42 U.S.C. § 1320d–1 — General requirements for adoption of standards

(a) Standards apply in whole or in part to: (1) health plans; (2) health-care clearinghouses; and (3) providers who electronically transmit health information for a section 1320d–2(a)(1) transaction. (b) Each standard must be consistent with reducing the administrative cost of providing and paying for care. (c)(1) Unless (2) applies, each standard must have been developed, adopted, or modified by a standard-setting organization. (2)(A) The Secretary may adopt a different standard if it would substantially reduce providers’ and plans’ administrative costs compared with alternatives and is adopted through title 5, chapter 5, subchapter III rulemaking. (B) If no standard-setting organization has developed, adopted, or modified a relevant standard, paragraph (1) does not apply and (f) applies. (3)(A) A standard may not be adopted unless the standard-setting organization consulted each organization in (B), or, for another standard, the Secretary consulted each of them before adoption while following (f). (B) Those organizations are the National Uniform Billing Committee, National Uniform Claim Committee, Workgroup for Electronic Data Interchange, and American Dental Association. (d) The Secretary must establish implementation specifications for every adopted standard. (e) Unless another law requires it, a standard may not require disclosure of trade secrets or confidential commercial information by someone subject to this part. (f) In following this part, the Secretary must rely on recommendations of the National Committee on Vital and Health Statistics and consult appropriate Federal and State agencies and private organizations. The Secretary must publish in the Federal Register every such recommendation about adopting a standard. (g) This section applies to a modification, including an addition, to a standard adopted under section 1320d–3(b) just as it applies to an initial standard under section 1320d–3(a). This section does not define “administrative costs,” “implementation specifications,” or “confidential commercial information.”