45 C.F.R. Subpart I—General Provisions for Transactions
Title 45 - Public Welfare
(a) Small health plans. All small health plans must comply with applicable requirements of subparts I through R of this part no later than October 16, 2003. (b) Covered entities that timely submitted a compliance plan. Any covered entity, other than a small health plan, that timely submitted a compliance plan with the Secretary under the provisions of section 2 of Pub. L. 107–105, 115 Stat. 1003 (ASCA) must comply with the applicable requirements of subparts I through R of this part no later than October 16, 2003. (c) Covered entities that did not timely submit a compliance plan. Any covered entity, other than a small health plan, that did not timely submit a compliance plan under the provisions of section 2 of Pub. L. 107-105, 115 Stat. 1003 (ASCA) must comply with the applicable requirements of subparts I through R of this part— (1) Beginning on October 16, 2002, and ending on October 15, 2003— (i) For the corresponding time period; or (ii) For the time period beginning on October 16, 2003. (2) Beginning on and after October 16, 2003, for the corresponding time period. [68 FR 8396, Feb. 20, 2003] (a) Designation of DSMOs. (1) The Secretary may designate as a DSMO an organization that agrees to conduct, to the satisfaction of the Secretary, the following functions: (i) Maintain standards adopted under this subchapter. (ii) Receive and process requests for adopting a new standard or modifying an adopted standard. (2) The Secretary designates a DSMO by notice in the (b) Maintenance of standards. Maintenance of a standard by the appropriate DSMO constitutes maintenance of the standard for purposes of this part, if done in accordance with the processes the Secretary may require. (c) Process for modification of existing standards and adoption of new standards. The Secretary considers a recommendation for a proposed modification to an existing standard, or a proposed new standard, only if the recommendation is developed through a process that provides for the following: (1) Open public access. (2) Coordination with other DSMOs. (3) An appeals process for each of the following, if dissatisfied with the decision on the request: (i) The requestor of the proposed modification. (ii) A DSMO that participated in the review and analysis of the request for the proposed modification, or the proposed new standard. (4) Expedited process to address content needs identified within the industry, if appropriate. (5) Submission of the recommendation to the National Committee on Vital and Health Statistics (NCVHS). A covered entity must not enter into a trading partner agreement that would do any of the following: (a) Change the definition, data condition, or use of a data element or segment in a standard. (b) Add any data elements or segments to the maximum defined data set. (c) Use any code or data elements that are either marked “not used” in the standard's implementation specification or are not in the standard's implementation specification(s). (d) Change the meaning or intent of the standard's implementation specification(s). A person or an organization may directly request copies of the implementation standards described in subparts I through R of this part from the publishers listed in this section. The Director of the Office of the Federal Register approves the implementation specifications described in this section for incorporation by reference in subparts I through R of this part in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The implementation specifications described in this paragraph are also available for inspection by the public at the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244 or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.php. Copy requests must be accompanied by the name of the standard, number, if applicable, and version number. Implementation specifications are available for the following transactions: (a) ASC X12N specifications. The implementation specifications for ASC X12N standards may be obtained from the Washington Publishing Company, PMB 161, 5284 Randolph Road, Rockville, MD, 20852–2116; Telephone (301) 949–9740; and FAX: (301) 949–9742. They are also available through the Washington Publishing Company on the Internet athttp://www.wpc-edi.com/. The transaction implementation specifications are as follows: (1) The ASC X12N 837—Health Care Claim: Dental, Version 4010, May 2000, Washington Publishing Company, 004010X097 and Addenda to Health Care Claim: Dental, Version 4010, October 2002, Washington Publishing Company, 004010X097A1, as referenced in §162.1102 and §162.1802. (2) The ASC X12N 837—Health Care Claim: Professional, Volumes 1 and 2, Version 4010, May 2000, Washington Publishing Company, 004010X098 and Addenda to Health Care Claim: Professional, Volumes 1 and 2, Version 4010, October 2002, Washington Publishing Company, 004010X098A1, as referenced in §162.1102 and §162.1802. (3) The ASC X12N 837—Health Care Claim: Institutional, Volumes 1 and 2, Version 4010, May 2000, Washington Publishing Company, 004010X096 and Addenda to Health Care Claim: Institutional, Volumes 1 and 2, Version 4010, October 2002, Washington Publishing Company, 004010X096A1 as referenced in §162.1102 and §162.1802. (4) The ASC X12N 835—Health Care Claim Payment/Advice, Version 4010, May 2000, Washington Publishing Company, 004010X091, and Addenda to Health Care Claim Payment/Advice, Version 4010, October 2002, Washington Publishing Company, 004010X091A1 as referenced in §162.1602. (5) ASC X12N 834—Benefit Enrollment and Maintenance, Version 4010, May 2000, Washington Publishing Company, 004010X095 and Addenda to Benefit Enrollment and Maintenance, Version 4010, October 2002, Washington Publishing Company, 004010X095A1, as referenced in §162.1502. (6) The ASC X12N 820—Payroll Deducted and Other Group Premium Payment for Insurance Products, Version 4010, May 2000, Washington Publishing Company, 004010X061, and Addenda to Payroll Deducted and Other Group Premium Payment for Insurance Products, Version 4010, October 2002, Washington Publishing Company, 004010X061A1, as referenced in §162.1702. (7) The ASC X12N 278—Health Care Services Review—Request for Review and Response, Version 4010, May 2000, Washington Publishing Company, 004010X094 and Addenda to Health Care Services Review—Request for Review and Response, Version 4010, October 2002, Washington Publishing Company, 004010X094A1, as referenced in §162.1302. (8) The ASC X12N–276/277 Health Care Claim Status Request and Response, Version 4010, May 2000, Washington Publishing Company, 004010X093 and Addenda to Health Care Claim Status Request and Response, Version 4010, October 2002, Washington Publishing Company, 004010X093A1, as referenced in §162.1402. (9) The ASC X12N 270/271—Health Care Eligibility Benefit Inquiry and Response, Version 4010, May 2000, Washington Publishing Company, 004010X092 and Addenda to Health Care Eligibility Benefit Inquiry and Response, Version 4010, October 2002, Washington Publishing Company, 004010X092A1, as referenced in §162.1202. (b) Retail pharmacy specifications. The implementation specifications for retail pharmacy standards may be obtained for a fee from the National Council for Prescription Drug Programs (NCPDP), 9240 E. Raintree Drive, Scottsdale, AZ 85260; Telephone (480) 477–1000; and FAX (480) 767–1042. They may also be obtained through the Internet at http://www.ncpdp.org. The transaction implementation specifications are as follows: (1) The Telecommunication Standard Implementation Guide Version 5, Release 1 (Version 5.1), September 1999, National Council for Prescription Drug Programs, as referenced in §162.1102, §162.1202, §162.1302, §162.1602, and §162.1802. (2) The Batch Standard Batch Implementation Guide, Version 1, Release 1 (Version 1.1), January 2000, supporting Telecommunication Standard Implementation Guide, Version 5, Release 1 (Version 5.1) for the NCPDP Data Record in the Detail Data Record, National Council for Prescription Drug Programs, as referenced in §162.1102, §162.1202, §162.1302, and §162.1802. (3) The National Council for Prescription Drug Programs (NCPDP) equivalent NCPDP Batch Standard Batch Implementation Guide, Version 1, Release 0, February 1, 1996, as referenced in §162.1102, §162.1202, §162.1602, and §162.1802. [68 FR 8396, Feb. 20, 2003, as amended at 69 FR 18803, Apr. 9, 2004] (a) General rule. Except as otherwise provided in this part, if a covered entity conducts with another covered entity (or within the same covered entity), using electronic media, a transaction for which the Secretary has adopted a standard under this part, the covered entity must conduct the transaction as a standard transaction. (b) Exception for direct data entry transactions. A health care provider electing to use direct data entry offered by a health plan to conduct a transaction for which a standard has been adopted under this part must use the applicable data content and data condition requirements of the standard when conducting the transaction. The health care provider is not required to use the format requirements of the standard. (c) Use of a business associate. A covered entity may use a business associate, including a health care clearinghouse, to conduct a transaction covered by this part. If a covered entity chooses to use a business associate to conduct all or part of a transaction on behalf of the covered entity, the covered entity must require the business associate to do the following: (1) Comply with all applicable requirements of this part. (2) Require any agent or subcontractor to comply with all applicable requirements of this part. (a) General rules. (1) If an entity requests a health plan to conduct a transaction as a standard transaction, the health plan must do so. (2) A health plan may not delay or reject a transaction, or attempt to adversely affect the other entity or the transaction, because the transaction is a standard transaction. (3) A health plan may not reject a standard transaction on the basis that it contains data elements not needed or used by the health plan (for example, coordination of benefits information). (4) A health plan may not offer an incentive for a health care provider to conduct a transaction covered by this part as a transaction described under the exception provided for in §162.923(b). (5) A health plan that operates as a health care clearinghouse, or requires an entity to use a health care clearinghouse to receive, process, or transmit a standard transaction may not charge fees or costs in excess of the fees or costs for normal telecommunications that the entity incurs when it directly transmits, or receives, a standard transaction to, or from, a health plan. (b) Coordination of benefits. If a health plan receives a standard transaction and coordinates benefits with another health plan (or another payer), it must store the coordination of benefits data it needs to forward the standard transaction to the other health plan (or other payer). (c) Code sets. A health plan must meet each of the following requirements: (1) Accept and promptly process any standard transaction that contains codes that are valid, as provided in subpart J of this part. (2) Keep code sets for the current billing period and appeals periods still open to processing under the terms of the health plan's coverage. When acting as a business associate for another covered entity, a health care clearinghouse may perform the following functions: (a) Receive a standard transaction on behalf of the covered entity and translate it into a nonstandard transaction (for example, nonstandard format and/or nonstandard data content) for transmission to the covered entity. (b) Receive a nonstandard transaction (for example, nonstandard format and/or nonstandard data content) from the covered entity and translate it into a standard transaction for transmission on behalf of the covered entity. (a) Requests for an exception. An organization may request an exception from the use of a standard from the Secretary to test a proposed modification to that standard. For each proposed modification, the organization must meet the following requirements: (1) Comparison to a current standard. Provide a detailed explanation, no more than 10 pages in length, of how the proposed modification would be a significant improvement to the current standard in terms of the following principles: (i) Improve the efficiency and effectiveness of the health care system by leading to cost reductions for, or improvements in benefits from, electronic health care transactions. (ii) Meet the needs of the health data standards user community, particularly health care providers, health plans, and health care clearinghouses. (iii) Be uniform and consistent with the other standards adopted under this part and, as appropriate, with other private and public sector health data standards. (iv) Have low additional development and implementation costs relative to the benefits of using the standard. (v) Be supported by an ANSI-accredited SSO or other private or public organization that would maintain the standard over time. (vi) Have timely development, testing, implementation, and updating procedures to achieve administrative simplification benefits faster. (vii) Be technologically independent of the computer platforms and transmission protocols used in electronic health transactions, unless they are explicitly part of the standard. (viii) Be precise, unambiguous, and as simple as possible. (ix) Result in minimum data collection and paperwork burdens on users. (x) Incorporate flexibility to adapt more easily to changes in the health care infrastructure (such as new services, organizations, and provider types) and information technology. (2) Specifications for the proposed modification. Provide specifications for the proposed modification, including any additional system requirements. (3) Testing of the proposed modification. Provide an explanation, no more than 5 pages in length, of how the organization intends to test the standard, including the number and types of health plans and health care providers expected to be involved in the test, geographical areas, and beginning and ending dates of the test. (4) Trading partner concurrences. Provide written concurrences from trading partners who would agree to participate in the test. (b) Basis for granting an exception. The Secretary may grant an initial exception, for a period not to exceed 3 years, based on, but not limited to, the following criteria: (1) An assessment of whether the proposed modification demonstrates a significant improvement to the current standard. (2) The extent and length of time of the exception. (3) Consultations with DSMOs. (c) Secretary's decision on exception. The Secretary makes a decision and notifies the organization requesting the exception whether the request is granted or denied. (1) Exception granted. If the Secretary grants an exception, the notification includes the following information: (i) The length of time for which the exception applies. (ii) The trading partners and geographical areas the Secretary approves for testing. (iii) Any other conditions for approving the exception. (2) Exception denied. If the Secretary does not grant an exception, the notification explains the reasons the Secretary considers the proposed modification would not be a significant improvement to the current standard and any other rationale for the denial. (d) Organization's report on test results. Within 90 days after the test is completed, an organization that receives an exception must submit a report on the results of the test, including a cost-benefit analysis, to a location specified by the Secretary by notice in the (e) Extension allowed. If the report submitted in accordance with paragraph (d) of this section recommends a modification to the standard, the Secretary, on request, may grant an extension to the period granted for the exception.
Title 45: Public Welfare
PART 162—ADMINISTRATIVE REQUIREMENTS
Subpart I—General Provisions for Transactions
§ 162.900 Compliance dates for transaction standards and code sets.
§ 162.910 Maintenance of standards and adoption of modifications and new standards.
§ 162.915 Trading partner agreements.
§ 162.920 Availability of implementation specifications.
§ 162.923 Requirements for covered entities.
§ 162.925 Additional requirements for health plans.
§ 162.930 Additional rules for health care clearinghouses.
§ 162.940 Exceptions from standards to permit testing of proposed modifications.
