C.F.R. » Title 42 » CHAPTER V—OFFICE OF INSPECTOR GENERAL-HEALTH CARE, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER B—OIG AUTHORITIES › PART 1004—IMPOSITION OF SANCTIONS ON HEALTH CARE PRACTITIONERS AND PROVIDERS OF HEALTH CARE SERVICES BY A QUALITY IMPROVEMENT ORGANIZATION › Subpart A—General Provisions

42 C.F.R. § 1004.1

Scope and definitions

Read at: eCFRecfr.gov CornellLII GovInfogovinfo.gov CasesGoogle Scholar

(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.

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.

Notes of Decisions
Cited in 7 cases, 1987–1998 · leading case: Nermin D. Lavapies, M.D. v. Otis R. Bowen, M.D., 883 F.2d 465 (6th Cir. 1989).
Sort: Relevance Newest Treatment
Nermin D. Lavapies, M.D. v. Otis R. Bowen, M.D., 883 F.2d 465 (6th Cir. 1989). · cites it 2× “The regulations define a “gross and flagrant” violation as a violation of an obligation [which] has occurred in one or more instances which presents an imminent danger to the health, safety or well-being of a Medicare beneficiary or places the beneficiary unnecessarily in…”
Varandani v. Bowen, 824 F.2d 307 (4th Cir. 1987). · cites it 2× “42 C.F.R. § 1004.1 (b) (1986), formerly codified at 42 C.”
Lavapies v. Bowen, 687 F. Supp. 1193 (S.D. Ohio 1988). “This definition tracks the definition of gross and flagrant violation contained in 42 C.F.R. § 1004.1 (b). Plaintiff does not suggest that there was any defect in the rule-making process with respect to that definition.”
Winter v. California Med. Review, Inc., 900 F.2d 1322 (9th Cir. 1989). “An extensive framework for administrative review of PRO decisions is set forth in 42 C.F.R. §§ 1004.1 — 1004.130 (1988). In such cases as the present one, the practitioner under investigation may meet with and provide additional information to the PRO after the PRO has made its…”
Doyle v. Bowen, 660 F. Supp. 1484 (D. Me. 1987). “Plaintiff argues that he could not be expected to know what would constitute a “gross and flagrant” violation of his obligation to provide medical treatment “of a quality which meets professionally recognized standards of health care.”
Corkill v. Shalala, 109 F.3d 1348 (9th Cir. 1997). “” 42 C.F.R. § 1004.1 (b). The regulations do not require CMRI to take a random sample; they only require CMRI to establish a pattern.”
Armstrong v. Dwyer, 155 F.3d 211 (3rd Cir. 1998). “” 42 C.F.R. § 1004.1 . The latter means "a pattern of providing care .”
Annotations are extracted automatically from the opinions in the Syfert caselaw corpus and ranked by authority, recency, and treatment. Dots show Syfertize treatment of the citing case itself.