Title 42

SECTION 480.140

480.140 Disclosure of quality review study information.

§ 480.140 Disclosure of quality review study information.

(a) A QIO must disclose quality review study information with identifiers of patients, practitioners or institutions to -

(1) Representatives of authorized licensure, accreditation or certification agencies as is required by the agencies in carrying out functions which are within the jurisdiction of such agencies under state law; to Federal and State agencies responsible for identifying risks to the public health when there is substantial risk to the public health; or to Federal and State fraud and abuse enforcement agencies;

(2) An institution or practitioner, if the information is limited to health care services furnished by the institution or practitioner; and

(3) A medical review board established under section 1881 of the Act pertaining to end-stage renal disease facilities, if the information is limited to health care services subject to its review.

(b) A QIO must disclose quality review study information with identifiers of patients, practitioners or institutions to the Office of the Inspector General and the General Accounting Office as necessary to carry out statutory responsibilities.

(c) A QIO may disclose information offsite from a particular quality review study to any institution or practitioner involved in that study, provided the disclosed information is limited to that institution or practitioner.

(d) A QIO may disclose quality review study information with identifiers of particular practitioners or institutions, or both, at the written request of, or with the written consent of, the identified practitioner(s) or institution(s).

(1) The consent or request must specify the information that is to be disclosed and the intended beneficiary of the information.

(2) The beneficiary of the information has the same redisclosure rights and responsibilities as the requesting or consenting practitioner or institution as provided under this Subpart B.

(e) An institution or group of practitioners may redisclose quality review study information, if the information is limited to health care services they provided.

(f) Quality review study information with patient identifiers is not subject to subpoena or discovery in a civil action, including an administrative, judicial or arbitration proceeding. This restriction does not apply to HHS, including Inspector General, administrative subpoenas issued in the course of audits and investigations of Department programs, in the course of administrative hearings held under the Social Security Act, or to disclosures to the General Accounting Office as necessary to carry out its statutory responsibilities.

(g) A QIO must disclose quality review study information to CMS with identifiers of patients, practitioners or institutions -

(1) For purposes of quality improvement. Activities include, but are not limited to, data validation, measurement, reporting, and evaluation.

(2) As requested by CMS when CMS deems it necessary for purposes of overseeing and planning QIO program activities.

[50 FR 15359, Apr. 17, 1985. Redesignated at 64 FR 66279, Nov. 24, 1999, as amended at 69 FR 49266, Aug. 11, 2004; 75 FR 19826, Apr. 15, 2010; 76 FR 26547, May 6, 2011]

---