[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR1001.601]

[Page 1107]
 
                         TITLE 42--PUBLIC HEALTH
 
                     CHAPTER V--OFFICE OF INSPECTOR
                          GENERAL--HEALTH CARE,
                        DEPARTMENT OF HEALTH AND
                             HUMAN SERVICES
 
PART 1001--PROGRAM INTEGRITY--MEDICARE AND STATE HEALTH CARE PROGRAMS--Table of Contents
 
                    Subpart C--Permissive Exclusions
 
Sec. 1001.601  Exclusion or suspension under a Federal or State health care program.

    (a) Circumstance for exclusion. (1) The OIG may exclude an 
individual or entity suspended or excluded from participation, or 
otherwise sanctioned, under--
    (i) Any Federal program involving the provision of health care, or
    (ii) A State health care program, for reasons bearing on the 
individual's or entity's professional competence, professional 
performance or financial integrity.
    (2) The term ``or otherwise sanctioned'' in paragraph (a)(1) of this 
section is intended to cover all actions that limit the ability of a 
person to participate in the program at issue regardless of what such an 
action is called, and includes situations where an individual or entity 
voluntarily withdraws from a program to avoid a formal sanction.
    (b) Length of exclusion. (1) An exclusion imposed in accordance with 
this section will not be for a period of time less than the period 
during which the individual or entity is excluded or suspended from a 
Federal or State health care program.
    (2) Any of the following factors may be considered aggravating and a 
basis for lengthening the period of exclusion--
    (i) The acts that resulted in the exclusion, suspension or other 
sanction under Medicare, Medicaid and all other Federal health care 
programs had, or could have had, a significant adverse impact on Federal 
or State health care programs or the beneficiaries of those programs or 
other individuals;
    (ii) Whether the individual or entity has a documented history of 
criminal, civil or administrative wrongdoing; or
    (iii) The individual or entity has been the subject of any other 
adverse action by any Federal, State or local government agency or 
board, if the adverse action is based on the same set of circumstances 
that serves as the basis for the imposition of the exclusion.
    (3) Only if any of the aggravating factors set forth in paragraph 
(b)(2) of this section justifies a longer exclusion may mitigating 
factors be considered as a basis for reducing the period of exclusion to 
a period not less than that set forth in paragraph (b)(1) of this 
section. Only the following factors may be considered mitigating--
    (i) The individual's or entity's cooperation with Federal or State 
officials resulted in--
    (A) The sanctioning of other individuals or entities, or
    (B) Additional cases being investigated or reports being issued by 
the appropriate law enforcement agency identifying program 
vulnerabilities or weaknesses; or
    (ii) Alternative sources of the types of health care items or 
services furnished by the individual or entity are not available.
    (4) If the individual or entity is eligible to apply for 
reinstatement in accordance with Sec. 1001.3001 of this part, and the 
sole reason for the State denying reinstatement is the existing Medicare 
exclusion imposed by the OIG as a result of the original State action, 
the OIG will consider a request for reinstatement.

[57 FR 3330, Jan. 29, 1992, as amended at 63 FR 46688, Sept. 2, 1998]