[Code of Federal Regulations]

[Title 42, Volume 4]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR480.140]



[Page 492]

 

                         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 

 

     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]