§ 480.101 Scope and definitions. ( 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 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 § 480.132(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.
*Public information* means information which has been disclosed to the public.
*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;
( 5 ) Data support organizations; and
( 6 ) CMS.
*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.
*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; 69 FR 49267, Aug. 11, 2004; 76 FR 26546, May 6, 2011]