card Number Submitter or Receiver Identifier Adjusted Repriced Claim Reference Number Currency Code Submitter or Receiver Last or Organization Adjustment Amount Date Time Period Format Qualifier Name Adjustment Quantity Date/Time Qualifier Submitter or Receiver Middle Name Adjustment Reason Code Diagnosis Date Submitter or Receiver State Code Admission Date and Hour Discharge Hour Submitter or Receiver ZIP Code Admission Source Code Discipline Type Code Submitter Additional Name Admission Type Code Document Control Identifier Subscriber or Dependent Death Date Allowed Amount Employer Identification Number Subscriber Additional Identifier Amount Qualifier Code Employment Status Code Subscriber Birth Date Approved Amount Entity Identifier Code Subscriber Contact Name Approved Diagnosis Related Group Code Entity Type Qualifier Subscriber First Name Approved HCPCS Code Estimated Amount Due Subscriber Gender Code Approved Revenue Code Estimated Claim Due Amount Subscriber Identifier Approved Service Unit Count Exception Code Subscriber Last Name Assigned Number Explanation of Benefits Indicator Subscriber Marital Status Code Attachment Control Number Facility Code Qualifier Subscriber Middle Name Attachment Description Text Facility Type Code Subscriber Name Suffix Attachment Report Type Code File Creation Time Subscriber Postal ZIP Code Attachment Transmission Code Frequency Number Subscriber Second Address Line Attending Physician First Name Functional Limitation Code Subscriber State Attending Physician Last Name Group or Policy Number Supervising Provider City Name Attending Physician Middle Name Hierarchical Child Code Supervising Provider Contact Name Attending Physician Primary Identifier Hierarchical ID Number Supervising Provider First Address Line Auto Accident State or Province Code Hierarchical Level Code Supervising Provider First Name Benefits Assignment Certification Indicator Hierarchical Parent ID Number Supervising Provider Identification Number Billing Note Text Hierarchical Structure Code Supervising Provider Last Name Billing Provider City Name Home Health Certification Period Supervising Provider Middle Name Billing Provider Contact Name HCPCS Modifier Code Supervising Provider Name Additional Text Billing Provider First Address Line HCPCS/CPT–4 Code Supervising Provider Name Suffix Billing Provider Identifier Identification Code Qualifier Supervising Provider Second Address Line Billing Provider Last or Organizational Name Implant Date Supervising Provider Secondary Identifier Supervising Provider State Code Billing Provider Postal Zone or ZIP Code Implant Status Code Supervising Provider ZIP Code Billing Provider Second Address Line Implant Type Code Supporting Document Question Identifier Billing Provider State or Province Code Individual Relationship Code Supporting Document Response Code Certification Condition Indicator Industry Code Surgical Procedure Code Certification Type Code Information Release Code Terms Discount Percentage Claim Adjustment Group Code Insurance Type Code Test Performed Date Claim Days Count Insured Employer First Address Line Test Results Claim Disproportionate Share Amount Insured Employer First Name Time Period Qualifier Claim DRG Amount Insured Employer Identifier Total Claim Charge Amount Claim DRG Outlier Amount Insured Group Name Total Purchased Service Amount Claim Encounter Identifier Insured Group Number Total Visits Rendered Count Claim ESRD Payment Amount Investigational Device Exemption Identifier Transaction Segment Count Claim Filing Indicator Code Last Admission Date Transaction Set Control Number Claim Frequency Code Last Visit Date Transaction Set Identifier Code Claim HCPCS payable amount Leads Left In Patient Indicator Transaction Set Purpose Code Claim Indirect Teaching Amount Legal Representative City Name Treatment or Therapy Date Claim MSP Pass-through amount Legal Representative Contact Name Treatment Length Claim Note Text Legal Representative First Address Line Unit or Basis for Measurement Code Claim Original Reference Number Legal Representative First Name Value Added Network Trace Number Claim Payment Remark Code Legal Representative Last or Organization Version Identification Code Claim PPS capital amount Name Version Identifier Claim PPS capital outlier amount Legal Representative Middle Name Weekly Prescription Lipid Use Count Claim Total Denied Charge Amount Legal Representative Second Address Line Work Return Date Code Associated Amount Legal Representative State Code X-Ray Availability Indicator Code Code Associated Date Legal Representative ZIP Code Code Associated Quantity Lifetime Psychiatric Days Count C. Institutional Claim or Equivalent Code Category Lifetime Reserve Days Count Encounter Code List Qualifier Code Line Charge Amount The transaction selected for the Contact Function Code Line Item Denied Charge or Non-Covered institutional health care claim or equivalent Contract Amount Charge Amount encounter information is ASC X12N 837— Contract Code Manufacturer Identifier Health Care Claim: Institutional Contract Percentage Medicare Coverage Indicator (004010X096). Contract Type Code Medicare Paid at 100% Amount 25314 Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules

Medicare Paid at 80% Amount Patient Secondary Identifier Terms Discount Percentage Mental Status Code Patient State Code Time Period Qualifier Model Number Patient Status Code Total Claim Charge Amount Non-Covered Charge Amount Patient ZIP Code Total Medicare Paid Amount Non-Insured Employer City Name Payer Additional Identifier Total Visits Projected This Certification Non-Insured Employer First Address Line Payer City Name Count Non-Insured Employer First Name Payer First Address Line Transaction Segment Count Non-Insured Employer Identifier Payer Identifier Transaction Set Control Number Non-Insured Employer Last or Organization Payer Name Transaction Set Identifier Code Name Payer Paid Amount Transaction Set Purpose Code Non-Insured Employer Middle Name Payer Responsibility Sequence Number Code Unit or Basis for Measurement Code Non-Insured Employer Second Address Line Payer Second Address Line Value Added Network Trace Number Non-Insured Employer State Code Payer State Code Version Identification Code Non-Insured Employer ZIP Code Payer ZIP Code Visits Prior to Recertification Date Count Note Reference Code Period Count Warranty Expiration Date 1861J1 Facility Old Capital Amount Physician Contact Date Indicator Operating Physician First Name Physician Order Date Operating Physician Last Name Policy Compliance Code D. Dental Claim or Equivalent Encounter Operating Physician Middle Name Pricing Methodology The transaction selected for the dental Operating Physician Primary Identifier Prior Authorization Number health care claim or equivalent encounter is: Ordering Provider Identifier Procedure Modifier ASC X12N 837—Health Care Claim: Dental Ordering Provider Last Name Product/Service ID Qualifier (004010X097). Originator Application Transaction Identifier Product/Service Procedure Code 1. Implementation Guide and Source Other Employer City Name Professional Component Amount The source of the implementation guide for Other Employer First Address Line Prognosis Code the dental health care claim or equivalent Other Employer First Name PPS-Capital DSH DRG Amount encounter is: Washington Publishing Other Employer Last or Organization Name PPS-Capital Exception Amount Company, 806 W. Diamond Ave., Suite 400, Other Employer Second Address Line PPS-Capital FSP DRG Amount Gaithersburg, MD, 20878, Telephone 301– Other Employer Secondary Identifier PPS-Capital HSP DRG Amount 590–9337, FAX: 301–869–9460. The web site Other Employer State Code PPS-Capital IME amount address is http://www.wpc-edi.com/hipaa/ Other Employer ZIP Code PPS-Operating Federal Specific DRG Amount Other Insured Additional Identifier PPS-Operating Hospital Specific DRG 2. Data Elements Other Insured Birth Date Amount Accident Date Other Insured City Name Quantity Qualifier Adjudication or Payment Date Other Insured First Address Line Reference Identification Qualifier Adjustment Amount Other Insured First Name Reimbursement Rate Adjustment Quantity Other Insured Gender Code Reject Reason Code Adjustment Reason Code Other Insured Identifier Related-Causes Code Admission Date or Start of Care Date Other Insured Last Name Repriced Claim Reference Number Amount Qualifier Code Other Insured Middle Name Repricing Organization Identifier Anesthesia Unit Count Other Insured Plan Name or Program Name Repricing Per Diem or Flat Rate Amount Appliance Placement Date Other Insured Second Address Line Returned to Manufacturer Indicator Assigned Number Other Insured State Code Saving Amount Assistant Surgeon City Name Other Insured ZIP Code School City Name Assistant Surgeon First Address Line Other Payer City Name School First Address Line Assistant Surgeon First Name Other Payer First Address Line School Name Assistant Surgeon Last Name Other Payer Last or Organization Name School Primary Identifier Assistant Surgeon Middle Name Other Payer Patient Paid Amount School Second Address Line Assistant Surgeon Primary Identification Other Payer Primary Identifier School State Code Number Other Payer Second Address Line School ZIP Code Assistant Surgeon Second Address Line Other Payer Secondary Identifier Serial Number Assistant Surgeon State Code Other Payer State Code Service Date Assistant Surgeon Suffix Name Other Payer ZIP Code Service From Date Assistant Surgeon ZIP Code Other Physician First Name Service Line Paid Amount Attachment Control Number Other Physician Identifier Service Line Rate Attachment Report Type Code Other Physician Last Name Service Line Revenue Code Attachment Transmission Code Other Physician Middle Name Service Unit Count Auto Accident State or Province Code Paid From Part A Medicare Trust Fund Statement From or To Date Benefits Assignment Certification Indicator Amount Submission or Resubmission Number Billing Provider City Name Paid From Part B Medicare Trust Fund Submitted Charge Amount Billing Provider Credit Card Identifier Amount Submitter or Receiver Contact Name Billing Provider First Address Line Patient Account Number Submitter or Receiver Identifier Billing Provider First Name Patient Amount Paid Submitter or Receiver Last or Organization Billing Provider Identifier Patient Birth Date Name Billing Provider Last or Organizational Name Patient City Name Subscriber Additional Identifier Billing Provider Middle Name Patient Discharge Facility Type Code Subscriber Birth Date Billing Provider Name Suffix Patient First Address Line Subscriber First Address Line Billing Provider Postal Zone or ZIP Code Patient First Name Subscriber First Name Billing Provider Second Address Line Patient Gender Code Subscriber Gender Code Billing Provider State or Province Code Patient Last Name Subscriber Last Name Claim Adjustment Group Code Patient Liability Amount Subscriber Marital Status Code Claim Encounter Identifier Patient Marital Status Code Subscriber Middle Name Claim Filing Indicator Code Patient Middle Name Subscriber Second Address Line Claim Patient Name Suffix Subscriber State Submission Reason Code Patient Primary Identifier Surgery Date Clinical Laboratory Improvement Patient Second Address Line Surgical Procedure Code Amendment Number Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules 25315

Code List Qualifier Code Other Insured Gender Code Rendering Provider City Name Contact Function Code Other Insured Identifier Rendering Provider First Address Line Coordination of Benefits Code Other Insured Last Name Rendering Provider First Name Country Code Other Insured Middle Name Rendering Provider Identifier Creation Date Other Insured Name Suffix Rendering Provider Last Name Credit or Debit Card Authorization Number Other Insured Second Address Line Rendering Provider Middle Name Credit or Debit Card Holder First Name Other Insured State Code Rendering Provider Name Suffix Credit or Debit Card Holder Last or Other Insured ZIP Code Rendering Provider Second Address Line Organizational Name Other Payer Covered Amount Rendering Provider State Code Credit or Debit Card Holder Middle Name Other Payer Discount Amount Rendering Provider ZIP Code Credit or Debit Card Holder Name Suffix Other Payer Last or Organization Name Replacement Date Credit or Debit Card Maximum Amount Other Payer Patient Paid Amount Retirement or Insurance Card Date Credit or Debit Card Number Other Payer Patient Responsibility Amount School City Name Credit/Debit Flag Code Other Payer Primary Identifier School First Address Line Currency Code Patient Account Number School Name Date Time Period Format Qualifier Patient Amount Paid School Primary Identifier Date/Time Qualifier Patient Birth Date School Second Address Line Destination Payer Code Patient City Name School State Code Diagnosis Code Patient First Address Line School ZIP Code Diagnosis Date Patient First Name Service Date Diagnosis Type Code Patient Gender Code Service Line Paid Amount Discharge Date/End Of Care Date Patient Last Name Student Status Code Entity Identifier Code Patient Marital Status Code Submitter or Receiver Address Line Entity Type Qualifier Patient Middle Name Submitter or Receiver City Name Facility Code Qualifier Patient Name Suffix Submitter or Receiver Contact Name Facility Type Code Patient Primary Identifier Submitter or Receiver First Name File Creation Time Patient Second Address Line Submitter or Receiver Identifier Group or Policy Number Patient Signature Source Code Submitter or Receiver Last or Organization Hierarchical Child Code Patient State Code Name Hierarchical ID Number Patient ZIP Code Submitter or Receiver Middle Name Hierarchical Level Code Pay-to-Provider City Name Submitter or Receiver State Code Hierarchical Parent ID Number Pay-to-Provider First Address Line Submitter or Receiver ZIP Code Hierarchical Structure Code Pay-to-Provider First Name Subscriber Birth Date Identification Code Qualifier Pay-to-Provider Identifier Subscriber First Address Line Individual Relationship Code Pay-to-Provider Last or Organizational Name Subscriber First Name Information Release Code Pay-to-Provider Middle Name Subscriber Gender Code Information Release Date Pay-to-Provider Name Suffix Subscriber Identifier Initial Placement Date Pay-to-Provider Second Address Line Subscriber Last Name Insured Employer First Address Line Pay-to-Provider State Code Subscriber Marital Status Code Insured Employer First Name Pay-to-Provider ZIP Code Subscriber Middle Name Insured Employer Identifier Payer Additional Identifier Subscriber Name Suffix Insured Employer Middle Name Payer City Name Subscriber Postal ZIP Code Insured Employer Name Suffix Payer First Address Line Subscriber Second Address Line Insured Group Name Payer Identifier Subscriber State Insured Group Number Payer Name Title XIX Identification Number Laboratory or Facility City Name Payer Paid Amount Tooth Code Laboratory or Facility First Address Line Payer Responsibility Sequence Number Code Tooth Number Laboratory or Facility Name Payer Second Address Line Tooth Status Code Laboratory or Facility Postal ZIP or Zonal Payer State Code Tooth Surface Code Payer ZIP Code Total Claim Charge Amount Laboratory or Facility Primary Identifier Periodontal Charting Measurement Transaction Segment Count Laboratory or Facility Second Address Line Policy Name Transaction Set Control Number Laboratory or Facility State or Province Code Predetermination of Benefits Identifier Transaction Set Identifier Code Legal Representative or Responsible Party Predetermination of Benefits Indicator Transaction Set Purpose Code Identifier Prior Authorization Number Unit or Basis for Measurement Code Legal Representative City Name Prior Placement Date Legal Representative First Address Line Procedure Count Addendum 2—Health Care Payment and Legal Representative First Name Procedure Modifier Remittance Advice Legal Representative Last or Organization Product/Service ID Qualifier The transaction selected for the health care Name Product/Service Procedure Code payment and remittance advice is ASC X12N Legal Representative Middle Name Prothesis, Crown or Inlay Code 835—Health Care Claim Payment/Advice Legal Representative Second Address Line Provider or Supplier Signature Indicator (004010X091). Legal Representative State Code Provider Signature Date Legal Representative Suffix Name Quantity Qualifier A. Implementation Guide and Source Legal Representative ZIP Code Reference Identification Qualifier The source of the implementation guide for Line Charge Amount Referring Provider City Name the ASC X12N 835—Health Care Claim Medicare Assignment Code Referring Provider First Address Line Payment/Advice (004010X091) is: Oral Cavity Designation Code Referring Provider First Name Washington Publishing Company, 806 W. Originator Application Transaction Identifier Referring Provider Identification Number Diamond Ave., Suite 400, Gaithersburg, MD, Orthodontic Treatment Months Count Referring Provider Last Name 20878, Telephone 301–590–9337, FAX: 301– Orthodontic Treatment Months Remaining Referring Provider Middle Name 869–9460. The website address is http:// Count Referring Provider Name Suffix www.wpc-edi.com/hipaa/ Other Insured Birth Date Referring Provider Second Address Line Other Insured City Name Referring Provider State Code B. Data Elements Other Insured First Address Line Referring Provider ZIP Code Account Number Qualifier Other Insured First Name Related-Causes Code Additional Payee Identifier 25316 Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules

Adjustment Amount Patient Middle Name Total Covered Day Count Adjustment Quantity Patient Name Prefix Total Day Outlier Amount Adjustment Reason Code Patient Name Suffix Total Deductible Amount Amount Paid to Patient Patient Status Code Total Denied Charge Amount Amount Qualifier Code Payee City Name Total Discharge Count Assigned Number Payee First Line Address Total Disp. Share Amount Average DRG length of stay Payee Identification Code Total DRG Amount Average DRG weight Payee Name Total Federal-Specific Amount Century Payee Postal Zip Code Total Gramm-Rudman Reduction Amount Check or EFT Trace Number Payee Second Line Address Total Hospital-Specific Amount Check/EFT Issue Date Payee State Code Total HCPCS Payable Amount Claim Adjustment Group Code Payer City Name Total HCPCS Reported Charge Amount Claim Contact Communications Number Payer Claim Control Number Total Indirect Medical Education Amount Claim Contact Name Payer Contact Communication Number Total Interest Amount Claim Date Payer Contact Name Total MSP Pass-Through Amount Claim Disproportionate Share Amount Payer First Address Line Total MSP Patient Liability Met Amount Claim ESRD Payment Amount Payer Identifier Total MSP Payer Amount Claim Filing Indicator Code Payer Name Total Non-Covered Charge Amount Claim Frequency Code Payer Process Date Total Non-Lab Charge Amount Claim HCPCS payable amount Payer Second Address Line Total Noncovered Charge Amount Claim Indirect Teaching Amount Payer State Code Total Noncovered Day Count Claim MSP Pass-through amount Payer ZIP Code Total Outlier Day Count Claim Payment Remark Code Payment Format Code Total Patient Reimbursement Amount Claim PPS capital amount Payment Method Code Total Professional Component Amount Claim PPS capital outlier amount Procedure Modifier Total Provider Payment Amount Claim Status Code Product/Service ID Qualifier Total PIP Adjustment Amount Claim Supplemental Information Amount Product/Service Procedure Code Text Total PIP Claim Count Claim Supplemental Information Quantity Product/Service Procedure Code Total PPS Capital FSP DRG Amount Code List Qualifier Code Production Date Total PPS Capital HSP DRG Amount Communication Number Extension Professional Component Amount Total PPS DSH DRG Amount Communication Number Qualifier Provider Adjustment Amount Contact Function Code Provider Adjustment Identifier Trace Type Code Corrected Insured Identification Indicator Provider First Name Transaction Handling Code Corrected Patient or Insured First Name Provider Identifier Transaction Segment Count Corrected Patient or Insured Last Name Provider Last or Organization Name Transaction Set Control Number Corrected Patient or Insured Middle Name Provider Middle Name Transaction Set Identifier Code Corrected Patient or Insured Name Prefix Provider Name Prefix Units of Service Paid Count Corrected Patient or Insured Name Suffix Provider Name Suffix Version Identifier Corrected Priority Payer Identification PPS-Capital DSH DRG Amount Addendum 3—Coordination of Benefits Number PPS-Capital Exception Amount Corrected Priority Payer Name PPS-Capital FSP DRG Amount A. Professional Claim Coordination of Cost Report Day Count PPS-Capital HSP DRG Amount Benefits Covered Days or Visits Count PPS-Capital IME amount The transaction selected for the Credit/Debit Flag Code PPS-Operating Federal Specific DRG Amount professional claim coordination of benefits is Crossover Carrier Identifier PPS-Operating Hospital Specific DRG ASC X12N 837—Health Care Claim: Crossover Carrier Name Amount Professional (004010X098). Currency Code Quantity Qualifier 1. Implementation Guide and Source Date/Time Qualifier Receiver or Provider Account Number Depository Financial Institution (DFI) Receiver Identifier The source of the implementation guide for Identifier Receiver/Provider Bank ID Number the professional claim coordination of Depository Financial Institution (DFI) ID Reference Identification Qualifier benefits transaction set is: Washington Number Qualifier Reimbursement Rate Publishing Company, 806 W. Diamond Ave., Description Text Remark Code Suite 400, Gaithersburg, MD, 20878, Diagnosis Related Group (DRG) Weight Sender Account Number Telephone 301–590–9337, FAX: 301–869– Diagnosis Related Group (DRG) Sender DFI Identifier 9460. The web site address is http:// Discharge Fraction Service Date www.wpc-edi.com/hipaa/ Entity Identifier Code Service Supplemental Amount 2. Data Elements Entity Type Qualifier Service Supplemental Quantity Count Data elements are found in addendum 1, Exchange Rate Submitted Charge Amount B.2. Facility Type Code Submitted Line Charges Paid Fiscal Period Date Subscriber First Name B. Institutional Claim Coordination of Identification Code Qualifier Subscriber Identifier Benefits Lifetime Psychiatric Days Count Subscriber Last Name The transaction selected for the Line Item Provider Payment Amount Subscriber Middle Name institutional claim coordination of benefits is Location Identification Code Subscriber Name Prefix ASC X12N 837—Health Care Claim: Location Qualifier Subscriber Name Suffix Institutional (004010X096). National Uniform Billing Committee Revenue Total Actual Provider Payment Amount Code Total Blood Deductible 1. Implementation Guide and Source Old Capital Amount Total Capital Amount The source of the implementation guide for Original Service Unit Count Total Claim Charge Amount the institutional claim coordination of Originating Company Supplemental Code Total Claim Count benefits transaction set is: Washington Other Claim Related Identifier Total Coinsurance Amount Publishing Company, 806 W. Diamond Ave., Patient Control Number Total Contractual Adjustment Amount Suite 400, Gaithersburg, MD, 20878, Patient First Name Total Cost Outlier Amount Telephone 301–590–9337, FAX: 301–869– Patient Last Name Total Cost Report Day Count 9460. The web site address is http:// Patient Liability Amount Total Covered Charge Amount www.wpc-edi.com/hipaa/ Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules 25317

2. Data Elements Identification Code Qualifier 834—Benefit Enrollment and Maintenance Data elements are found in Addendum 1, Information Receiver Additional Address Transaction Set (004010X095). C.2. Information Receiver Address Information Receiver City A. Implementation Guide and Source C. Dental Claim Coordination of Benefits Information Receiver First Name The source of the implementation guide for The transaction selected for the dental Information Receiver Identification Number the benefit enrollment and maintenance claim coordination of benefits is ASC X12N Information Receiver Last or Organization transaction set is: Washington Publishing 837—Health Care Claim: Dental Name Company, 806 W. Diamond Ave., Suite 400, (004010X097). Information Receiver Middle Name Gaithersburg, MD, 20878, Telephone 301– Information Receiver Name Prefix 590–9337, FAX: 301–869–9460. The web site 1. Implementation Guide and Source Information Receiver Name Suffix address is http://www.wpc-edi.com/hipaa/ The source of implementation guide for the Information Receiver Specific Location dental claim coordination of benefits Information Receiver State B. Data Elements transaction set is: Washington Publishing Information Receiver ZIP Code Label—name of elements Company, 806 W. Diamond Ave., Suite 400, Line Charge Amount Account Address Information Gaithersburg, MD, 20878, Telephone 301– Line Item Control Number Account City Name 590–9337, FAX: 301–869–9460. The web site Line Item Service Date Account Communication Number address is http://www.wpc-edi.com/hipaa/ Location Qualifier Account Contact Inquiry Reference Number 2. Data Elements Original Service Unit Count Account Contact Name Originator Application Transaction Identifier Account Country Code See Addendum 1, D.2. Patient Control Number Account Effective Date D. Retail Drug Claim Coordination of Benefits Patient First Name Account Identification Code Patient Last Name Account Monetary Amount The transactions selected for retail drug Patient Middle Name coordination of benefits is NCPDP Account Number Qualifier Patient Name Prefix Telecommunications Standard Format Account Postal ZIP Code Patient Name Suffix version 3.2 and the equivalent NCPDP Batch Account State Code Payer City Name Standard Version 1.0. Action Code Payer Claim Control Number Additional Account Identifier 1. Implementation Guide and Source Payer First Address Line Additional Other Coverage Identifier The source of implementation guide for the Payer Identifier Adjustment Amount retail drug claim coordination of benefits Payer Name Adjustment Reason Code Characteristic transaction set is: National Council for Payer Second Address Line Adjustment Reason Code Prescription Drug Programs, 4201 North 24th Payer State Code Amount Qualifier Code Street, Suite 365, Phoenix, AZ, 85016, Payer ZIP Code Assigned Number Telephone 602–957–9105, FAX 602–955– Payment Method Code Benefit Account Number 0749. The web site address is http:// Procedure Modifier Benefit Status Code www.ncpdp.org Product/Service ID Qualifier Birth Sequence Number 2. Data Elements Provider First Name Card Count Provider Identifier Citizenship Status Code See Addendum 1, A.2. Provider Last or Organization Name Code List Qualifier Code Addendum 4—Health Claim Status Provider Middle Name Communication Number Qualifier Provider Name Prefix Communication Number The transaction selected for the health Provider Name Suffix Consolidated Omnibus Budget Reconciliation claim status is ASC X12N 276/277—Health Reference Identification Qualifier Act (COBRA) Qualifying Event Code Care Claim Status Request and Response Revenue Code Contact Function Code (004010X093). Service Identification Code Contact Inquiry Reference A. Implementation Guide and Source Service Line Date Coordination of Benefits Code The source of the implementation guide for Service Unit Count Coordination of Benefits Date the health claim status transaction set is: Status Information Effective Date Country Code Washington Publishing Company, 806 W. Subscriber Birth Date Coverage Level Code Diamond Ave., Suite 400, Gaithersburg, MD, Subscriber City Creation Date 20878, Telephone 301–590–9337, FAX: 301– Subscriber First Address Line Credit/Debit Flag Code 869–9460. The website address is http:// Subscriber First Name Current Health Condition Code www.wpc-edi.com/hipaa/ Subscriber Gender Code Date Time Period Format Qualifier Subscriber Identifier Date/Time Qualifier B. Data Elements Subscriber Last Name Dependent Employer Identification Code Adjudication or Payment Date Subscriber Middle Name Dependent Employer Name Amount Qualifier Code Subscriber Name Prefix Dependent Employment Date Bill Type Identifier Subscriber Name Suffix Dependent School Date Check or EFT Trace Number Subscriber Postal ZIP Code Dependent School Identification Code Check/EFT Issue Date Subscriber Second Address Line Dependent School Name Claim Payment Amount Subscriber State Description Text Claim Service Period Total Claim Charge Amount Diagnosis Code Creation Date Trace Type Code Disability Eligibility Date Date Time Period Format Qualifier Transaction Segment Count Disability Maximum Entitlement Amount Date/Time Qualifier Transaction Set Control Number Disability Type Code Entity Identifier Code Transaction Set Identifier Code Employment Status Code Entity Type Qualifier Transaction Set Purpose Code Enrollment Control Total Extra Narrative Data Transaction Type Code Entity Identifier Code Health Care Claim Status Category Code [Direct Comments to Judy Ball, Enrollment Entity Relationship Code Health Care Claim Status Code and Eligibility IT] Entity Type Qualifier Hierarchical Child Code File Creation Time Hierarchical ID Number Addendum 5—Benefit Enrollment and First Diagnosed Date Hierarchical Level Code Maintenance Frequency Code Hierarchical Parent ID Number The transaction selected for benefit Gender Code Hierarchical Structure Code enrollment and maintenance is ASC X12N Group or Policy Number 25318 Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules

Health Coverage Eligibility Date Subscriber First Name Dependent Benefit Date Health-Related Code Subscriber Height Dependent Birth Date Identification Card Type Code Subscriber Identifier Dependent City Name Identification Code Qualifier Subscriber Last Name Dependent Communications Number Individual Relationship Code Subscriber Middle Name Dependent Contact Name Industry Code Subscriber Name Prefix Dependent First Line Address Insurance Eligibility Date Subscriber Name Suffix Dependent First Name Insurance Group Number Subscriber Postal ZIP Code Dependent Gender Code Insurance Line Code Subscriber Previous Weight Dependent Identification Code Insurer Contact Inquiry Reference Subscriber Second Address Line Dependent Last Name Insurer Contact Name Subscriber State Dependent Middle Name Insurer Contact Number Time Zone Code Dependent Name Suffix Insurer Entity Relationship Code Transaction Segment Count Dependent Postal Zip Code Insurer Identification Code Transaction Set Control Number Dependent Second Line Address Insurer Name Transaction Set Identifier Code Dependent State Code Issuing State Transaction Set Purpose Code Dependent Trace Number Last Visit Reason Text TPA or Broker Account Address Description Text Late Reason Code TPA or Broker Account Amount Eligibility or Benefit Amount Location Qualifier TPA or Broker Account City Name Eligibility or Benefit Information Maintenance Reason Code TPA or Broker Account Contact Eligibility or Benefit Percent Maintenance Type Code Communication Number Entity Identifier Code Marital Status Code TPA or Broker Account Contact Inquiry Entity Type Qualifier Master Policy Number Reference File Creation Time Medicare Plan Code TPA or Broker Account Contact Name Follow-up Action Code Member Additional Address TPA or Broker Account Number Free-Form Message Text Member City Name TPA or Broker Account Postal Code Handicap Indicator Code Member Contact Name TPA or Broker Account State or Province Hierarchical Child Code Member Postal Code Code Hierarchical ID Number Member State or Province Code TPA or Broker Additional Account Reference Hierarchical Level Code Monetary Amount Identification Number Hierarchical Parent ID Number Occupation Code TPA or Broker Additional Name Hierarchical Structure Code Other Insurance Company Identification TPA or Broker Communication Number Identification Code Qualifier Code TPA or Broker Contact Inquiry Reference Individual Relationship Code Other Insurance Company Name Number Information Receiver Additional Address Payer Responsibility Sequence Number Code TPA or Broker Country Code Information Receiver Additional Identifier Plan Coverage Description Text TPA or Broker Identification Code Information Receiver Address Policy Name TPA or Broker Name Information Receiver City Pre-disability Work Days Count TPA or Broker State Code Information Receiver Contact Name Premium Contribution Amount Underwriting Decision Code Information Receiver First Name Previous Transaction Identifier Version Identification Code Information Receiver Identification Number Primary Insured Collateral Dependent Count Weight Change Text Information Receiver Last or Organization Primary Insured Sponsored Dependent Count Work Intensity Code Name Product Option Code Yes/No Condition or Response Code Information Receiver Middle Name Product/Service ID Qualifier Addendum 6—Eligibility for a Health Plan Information Receiver Name Suffix Provider Code Information Receiver State The transaction selected for the eligibility Provider Communications Number Information Receiver Trace Number for a health plan is ASC X12N 270/271— Provider Contact Inquiry Reference Information Receiver ZIP Code Health Care Eligibility Inquiry and Response Provider Contact Name Information Source Contact Name (004010X092). Provider Eligibility Date Information Source Process Date Provider First Name A. Implementation Guide and Source Insurance Eligibility Date Provider Identifier The source of the implementation guide for Insurance Type Code Provider Last or Organization Name eligibility for a health plan transaction set is: Insured Indicator Provider Middle Name Washington Publishing Company, 806 W. Location Identification Code Provider Name Prefix Diamond Ave., Suite 400, Gaithersburg, MD, Location Qualifier Provider Name Suffix 20878, Telephone 301-590–9337, FAX: 301– Loop Identifier Code Quantity Count 869–9460. The website address is http:// Maintenance Reason Code Quantity Qualifier www.wpc-edi.com/hipaa/ Maintenance Type Code Race or Ethnicity Code Network Services Code Reference Identification Qualifier B. Data Elements Originating Company Identifier Sponsor Additional Name Labels Originating Company Secondary Identifier Sponsor City Name Agency Qualifier Code Period Count Sponsor Contact Name Amount Qualifier Code Plan Coverage Description Text Sponsor Country Code Authorization Indicator Code Plan Sponsor Name Sponsor Identifier Benefit Coverage Level Code Printer Carriage Control Code Sponsor Name Benefit Used or Available Amount Prior Authorization Number Sponsor State Code Birth Sequence Number Prior Authorization Text Sponsor Street Address Communication Number Qualifier Procedure Coding Method Sponsor Zip Code Communication Number Procedure Modifier Student Status Code Contact Function Code Product/Service ID Qualifier Subscriber or Dependent Death Date Country Code Provider Address 1 Subscriber Additional Identifier Coverage Level Code Provider Address 2 Subscriber Birth Date Creation Date Provider City Subscriber City Date Time Period Format Qualifier Provider Code Subscriber County Code Date/Time Qualifier Provider Contact Name Subscriber Current Weight Dependent Additional Identification Text Provider Contact Number Subscriber First Address Line Dependent Additional Identifier Provider First Name Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules 25319

Provider Identifier Company, 806 W. Diamond Ave., Suite 400, Transaction Set Control Number Provider Last or Organization Name Gaithersburg, MD, 20878, Telephone 301– Transaction Set Identifier Code Provider Middle Name 590–9337, FAX: 301–869–9460. The website Unit or Basis for Measurement Code Provider Name Suffix address is http://www.wpc-edi.com/hipaa/ Addendum 8—Referral Certification and Provider Specialty Certification Code B. Data Elements Authority Provider Specialty Code Provider State Account Number Qualifier The transaction selected for the referral Provider Zip Adjustment Reason Code certification and authority is ASC X12N Quantity Qualifier Assigned Number 278—Health Care Services Review Receiver Additional Identifier Description Billed Premium Amount Information (004010X094). Contact Function Code Text A. Implementation Guide and Source Receiver Additional Identifier Contract or Invoice or Account Number Receiver Provider Additional Identifier Type Country Code The source of the implementation guide for Code Coverage Period Date the referral certification and authority is: Receiver Provider Additional Identifier Credit/Debit Flag Code Washington Publishing Company, 806 W. Diamond Ave., Suite 400, Gaithersburg, MD, Receiver Trace Number Currency Code 20878, Telephone 301–590–9337, FAX: 301– Reference Identification Qualifier Date Time Period Format Qualifier 869–9460. The website address is http:// Reject Reason Code Date/Time Qualifier www.wpc-edi.com/hipaa/ Relationship To Insured Code Depository Financial Institution (DFI) Sample Selection Modulus Identifier B. Data Elements Service Type Code Depository Financial Institution (DFI) ID Number Qualifier Action Code Service Unit Count Admission Source Code Ship/Delivery or Calendar Pattern Code Employee Identification Number Entity Identifier Code Admission Type Code Ship/Delivery Pattern Time Code Agency Qualifier Code Source Additional Reference Identifier Exchange Rate Funds Issued Date Ambulance Transport Code Source City Name Ambulance Transport Reason Code Head Count Source Organization Name Ambulance Trip Destination Address Identification Code Qualifier Source Postal Zip Code Ambulance Trip Origin Address Individual Identifier Source Primary Identification Number Arterial Blood Gas Quantity Information Only Indicator Code Source State Code Certification Condition Indicator Information Receiver City Source Street Address Certification Expiration Date Information Receiver Last or Organization Spend Down Amount Certification Number Name Student Status Code Certification Type Code Information Receiver State Subscriber Additional Identifier Chiropractic Series Treatment Number Information Receiver ZIP Code Subscriber Additional Information Text Citizenship Status Code Subscriber Benefit Date Insurance Policy or Plan Identifier Code Category Subscriber Birth Date Line Item Control Number Code List Qualifier Code Subscriber Card Issue Date Organization Premium Identification Code Communication Number Qualifier Subscriber City Originating Company Identifier Complication Indicator Subscriber Contact Name Originating Company Supplemental Code Condition Codes Subscriber Contact Phone Number Payer Additional Name Contact Function Code Subscriber First Address Line Payer City Name Country Code Subscriber First Name Payer Contact Name Creation Date Subscriber Gender Code Payer Identifier Current Health Condition Code Subscriber Identifier Payer Name Daily Oxygen Use Count Subscriber Last Name Payer Process Date Date Time Period Format Qualifier Subscriber Middle Name Payer Second Address Line Date/Time Qualifier Subscriber Name Suffix Payer State Code Delay Reason Code Subscriber Postal ZIP Code Payer ZIP Code Dependent Additional Identification Text Subscriber Second Address Line Payment Action Code Dependent Additional Identifier Subscriber State Payment Format Code Dependent Birth Date Time Period Qualifier Payment Method Code Dependent Citizenship Country Code Trace Assigning Entity Additional Number Payroll Processor Additional Name Dependent First Name Trace Assigning Entity Number Payroll Processor City Name Dependent Gender Code Trace Number Payroll Processor Contact Name Dependent Identification Code Trace Type Code Payroll Processor First Address Line Dependent Last Name Transaction Segment Count Payroll Processor Identifier Dependent Marital Status Code Transaction Set Control Number Payroll Processor Name Dependent Middle Name Transaction Set Identifier Code Payroll Processor Second Address Line Dependent Name Prefix Transaction Set Purpose Code Payroll Processor State Code Dependent Name Suffix Transaction Type Code Payroll Processor ZIP Code Dependent Trace Number Unit or Basis for Measurement Code Policy Level Individual Name Diagnosis Code Valid Request Indicator Code Premium Delivery Date Diagnosis Date Value Added Network Trace Number Premium Payment Amount Diagnosis Type Code Premium Receiver First Address Line Entity Identifier Code Addendum 7—Health Plan Premium Premium Receiver Reference Identifier Entity Type Qualifier Payment Premium Receiver Second Address Line Equipment Reason Description The transaction selected for the health plan Receiver Account Number Facility Code Qualifier premium payment is ASC X12N 820— Receiver Additional Name Facility Type Code Payment Order/Remittance Advice Receiver Identifier File Creation Time Transaction Set (004010X061). Reference Identification Qualifier Follow-up Action Code Sender Account Number Free-Form Message Text A. Implementation Guide and Source Trace Number Full Destination Address The source of the implementation guide for Trace Type Code Full Origin Address the health plan premium payment Transaction Handling Code Hierarchical Child Code transaction set is: Washington Publishing Transaction Segment Count Hierarchical ID Number 25320 Federal Register / Vol. 63, No. 88 / Thursday, May 7, 1998 / Proposed Rules

Hierarchical Level Code Service Provider Contact Communication Valid Request Indicator Code Hierarchical Parent ID Number Number Version/Release/Industry Identifier Hierarchical Structure Code Service Provider Country Code X-Ray Availability Indicator Code 1861J1 Home Health Certification Period Service Provider First Address Line Facility Indicator Identification Code Qualifier Service Provider First Name [FR Doc. 98–11691 Filed 5–1–98; 9:04 am] Information Release Code Service Provider Identifier Insured Indicator Service Provider Last or Organization Name BILLING CODE 4120±01±P Last Admission Date Service Provider Middle Name Last Visit Date Service Provider Name Prefix Level of Service Code Service Provider Name Suffix DEPARTMENT OF HEALTH AND Medicare Coverage Indicator Service Provider Postal Code HUMAN SERVICES Monthly Treatment Count Service Provider Second Address Line Nature of Condition Code Service Provider State or Province Code Office of the Secretary Nursing Home Residential Status Code Service Provider Supplemental Identifier Originator Application Transaction Identifier Service Trace Number 45 CFR Part 142 Oxygen Delivery System Code Service Type Code Oxygen Equipment Type Code Service Unit Count [HCFA±0045-P] Oxygen Flow Rate Ship/Delivery or Calendar Pattern Code RIN 0938±AH99 Oxygen Saturation Quantity State Code Oxygen Test Condition Code Stretcher Purpose Description Text National Standard Health Care Oxygen Test Findings Code Subluxation Level Code Provider Identifier Oxygen Use Period Hour Count Subscriber Additional Identifier Patient Condition Description Text Subscriber Additional Information Text AGENCY: Health Care Financing Patient Discharge Facility Type Code Subscriber Birth Date Administration (HCFA), HHS. Patient Status Code Subscriber Citizenship Country Code ACTION: Proposed rule. Patient Weight Subscriber First Name Period Count Subscriber Gender Code SUMMARY: This rule proposes a standard Physician Contact Date Subscriber Identifier for a national health care provider Physician Order Date Subscriber Last Name identifier and requirements concerning Portable Oxygen System Flow Rate Subscriber Marital Status Code its use by health plans, health care Previous Certification Identifier Subscriber Middle Name Procedure Date Subscriber Name Prefix clearinghouses, and health care Procedure Monetary Amount Subscriber Name Suffix providers. The health plans, health care Procedure Quantity Subscriber Trace Number clearinghouses, and health care Product/Service ID Qualifier Surgery Date providers would use the identifier, Product/Service Procedure Code Text Surgical Procedure Code among other uses, in connection with Product/Service Procedure Code Time Period Qualifier certain electronic transactions. Prognosis Code Trace Type Code The use of this identifier would Proposed Admission Date Transaction Segment Count improve the Medicare and Medicaid Proposed Discharge Date Transaction Set Control Number programs, and other Federal health Proposed Surgery Date Transaction Set Identifier Code programs and private health programs, Provider Code Transaction Set Purpose Code Provider Contact Name Transaction Type Code and the effectiveness and efficiency of Provider Identifier Transport Distance the health care industry in general, by Provider Service State Code Treatment Count simplifying the administration of the Provider Specialty Certification Code Treatment Period Count system and enabling the efficient Provider Specialty Code Treatment Series Number electronic transmission of certain health Quantity Qualifier Unit or Basis for Measurement Code information. It would implement some Race or Ethnicity Code Utilization Management Organization (UMO) of the requirements of the Reference Identification Qualifier or Last Name Administrative Simplification subtitle Reject Reason Code Utilization Management Organization (UMO) of the Health Insurance Portability and Related-Causes Code First Address Line Accountability Act of 1996. Relationship To Insured Code Utilization Management Organization (UMO) Request Category Code First Name DATES: Comments will be considered if Requester Address First Address Line Utilization Management Organization (UMO) we receive them at the appropriate Requester Address Second Address Line Middle Name address, as provided below, no later Requester City Name Utilization Management Organization (UMO) than 5 p.m. on July 6, 1998. Requester Contact Communication Number Name Prefix ADDRESSES: Mail written comments (1 Requester Contact Name Utilization Management Organization (UMO) original and 3 copies) to the following Requester Country Code Name Suffix address: Health Care Financing Requester First Name Utilization Management Organization (UMO) Requester Identifier Second Address Line Administration, Department of Health Requester Last or Organization Name Utilization Managment Organization (UMO) and Human Services, Attention: HCFA– Requester Middle Name City Name 0045-P, P.O. Box 26585, Baltimore, MD Requester Name Prefix Utilization Managment Organization (UMO) 21207–0519. Requester Name Suffix Contact Communication Number If you prefer, you may deliver your Requester Postal Code Utilization Managment Organization (UMO) written comments (1 original and 3 Requester State or Province Code Contact Name copies) to one of the following Requester Supplemental Identifier Utilization Managment Organization (UMO) addresses: Respiratory Therapist Order Text Country Code Round Trip Purpose Description Text Utilization Managment Organization (UMO) Room 309–G, Hubert H. Humphrey Sample Selection Modulus Identifier Building, 200 Independence Avenue, Second Surgical Opinion Indicator Utilization Managment Organization (UMO) SW., Washington, DC 20201, or Service Authorization Date Postal Code Room C5–09–26, 7500 Security Service From Date Utilization Managment Organization (UMO) Boulevard, Baltimore, MD 21244– Service Provider City Name State or Province Code 1850.