45 C.F.R. § 60.16

Reporting other adjudicated actions or decisions

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(a) Who must report. Federal Government agencies, state law or fraud enforcement agencies, and health plans must report other adjudicated actions or decisions as defined in § 60.3 of this part related to the delivery, payment or provision of a health care item or service against health care practitioners, providers, and suppliers (regardless of whether the other adjudicated action or decision is subject to a pending appeal).

(b) What information must be reported. Entities described in paragraph (a) of this section must report the information as required in § 60.15(b) of this part.

(c) What information may be reported, if known. Entities described in paragraph (a) of this section should report, if known, the information as described in § 60.15(c) of this part.

(d) Access to documents. Each state must provide the Secretary (or an entity designated by the Secretary) with access to the documents underlying the actions described in paragraphs (a)(1) through (4) of this section, as may be necessary for the Secretary to determine the facts and circumstances concerning the actions and determinations for the purpose of carrying out section 1921.

(e) Sanctions for failure to report. Any health plan that fails to report information on another adjudicated action or decision required to be reported under this section will be subject to a civil money penalty (CMP) of not more than $25,000 for each such action not reported. Such penalty will be imposed and collected in the same manner as CMPs under subsection (a) of section 1128A of the Social Security Act. The Secretary will provide for publication of a public report that identifies those government agencies that have failed to report information on other adjudicated actions as required to be reported under this section.

Notes of Decisions

Cited in 5 cases (1 in the last 5 years), 2010–2025 · leading case: Leal v. Sec'y, Us Dept. of Hhs, 620 F.3d 1280 (11th Cir. 2010).

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Leal v. Sec'y, Us Dept. of Hhs, 620 F.3d 1280 (11th Cir. 2010). · cites it 2× “Under those regulations, a physician who disputes the accuracy of a report can seek Secretarial review, see 45 C.F.R. § 60.16 (c)(2), which is limited to having the report reviewed "for accuracy of factual information and to ensure that the information was required to be…”

Leal v. Sec'y, U.S. Dep't of Health & Human Servs., 620 F.3d 1280 (11th Cir. 2010). · cites it 2× “In the Health Care Quality Improvement Act, Congress directed the Secretary of the Department of Health & Human Services to promulgate regulations establishing “procedures in the case of disputed accuracy of the information” in the National Practitioner Data Bank.”

Reynolds v. United States Dep't of Just., 10 F. Supp. 3d 134 (D.D.C. 2014). “” 45 C.F.R. § 60.16 (a); 45 C.F.R. § 60.3 .”

Hoedt v. Vanderbilt Univ. (M.D. Tenn. 2025). “; see 45 C.F.R. § 60.16 (c)(2). The Secretary’s review is “limited to having the report reviewed for accuracy of factual information and to ensure that the information was required to be reported.”

David H. McCord v. HCA Health Servs. of Tennessee, Inc. (Tenn. Ct. App. 2015). “The language of the regulation is permissive; a practitioner is not required to avail himself or herself of the administrative process in order to dispute the accuracy of the NPDB report. The court erred in so holding and granting the rule 12.”

— 45 C.F.R. § 60.16(b) — 1 case

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