[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: 42CFR476.1]



[Page 464-466]

 

                         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 465]]



    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 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 466]]



    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]