[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: 42CFR1001.401]



[Page 1127-1128]

 

                         TITLE 42--PUBLIC HEALTH

 

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

 

PART 1001_PROGRAM INTEGRITY_MEDICARE AND STATE HEALTH CARE PROGRAMS--

 

                     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



[[Page 1128]]



other individuals or the Medicare, Medicaid or other Federal health care 

programs;

    (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]