[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: 42CFR480.101]



[Page 482-484]

 

                         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.  480.101  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 483]]



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.  

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.

    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 484]]



    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]