Subpart I - General Provisions for Transactions
§162.900 - Compliance dates of the initial implementation of the code sets and transaction standards.
(a) Health care providers. A covered health care provider must comply with the applicable requirements of subparts I through N of this part no later than [OFR–insert 24 months after the effective date of the final rule in the Federal Register].
(b) Health plans. A health plan must comply with the applicable requirements of subparts I through R of this part no later than one of the following dates:
(1) Health plans other than small health plans-- [OFR–insert 24 months after the effective date of the final rule in the Federal Register].
(2) Small health plans-- [OFR–insert 36 months after the effective date of the final rule in the Federal Register].
(c) Health care clearinghouses. A health care clearinghouse must comply with the applicable requirements of subparts I through R of this part no later than [OFR–insert 24 months after the effective date of the final rule in the Federal Register].
(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 Federal Register.
(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) Access to implementation specifications. A person or organization may request copies (or access for inspection) of the implementation specifications for a standard described in subparts K through R of this part by identifying the standard by name, number, and version. The implementation specifications are available as follows:
(1) 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 at http://www.wpc-edi.com. The implementation specifications are as follows:
(iv) The ASC X12N 270/271- Health Care Eligibility Benefit Inquiry and Response, Version 4010, May 2000, Washington Publishing Company, 004010X092, as referenced in §162.1202.
(v) The ASC X12N 278 - Health Care Services Review - Request for Review and Response, Version 4010, May 2000, Washington Publishing Company, 004010X094, as referenced in §162.1302.
(vi) The ASC X12N 276/277 Health Care Claim Status Request and Response, Version 4010, May 2000, Washington Publishing Company, 004010X093, as referenced in §162.1402.
(vii) The ASC X12N 834 - Benefit Enrollment and Maintenance, Version 4010, May 2000, Washington Publishing Company, 004010X095, as referenced in §162.1502.
(viii) The ASC X12N 835 - Health Care Claim Payment/Advice, Version 4010, May 2000, Washington Publishing Company, 004010X091, as referenced in §162.1602.
(ix) The ASC X12N 820 - Payroll Deducted and Other Group Premium Payment for Insurance Products, Version 4010, May 2000, Washington Publishing Company, 004010X061, as referenced in §162.1702.
(2) Retail pharmacy specifications. The implementation specifications for all retail pharmacy standards may be obtained from the National Council for Prescription Drug Programs (NCPDP), 4201 North 24th Street, Suite 365, Phoenix, AZ, 85016; telephone 602-957-9105; and FAX 602-955-0749. It may also be obtained through the Internet at http://www.ncpdp.org. The implementation specifications are as follows:
(i) The Telecommunication Standard Implementation Guide, Version 5 Release 1, September 1999, National Council for Prescription Drug Programs, as referenced in §§162.1102, 162.1202, 162.1602, and 162.1802.
(ii) The Batch Standard Batch Implementation Guide, Version 1 Release 0, February 1, 1996, National Council for Prescription Drug Programs, as referenced in §§162.1102, 162.1202, 162.1602, and 162.1802.
(b) Incorporations by reference. The Director of the Office of the Federal Register approves the implementation specifications described in paragraph (a) of this section for incorporation by reference in subparts K through R of this part in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy of the implementation specifications may be inspected at the Office of the Federal Register, 800 North Capitol Street, NW, Suite 700, Washington, DC.
(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.
§162.930 Additional rules for health care clearinghouses.
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.
§162.940 Exceptions from standards to permit testing of proposed modifications.
(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 Federal Register.
(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.