[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: 42CFR1004.1]



[Page 1188-1189]

 

                         TITLE 42--PUBLIC HEALTH

 

      GENERAL--HEALTH CARE, DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

PART 1004_IMPOSITION OF SANCTIONS ON HEALTH CARE PRACTITIONERS AND 

 

                      Subpart A_General Provisions

 

Sec.  1004.1  Scope and definitions.





    (a) Scope. This part implements section 1156 of the Act by--

    (1) Setting forth certain obligations imposed on practitioners and 

providers of services under Medicare;

    (2) Establishing criteria and procedures for the reports required 

from quality improvement organizations (QIOs) when there is failure to 

meet those obligations;

    (3) Specifying the policies and procedures for making determinations 

on violations and imposing sanctions; and

    (4) Defining the procedures for appeals by the affected party and 

the procedures for reinstatements.

    (b) Definitions. As used in this part, unless the context indicates 

otherwise--

    Dentist is limited to licensed doctors of dental surgery or dental 

medicine.

    Economically means the services are provided at the least expensive, 

medically appropriate type of setting or level of care available.

    Exclusion means that items and services furnished or ordered (or at 

the medical direction or on the prescription of a physician) by a 

specified health care practitioner, provider or other person during a 

specified period are not reimbursed under titles V, XVIII, XIX, or XX of 

the Social Security Act and all other Federal non-procurement programs.

    Gross and flagrant violation means a violation of an obligation has 

occurred in one or more instances which presents 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 service or services means services or items for which 

payment may be made (in whole or in part) under the Medicare or State 

health care programs.

    Health professional shortage area (HPSA) means an area designated by 

the Secretary and defined in 42 CFR 5.2.

    Metropolitan Statistical Area means an area as defined by the 

Executive Office of Management and Budget.



[[Page 1189]]



    Obligation means any of the obligations specified at section 1156(a) 

of the Act.

    Other person means a hospital or other health care facility, an 

organization or an agency that provides health care services or which 

payment may be made (in whole or in part) under the Medicare or State 

health care programs.

    Pattern or care means that the care under question has been 

demonstrated in more than three instances, each of which involved 

different admissions.

    Pharmacy professional is a term limited to individuals who are 

licensed or registered to provide pharmaceutical services.

    Podiatric professional is a term limited to licensed doctors of 

podiatric medicine.

    Practice area means the location where over 50 percent of the 

practitioner's or other person's patients are seen.

    Practitioner means a physician or other health care professional 

licensed under State law to practice his or her profession.

    Primary medical care professional is a term limited to:

    (i) Licensed doctors of medicine and doctors of osteopathy providing 

direct patient care who practice in the fields of general or family 

practice, general internal medicine, pediatrics, obstetrics and 

gynecology, surgery, and any other specialty that is not accommodated by 

the remaining specialty HPSA designator, or

    (ii) Those facilities where care and treatment is provided to 

patients with health problems other than mental disorders.

    Pro area means the geographic area subject to review by a particular 

QIO.

    Provider means a hospital or other health care facility, agency, or 

organization.

    Psychiatric professional is a term limited to licensed doctors of 

medicine who limit their practice to psychiatry or to those facilities 

where care and treatment is limited to patients with mental disorders.

    Rural means any area outside an urban area.

    Rural health professional shortage area means any health 

professional shortage area located outside a Metropolitan Statistical 

Area.

    Sanction means an exclusion or monetary penalty that the Secretary 

may impose on a practitioner or other person as a result of a 

recommendation from a QIO.

    Serious risk includes situations that may involve the risk of 

unnecessary treatment, prolonged treatment, lack of treatment, incorrect 

treatment, medical complication, premature discharge, physiological or 

anatomical impairment, disability, or death.

    State health care program means a State plan approved under title 

XIX, any program receiving funds under title V or from an allotment to a 

State under such title, or any program receiving funds under title XX or 

from an allotment to a State under such title.

    Substantial violation in a substantial number of cases means a 

pattern of providing care, as defined in this section, 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.

    Urban means a Metropolitan Statistical Area as defined by the 

Executive Office of Management and Budget.

    Vision care professional is a term limited to licensed doctors of 

medicine who limit their practice to ophthalmology and to doctors of 

optometry.