42 U.S. Code § 1320d–1 - General requirements for adoption of standards
Any standard adopted under this part shall apply, in whole or in part, to the following persons:
(b) Reduction of costs
Any standard adopted under this part shall be consistent with the objective of reducing the administrative costs of providing and paying for health care.
(c) Role of standard setting organizations
(1) In general
Except as provided in paragraph (2), any standard adopted under this part shall be a standard that has been developed, adopted, or modified by a standard setting organization.
(2) Special rules
(A) Different standards
The Secretary may adopt a standard that is different from any standard developed, adopted, or modified by a standard setting organization, if—
(i) the different standard will substantially reduce administrative costs to health care providers and health plans compared to the alternatives; and
(B) No standard by standard setting organization
If no standard setting organization has developed, adopted, or modified any standard relating to a standard that the Secretary is authorized or required to adopt under this part—
(3) Consultation requirement
(A) In general
A standard may not be adopted under this part unless—
(i) in the case of a standard that has been developed, adopted, or modified by a standard setting organization, the organization consulted with each of the organizations described in subparagraph (B) in the course of such development, adoption, or modification; and
(d) Implementation specifications
The Secretary shall establish specifications for implementing each of the standards adopted under this part.
(e) Protection of trade secrets
Except as otherwise required by law, a standard adopted under this part shall not require disclosure of trade secrets or confidential commercial information by a person required to comply with this part.
(f) Assistance to Secretary
In complying with the requirements of this part, the Secretary shall rely on the recommendations of the National Committee on Vital and Health Statistics established under section 242k (k) of this title, and shall consult with appropriate Federal and State agencies and private organizations. The Secretary shall publish in the Federal Register any recommendation of the National Committee on Vital and Health Statistics regarding the adoption of a standard under this part.
Source(Aug. 14, 1935, ch. 531, title XI, § 1172, as added Pub. L. 104–191, title II, § 262(a),Aug. 21, 1996, 110 Stat. 2023.)