[Code of Federal Regulations]
[Title 12, Volume 1]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR476.1]

[Page 449-451]
 
                         TITLE 42--PUBLIC HEALTH
 
  CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF 
                 HEALTH AND HUMAN SERVICES--(Continued)
 
PART 476--UTILIZATION AND QUALITY CONTROL REVIEW--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 476.1  Definitions.


    As used in this part, unless the context indicates otherwise:
    Active staff privileges means: (a) That a physician is authorized on 
a regular, rather than infrequent or courtesy, basis: (1) to order the 
admission of patients to a facility; (2) to perform diagnostic services 
in a facility; or (3) to care for and treat patients in a facility; or 
(b) that a health care practitioner other than a physician is authorized 
on a regular, rather than infrequent or courtesy, basis to order the 
admission of patients to a facility.
    Admission review means a review and determination by a QIO of the 
medical necessity and appropriateness of a patient's admission to a 
specific facility.
    Continued stay review means QIO review that is performed after 
admission review and during a patient's hospitalization to determine the 
medical necessity and appropriateness of continuing the patient's stay 
at a hospital level of care.
    Criteria means predetermined elements of health care, developed by 
health professionals relying on professional expertise, prior 
experience, and the professional literature, with which aspects of the 
quality, medical necessity, and appropriateness of a health care service 
may be compared.
    Diagnosis related group (DRG) means a system for classifying 
inpatient hospital discharges. DRGs are used for purposes of determining 
payment to hospitals for inpatient hospital services under the Medicare 
prospective payment system.
    DRG validation means a part of the prospective payment system in 
which a QIO validates that DRG assignments are based on the correct 
diagnostic and procedural information.
    Elective, when applied to admission or to a health care service, 
means an admission or a service that can be delayed without substantial 
risk to the health of the individual.

[[Page 450]]

    Five percent or more owner means a person (including, where 
appropriate, a corporation) who:
    (a) Has an ownership interest of 5 percent or more;
    (b) Has an indirect ownership interest equal to 5 percent or more;
    (c) Has a combination of direct and indirect ownership interests 
(the possession of equity in the capital, the stock, or the profits of 
an entity) equal to five percent or more; or
    (d) Is the owner of an interest of five percent or more in any 
obligation secured by an entity, if the interest equals at least five 
percent of the value of the property or assets of the entity.
    Health care facility or facility means an organization involved in 
the delivery of health care services for which reimbursement may be made 
in whole or in part under Title XVIII of the Act.
    Health care practitioners other than physicians means those health 
professionals who do not hold a doctor of medicine or doctor of 
osteopathy degree, who meet all applicable State or Federal requirements 
for practice of their professions, and who are in active practice.
    Hospital means a health care institution or distinct part of a 
health care institution, as defined in Section 1861(e)-(g) of the Act, 
other than a a religious nonmedical institution as defined in Sec. 
440.170(b) of this chapter.
    Initial denial determination means an initial negative decision by a 
QIO, regarding the medical necessity, quality, or appropriateness of 
health care services furnished, or proposed to be furnished, to a 
patient.
    Major clinical area means medicine, surgery, pediatrics, obstetrics 
and gynecology, or psychiatry.
    Major procedure means a diagnostic or therapeutic procedure which 
involves a surgical or anesthetic risk or requires highly trained 
personnel or special facilities or equipment.
    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 or 
association of facilities in the QIO area.
    Norm means a pattern of performance in the delivery of health care 
services that is typical for a specified group.
    Norms means numerical or statistical measures of average observed 
performance in the delivery of health care services.
    Outliers means those cases that have either an extremely long length 
of stay or extraordinarily high costs when compared to most discharges 
classified in the same DRG.
    Peer review means review by health care practitioners of services 
ordered or furnished by other practitioners in the same professional 
field.
    Physician means a doctor of medicine or osteopathy or another 
individual who is authorized under State or Federal law to practice 
medicine and surgery, or osteopathy. This includes medical officers in 
American Samoa, the Northern Mariana Islands, and the Trust Territory of 
the Pacific Islands.
    Practitioner means an individual credentialed within a recognized 
health care discipline and involved in providing the services of that 
discipline to patients.
    Preadmission certification means a favorable determination, 
transmitted to the hospital and the fiscal intermediary, approving the 
patient's admission for payment purposes.
    Preadmission review means review prior to a patient's admission to a 
hospital to determine, for payment purposes, the reasonableness, medical 
necessity and appropriateness of placement at an acute level of care.
    Preprocedure review means review of a surgical or other invasive 
procedure prior to the conduct of the procedure.
    QIO review means review performed in fulfillment of a contract with 
CMS, either by the QIO or its subcontractors.
    Profile means aggregated data in formats that display patterns of 
health care services over a defined period of time.
    Profile analysis means review and analysis of profiles to identify 
and consider patterns of health care services.
    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.

[[Page 451]]

    Regional norms, criteria, and standards means norms, criteria, and 
standards that apply to a geographic division which is larger than a QIO 
area.
    Retrospective review means review that is conducted after services 
are provided to a patient. The review is focused on determining the 
appropriateness, necessity, quality, and reasonableness of health care 
services provided.
    Review responsibility means (1) the responsibility of the QIO to 
perform review functions prescribed under Part B of Title XI of the Act 
and the Social Security Amendments of 1983 (Pub. L. No. 98-21) and the 
regulations of this part; (2) the responsibility to fulfill the terms 
and meet the objectives set forth in the negotiated contract between CMS 
and the QIO; and (3) the authority of a QIO to make conclusive initial 
denial determinations regarding the medical necessity and 
appropriateness of health care and changes as a result of DRG 
validations.
    Skilled nursing facility (SNF) means a health care institution or 
distinct part of an institution that (a) is primarily engaged in 
providing skilled nursing care or rehabilitative services to injured, 
disabled, or sick persons, and (b) has an agreement to participate in 
Medicare or Medicaid or both, and (c) is not a religious nonmedical 
institution as defined in Sec. 440.170(b) of this chapter
    Standards means professionally developed expressions of the range of 
acceptable variation from a norm or criterion.
    Subcontractor means a facility or a non-facility organization under 
contract with a QIO to perform QIO review functions.
    Working day means any one of at least five days of each week 
(excluding, at the option of each QIO, legal holidays) on which the 
necessary personnel are available to perform review.

[44 FR 32081, June 4, 1979, as amended at 45 FR 67545, Oct. 10, 1980; 46 
FR 48569, Oct. 1, 1981. Redesignated and amended at 50 FR 15328, 15329, 
Apr. 17, 1985; 51 FR 43197, Dec. 1, 1986. Redesignated at 64 FR 66279, 
Nov. 24, 1999, as amended at 64 FR 67052, Nov. 30, 1999]

Subpart B [Reserved]