[Code of Federal Regulations]
[Title 42, Volume 3, Parts 430 to end]
[Revised as of October 1, 2000]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR480.101]

[Page 392-394]
 
                         TITLE 42--PUBLIC HEALTH
 
                         CHAPTER IV--HEALTH CARE
                        FINANCING ADMINISTRATION,
                        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 Peer Review Organizations 
                                 (PROs)
 
Sec. 480.101  Scope and definitions.

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

[[Page 393]]

                           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 Peer Review Organization (PRO) (or the 
review component of a PRO subcontractor) in performance of its 
responsibilities under the Act and these regulations; and
    (2) Acquisition and maintenance of information by a PRO 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) PRO 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 PRO area.
    Patient representative means--(1) an individual designated by the 
patient, in writing, as authorized to request and receive PRO 
information that would otherwise be disclosable to that patient; or (2) 
an individual identified by the PRO 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.
    PRO deliberations means discussions or communications (within a PRO 
or between a PRO and a PRO subcontractor) including, but not limited to, 
review notes, minutes of meetings and any other records of discussions 
and judgments involving review matters regarding PRO review 
responsibilities and appeals from PRO determinations, in which the 
opinions of, or judgment about, a particular individual or institution 
can be discerned.
    PRO information means any data or information collected, acquired or 
generated by a PRO in the exercise of its duties and functions under 
Title XI Part B or Title XVIII of the Act.
    PRO 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 PRO's knowledge 
of the area gained from its medical review experience (e.g., quality 
review studies) and any other information obtained through the PRO's 
review activities.
    PRO review system means the PRO and those organizations and 
individuals who either assist the PRO 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 PRO and its officers, members and employees;
    (2) PRO subcontractors;
    (3) Health care institutions and practitioners whose services are 
reviewed;
    (4) PRO reviewers and supporting staff; and
    (5) Data support organizations.
    Public information means information which has been disclosed to the 
public.

[[Page 394]]

    Quality review study means an assessment, conducted by or for a PRO, 
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.
    Reviewer means review coordinator, physician, or other person 
authorized to perform PRO review functions.
    Sanction report means a report filed pursuant to section 1156 of the 
Act and part 474 of this chapter documenting the PRO'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 PRO 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 PRO to perform PRO review functions.

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