[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR1001.401]

[Page 1115-1116]
 
                         TITLE 42--PUBLIC HEALTH
 
      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. 1001.401  Conviction relating to controlled substances.

    (a) Circumstance for exclusion. The OIG may exclude an individual or 
entity convicted under Federal or State law of a misdemeanor relating to 
the unlawful manufacture, distribution, prescription or dispensing of a 
controlled substance, as defined under Federal or State law. This 
section applies to any individual or entity that--
    (1) Is, or has ever been, a health care practitioner, provider or 
supplier;
    (2) Holds or has held a direct or indirect ownership or control 
interest, as defined in section 1124(a)(3) of the Act, in an entity that 
is a health care provider or supplier, or is or has been an officer, 
director, agent or managing employee, as defined in section 1126(b) of 
the Act, of such an entity; or
    (3) Is, or has ever been, employed in any capacity in the health 
care industry.
    (b) For purposes of this section, the definition of controlled 
substance will be the definition that applies to the law forming the 
basis for the conviction.
    (c) Length of exclusion. (1) An exclusion imposed in accordance with 
this section will be for a period of 3 years, unless aggravating or 
mitigating factors listed in paragraphs (b)(2) and (b)(3) of this 
section form a basis for lengthening or shortening that period.
    (2) Any of the following factors may be considered to be aggravating 
and a basis for lengthening the period of exclusion--
    (i) The acts that resulted in the conviction or similar acts were 
committed over a period of one year or more;
    (ii) The acts that resulted in the conviction or similar acts had a 
significant adverse mental, physical or financial impact on program 
beneficiaries or other individuals or the Medicare, Medicaid or other 
Federal health care programs;

[[Page 1116]]

    (iii) The sentence imposed by the court included incarceration;
    (iv) Whether the individual or entity has a documented history of 
criminal, civil or administrative wrongdoing; or
    (v) Whether the individual or entity was convicted of other offenses 
besides those which formed the basis for the exclusion, or has been the 
subject of any other adverse action by any other 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 the following factors may be considered as mitigating and a 
basis for shortening the period of exclusion--
    (i) The individual's or entity's cooperation with Federal or State 
officials resulted in--
    (A) Others being convicted or excluded from Medicare, Medicaid and 
all other Federal health care programs,
    (B) Additional cases being investigated or reports being issued by 
the appropriate law enforcement agency identifying program 
vulnerabilities or weaknesses, or
    (C) The imposition of a civil money penalty against others; or
    (ii) Alternative sources of the type of health care items or 
services furnished by the individual or entity are not available.

[57 FR 3330, Jan. 29, 1992, as amended at 63 FR 46687, Sept. 2, 1998; 64 
FR 39426, July 22, 1999]