[Code of Federal Regulations]
[Title 42, Volume 2]
[Revised as of October 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR402.308]

[Page 42-43]
 
                         TITLE 42--PUBLIC HEALTH
 
                             HUMAN SERVICES
 
PART 402_CIVIL MONEY PENALTIES, ASSESSMENTS, AND EXCLUSIONS--Table of 
Contents
 
                          Subpart C_Exclusions
 
Sec.  402.308  Waivers of exclusions.

    (a) Basis. Section 1128(c)(3)(B) of the Act specifies that in the 
case of an exclusion from participation in the Medicare program based 
upon section 1128(a)(1), (a)(3), or (a)(4) of the Act, the individual 
may request that CMS present, on his or her behalf, a request to the OIG 
for a waiver of the exclusion.
    (b) Definitions. For purposes of this section:
    Excluded person has the same meaning as a ``person'' as defined in 
Sec.  402.3 who meets for the purposes of this subpart, the definition 
of the term ``exclusion'' in Sec.  402.3.
    Hardship for purposes of this section means something that 
negatively affects Medicare beneficiaries and results from the 
imposition of an exclusion because the excluded person is the sole 
community physician or sole source of essential specialized services in 
the Medicare community.
    Sole community physician has the same meaning as that term is 
defined Sec.  1001.2 of this title.
    Sole source of essential specialized services in the community has 
the same meaning as that term defined by the Sec.  1001.2 of this title.
    (c) General rule. If CMS determines that a hardship as defined in 
paragraph (b)(2) of this section results from exclusion of an affected 
person from the Medicare program, CMS may consider and may make a 
request to the Inspector General for waiver of the Medicare exclusion.
    (d) Submission and content of a waiver of exclusion request. An 
excluded person must submit a request for waiver of exclusion in writing 
to CMS that includes the following:
    (1) A copy of the exclusion notice from the OIG.
    (2) A statement requesting that CMS present a waiver of exclusion 
request to the OIG on his or her behalf.
    (3) A statement that he or she is the sole community physician or 
sole source of essential specialized services in the community.
    (4) Documentation to support the statement in paragraph (d)(3) of 
this section.
    (e) Processing of waiver of exclusion requests. CMS processes a 
request for a waiver of exclusion as follows:
    (1) Notifies the submitter that the waiver of exclusion request has 
been received.
    (2) Reviews and validates all submitted documents.
    (3) During its analysis, CMS may require additional, specific 
information, and authorization to obtain information from private health 
insurers, peer review organizations (including, but not limited to, 
Quality Improvement Organizations), and others as necessary to determine 
validity.
    (4) Makes a determination regarding whether or not to submit the 
waiver of exclusion request to the OIG based on review and validation of 
the submitted documents.
    (5) If CMS elects to submit the waiver of exclusion request to the 
OIG, CMS copies the excluded person on the request.

[[Page 43]]

    (6) If CMS denies the request, then CMS notifies the excluded person 
of the decision and specifies the reason(s) for the decision.
    (f) Administrative or judicial review. A determination rendered 
under paragraph (e)(4) of this section is not subject to administrative 
or judicial review.