§ 476.1 Definitions. As used in this part, unless the context indicates otherwise: *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.
*Appointed representative* means an individual appointed by a Medicare beneficiary to represent the beneficiary in the beneficiary complaint review process.
*Authorized representative* means an individual authorized, under State or other applicable law, to act on behalf of a Medicare beneficiary. An authorized representative has all of the rights and responsibilities of a Medicare beneficiary throughout the processing of a beneficiary complaint.
*Beneficiary complaint* means a complaint by a Medicare beneficiary or a Medicare beneficiary's representative alleging that the quality of Medicare covered services received by the beneficiary did not meet professionally recognized standards of care. A complaint may consist of one or more quality of care concerns.
*Beneficiary complaint review* means a review conducted by a QIO in response to the receipt of a written beneficiary complaint to determine whether the quality of Medicare covered services provided to the beneficiary was consistent with professionally recognized standards of health care.
*Beneficiary representative* means an individual identified as an authorized or appointed representative of a Medicare beneficiary.
*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.
*Five percent or more owner* means a person (including, where appropriate, a corporation) who: ( 1 ) Has an ownership interest of 5 percent or more;
( 2 ) Has an indirect ownership interest equal to 5 percent or more;
( 3 ) 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
( 4 ) 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.
*General quality of care review* means a review conducted by a QIO to determine whether the quality of Medicare covered services provided to a Medicare beneficiary was consistent with professionally recognized standards of health care. A general quality of care review may be carried out as a result of a referral to the QIO or a QIO's identification of a potential concern during the course of another review activity or through the analysis of data.
*Gross and flagrant violation* means a violation of an obligation resulting from inappropriate or unnecessary services, services that do not meet recognized professional standards of care, or services that are not supported by evidence of medical necessity or quality as required by the QIO. The violation must have occurred in one or more instances that present an imminent danger to the health, safety, or well-being of a program patient or places the program patient unnecessarily in high-risk situations.
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 § 440.170(b) of this chapter.
*Immediate advocacy* means an informal alternative dispute resolution process used to quickly resolve an oral complaint a Medicare beneficiary or his or her representation has regarding the quality of Medicare covered health care received. This process involves a QIO representative's direct contact with the provider and/or practitioner.
*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: ( 1 ) A doctor or medicine or osteopathy, a doctor of dental surgery or dental medicine, a doctor of podiatry, a doctor of optometry, or a chiropractor, as described in section 1861(r) of the Act;
( 2 ) An intern, resident, or Federal Government employee authorized under State or Federal law to practice as a doctor as described in paragraph (1) of this definition; and
( 3 ) An individual licensed to practice as a doctor as described in paragraph (1) of this definition in any Territory or Commonwealth of the United States of America.
*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 or the Medicare administrative contractor, 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.
*Provider* means a health care facility, institution, or organization, including but not limited to a hospital, involved in the delivery of health care services for which payment may be made in whole or in part under Title XVIII of the Act.
*QIO review* means review performed in fulfillment of a contract with CMS, either by the QIO or its subcontractors.
*Quality improvement initiative* means any formal activity designed to serve as a catalyst and support for quality improvement that uses proven methodologies to achieve these improvements. The improvements may relate to safety, health care, health and value and involve providers, practitioners, beneficiaries, and/or communities.
*Quality of care concern* means a concern that care provided did not meet a professionally recognized standard of health care. A general quality of care review or a beneficiary complaint review may cover a single or multiple concerns.
*Quality of care review* means a review conducted by a QIO to determine whether the quality of Medicare covered services provided to beneficiaries was consistent with professionally recognized standards of health care. A quality of care review can either be a beneficiary complaint review or a general quality of care review.
*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.
*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.
*Significant quality of care concern* means a determination by the QIO that the quality of care provided to a Medicare beneficiary did not meet the standard of care and, while not a gross and flagrant or substantial violation of the standard, represents a noticeable departure from the standard that could reasonably be expected to have a negative impact on the health of a beneficiary.
*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 § 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.
*Substantial violation in a substantial number of cases* means a pattern of providing care that is inappropriate, unnecessary, or does not meet recognized professional standards of care, or is not supported by the necessary documentation of care as required by the QIO.
*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; 77 FR 53682, Aug. 31, 2012; 77 FR 68559, Nov. 15, 2012; 78 FR 75199, Dec. 10, 2013]