[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR480.101]

[Page 463-465]
 
                         TITLE 42--PUBLIC HEALTH
 
  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 
                 HEALTH AND HUMAN SERVICES--(Continued)
 
PART 480--ACQUISITION, PROTECTION, AND DISCLOSURE OF PEER REVIEW INFORMATION--Table of Contents
 
     Subpart B--Utilization and Quality Control Quality Improvement 
                          Organizations (QIOs)
 
Sec. 480.101  Scope and definitions.

    Source: 50 FR 15359, Apr. 17, 1985, unless otherwise noted. 
Redesignated at 64 FR 66279, Nov. 24, 1999.

                           General Provisions


    (a) Scope. This subpart sets forth the policies and procedures 
governing--
    (1) Disclosure of information collected, acquired or generated by a 
Utilization and Quality Control Quality Improvement Organization (QIO) 
(or

[[Page 464]]

the review component of a QIO subcontractor) in performance of its 
responsibilities under the Act and these regulations; and
    (2) Acquisition and maintenance of information by a QIO to comply 
with its responsibilities under the Act.
    (b) Definitions. As used in this part:
    Abuse means any unlawful conduct relating to items or services for 
which payment is sought under Title XVIII of the Act.
    Aggregate statistical data means any utilization, admission, 
discharge or diagnostic related group (DRG) data arrayed on a 
geographic, institutional or other basis in which the volume and 
frequency of services are shown without identifying any individual.
    Confidential information means any of the following:
    (1) Information that explicitly or implicitly identifies an 
individual patient, practitioner or reviewer.
    (2) Sanction reports and recommendations.
    (3) Quality review studies which identify patients, practitioners or 
institutions.
    (4) QIO deliberations.
    Health care facility or facility means an organization involved in 
the delivery of health care services or items for which reimbursement 
may be made in whole or in part under Title XVIII of the Act.
    Implicitly identify(ies) means data so unique or numbers so small so 
that identification of an individual patient, practitioners or reviewer 
would be obvious.
    Non-facility organization means a corporate entity that: (1) Is not 
a health care facility; (2) is not a 5 percent or more owner of a 
facility; and (3) is not owned by one or more health care facilities in 
the QIO area.
    Patient representative means--(1) an individual designated by the 
patient, in writing, as authorized to request and receive QIO 
information that would otherwise be disclosable to that patient; or (2) 
an individual identified by the QIO in accordance with 
Sec. 476.132(c)(3) when the beneficiary is mentally, physically or 
legally unable to designate a representative.
    Practitioner means an individual credentialed within a recognized 
health care discipline and involved in providing the services of that 
discipline to patients.
    QIO deliberations means discussions or communications (within a QIO 
or between a QIO and a QIO subcontractor) including, but not limited to, 
review notes, minutes of meetings and any other records of discussions 
and judgments involving review matters regarding QIO review 
responsibilities and appeals from QIO determinations, in which the 
opinions of, or judgment about, a particular individual or institution 
can be discerned.
    QIO information means any data or information collected, acquired or 
generated by a QIO in the exercise of its duties and functions under 
Title XI Part B or Title XVIII of the Act.
    QIO interpretations and generalizations on the quality of health 
care means an assessment of the quality of care furnished by an 
individual provider or group of providers based on the QIO's knowledge 
of the area gained from its medical review experience (e.g., quality 
review studies) and any other information obtained through the QIO's 
review activities.
    QIO review system means the QIO and those organizations and 
individuals who either assist the QIO or are directly responsible for 
providing medical care or for making determinations with respect to the 
medical necessity, appropriate level and quality of health care services 
that may be reimbursed under the Act. The system includes--
    (1) The QIO and its officers, members and employees;
    (2) QIO subcontractors;
    (3) Health care institutions and practitioners whose services are 
reviewed;
    (4) QIO reviewers and supporting staff; and
    (5) Data support organizations.
    Public information means information which has been disclosed to the 
public.
    Quality review study means an assessment, conducted by or for a QIO, 
of a patient care problem for the purpose of improving patient care 
through peer analysis, intervention, resolution of the problem and 
follow-up.
    Quality review study information means all documentation related to 
the quality review study process.

[[Page 465]]

    Reviewer means review coordinator, physician, or other person 
authorized to perform QIO review functions.
    Sanction report means a report filed pursuant to section 1156 of the 
Act and part 474 of this chapter documenting the QIO's determination 
that a practitioner or institution has failed to meet obligations 
imposed by section 1156 of the Act.
    Shared health data system means an agency or other entity authorized 
by Federal or State law that is used by the QIO review system to provide 
information or to conduct or arrange for the collection, processing, and 
dissemination of information on health care services.
    Subcontractor means a facility or a non-facility organization under 
contract with a QIO to perform QIO review functions.

[50 FR 15359, Apr. 17, 1985; 50 FR 41886, Oct. 16, 1985. Redesignated at 
64 FR 66279, Nov. 24, 1999]