---
kind: "section"
citation: "42 U.S.C. § 1320d–1"
title: "42"
title_heading: "The Public Health and Welfare"
number: "1320d–1"
heading: "General requirements for adoption of standards"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/42/1320d-1"
units:
  - "Chapter 7 — Social Security"
  - "Subchapter XI — General Provisions, Peer Review, and Administrative Simplification"
  - "Part C — Administrative Simplification"
---

# §1320d–1. General requirements for adoption of standards

- (a) **Applicability—** Any [standard](/usc/42/1320d.md?p=7) adopted under this part shall apply, in whole or in part, to the following [persons](/usc/42/1301.md?p=a-3):
  - (1) A [health plan](/usc/42/1320d.md?p=5).
  - (2) A [health care clearinghouse](/usc/42/1320d.md?p=2).
  - (3) A [health care provider](/usc/42/1320d.md?p=3) who transmits any [health information](/usc/42/1320d.md?p=4) in electronic form in connection with a transaction referred to in [section 1320d–2(a)(1) of this title](/usc/42/1320d–2.md?p=a-1).
- (b) **Reduction of costs—** Any [standard](/usc/42/1320d.md?p=7) 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)](#c-2), any [standard](/usc/42/1320d.md?p=7) adopted under this part shall be a [standard](/usc/42/1320d.md?p=7) that has been developed, adopted, or modified by a [standard setting organization](/usc/42/1320d.md?p=8).
  - (2) **Special rules—**
    - (A) **Different standards—** The [Secretary](/usc/42/1301.md?p=a-6) may adopt a [standard](/usc/42/1320d.md?p=7) that is different from any [standard](/usc/42/1320d.md?p=7) developed, adopted, or modified by a [standard setting organization](/usc/42/1320d.md?p=8), if—
      - (i) the different [standard](/usc/42/1320d.md?p=7) will substantially reduce administrative costs to [health care providers](/usc/42/1320d.md?p=3) and [health plans](/usc/42/1320d.md?p=5) compared to the alternatives; and
      - (ii) the [standard](/usc/42/1320d.md?p=7) is promulgated in accordance with the rulemaking procedures of subchapter III of chapter 5 of title 5.
    - (B) **No standard by standard setting organization—** If no [standard setting organization](/usc/42/1320d.md?p=8) has developed, adopted, or modified any [standard](/usc/42/1320d.md?p=7) relating to a [standard](/usc/42/1320d.md?p=7) that the [Secretary](/usc/42/1301.md?p=a-6) is authorized or required to adopt under this part—
      - (i) [paragraph (1)](#c-1) shall not apply; and
      - (ii) [subsection (f)](#f) shall apply.
  - (3) **Consultation requirement—**
    - (A) **In general—** A [standard](/usc/42/1320d.md?p=7) may not be adopted under this part unless—
      - (i) in the case of a [standard](/usc/42/1320d.md?p=7) that has been developed, adopted, or modified by a [standard setting organization](/usc/42/1320d.md?p=8), the organization consulted with each of the organizations described in [subparagraph (B)](#c-3-B) in the course of such development, adoption, or modification; and
      - (ii) in the case of any other [standard](/usc/42/1320d.md?p=7), the [Secretary](/usc/42/1301.md?p=a-6), in complying with the requirements of [subsection (f)](#f), consulted with each of the organizations described in [subparagraph (B)](#c-3-B) before adopting the [standard](/usc/42/1320d.md?p=7).
    - (B) **Organizations described—** The organizations referred to in [subparagraph (A)](#c-3-A) are the following:
      - (i) The National Uniform Billing Committee.
      - (ii) The National Uniform Claim Committee.
      - (iii) The Workgroup for Electronic Data Interchange.
      - (iv) The American Dental Association.
- (d) **Implementation specifications—** The [Secretary](/usc/42/1301.md?p=a-6) shall establish specifications for implementing each of the [standards](/usc/42/1320d.md?p=7) adopted under this part.
- (e) **Protection of trade secrets—** Except as otherwise required by law, a [standard](/usc/42/1320d.md?p=7) adopted under this part shall not require disclosure of trade secrets or confidential commercial information by a [person](/usc/42/1301.md?p=a-3) required to comply with this part.
- (f) **Assistance to Secretary—** In complying with the requirements of this part, the [Secretary](/usc/42/1301.md?p=a-6) shall rely on the recommendations of the National Committee on Vital and Health Statistics established under [section 242k(k) of this title](/usc/42/242k.md?p=k), and shall consult with appropriate Federal and [State agencies](/usc/42/629a.md?p=a-3) and private organizations. The [Secretary](/usc/42/1301.md?p=a-6) shall publish in the Federal Register any recommendation of the National Committee on Vital and Health Statistics regarding the adoption of a [standard](/usc/42/1320d.md?p=7) under this part.
- (g) **Application to modifications of standards—** This section shall apply to a modification to a [standard](/usc/42/1320d.md?p=7) ([including](/usc/42/1301.md?p=b) an addition to a [standard](/usc/42/1320d.md?p=7)) adopted under [section 1320d–3(b) of this title](/usc/42/1320d–3.md?p=b) in the same manner as it applies to an initial [standard](/usc/42/1320d.md?p=7) adopted under [section 1320d–3(a) of this title](/usc/42/1320d–3.md?p=a).

## Source credit

(Aug. 14, 1935, ch. 531, title XI, § 1172, as added Pub. L. 104–191, title II, § 262(a), Aug. 21, 1996, 110 Stat. 2023.)

## Notes

### Editorial Notes

### Prior Provisions

A prior section 1172 of act Aug. 14, 1935, was classified to section 1320c–21 of this title prior to the general amendment of part B of this subchapter by Pub. L. 97–248.