[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR480.140]

[Page 477]
 
                         TITLE 42--PUBLIC HEALTH
 
  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 
                  HEALTH AND HUMAN SERVICES (CONTINUED)
 
PART 480_ACQUISITION, PROTECTION, AND DISCLOSURE QUALITY IMPROVEMENT 
ORGANIZATION INFORMATION--Table of Contents
 
     Subpart B_Utilization and Quality Control Quality Improvement 
                          Organizations (QIOs)
 
Sec. 480.140  Disclosure of quality review study information.

    (a) A QIO must disclose, onsite, 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; 
CMS; 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 recipient of the information.
    (2) The recipient 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.

[50 FR 15359, Apr. 17, 1985. Redesignated at 64 FR 66279, Nov. 24, 1999, 
as amended at 69 FR 49266, Aug. 11, 2004]