[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: 42CFR1004.140]

[Page 1170-1172]
 
                         TITLE 42--PUBLIC HEALTH
 
                     CHAPTER V--OFFICE OF INSPECTOR
                          GENERAL--HEALTH CARE,
                        DEPARTMENT OF HEALTH AND
                             HUMAN SERVICES
 
PART 1004--IMPOSITION OF SANCTIONS ON HEALTH CARE PRACTITIONERS AND PROVIDERS OF HEALTH CARE SERVICES BY A QUALITY IMPROVEMENT ORGANIZATION--Table of Contents
 
                           Subpart F--Appeals
 
Sec. 1004.140  Appeal rights.


    (a) Right to preliminary hearing. (1)(i) A practitioner or other 
person excluded from participation in Medicare and any State health care 
programs under section 1156 of the Act may request a preliminary hearing 
if the location where services are rendered to over 50 percent of the 
practitioner's or other person's patients at the time of the exclusion 
notice is in a rural HPSA or in a county with a population of less than 
70,000.
    (ii) Unless the practitioner's or other person's practice meets the 
definition for psychiatric professional, vision care professional, 
dental professional, podiatric professional or pharmacy professional, 
the HPSA used by the OIG for determination of entitlement to a 
preliminary hearing will be the HPSA list for primary medical care 
professional.
    (iii) Information on the population size of a county in order to 
determine entitlement to a preliminary hearing will be obtained by the 
OIG from the responsible officials of that county.
    (2)(i) A request for a preliminary hearing must be made in writing 
and received by the Departmental Appeals Board (DAB) no later than the 
15th day after the notice of exclusion is received by a practitioner or 
other person. The

[[Page 1171]]

date of receipt of the notice of exclusion by the practitioner or other 
person is presumed to be 5 days after the date appearing on the notice, 
unless there is a reasonable showing to the contrary.
    (ii) A request for a preliminary hearing will stay the effective 
date of the exclusion pending a decision of the ALJ at the preliminary 
hearing, and all the parties informed by the OIG of the exclusion will 
be notified of the stay.
    (iii) A request for a preliminary hearing received after the 15-day 
period has expired will be treated as a request for a hearing before an 
ALJ in accordance with paragraph (b) of this section.
    (iv) If the practitioner or other person exercises his, her or its 
right to a preliminary hearing, such a hearing must be held by the ALJ 
in accordance with paragraph (a)(3)(i) of this section unless the OIG 
waives it in accordance with paragraph (a)(6)(i) of this section.
    (v) The ALJ cannot consolidate the preliminary hearing with a full 
hearing without the approval of all parties to the hearing.
    (3)(i) The preliminary hearing will be conducted by an ALJ of the 
DAB in a city that the ALJ deems equitable to all parties. The ALJ will 
conduct the preliminary hearing and render a decision no later than 45 
days after receipt of the request for such a hearing by the DAB. Unless 
there is a reasonable showing to the contrary, date of receipt by the 
DAB is presumed to be 5 days after the date on the request for a 
preliminary hearing or, if undated, the date of receipt will be the date 
the DAB actually received the request. A reasonable extension to the 45-
day period of up to 15 days may be requested by any party to the 
preliminary hearing and such a request may be granted upon concurrence 
by all parties to the preliminary hearing. Such request must be received 
no later than 15 days prior to the scheduled date of the preliminary 
hearing.
    (ii) The only issue to be heard and decided on by the ALJ at the 
preliminary hearing, based on the preponderance of the evidence, is 
whether the practitioner's or other person's continued participation in 
the Medicare and State health care programs during the appeal of the 
exclusion before an ALJ would place program beneficiaries at serious 
risk. The ALJ's decision is to be based on the preponderance of the 
evidence.
    (iii) In the interest of time, the ALJ may issue an oral decision to 
be followed by a written decision.
    (iv) In those cases where the ALJ has stayed an exclusion after a 
preliminary hearing, a full hearing must be held and a decision rendered 
by the ALJ within 6 months. If, for any reason, the request for a full 
hearing before the ALJ is withdrawn or dismissed, the practitioner or 
other person will be excluded effective 5 days after the notice of the 
withdrawal or dismissal is received in the OIG headquarters.
    (4) The preliminary hearing decision is not appealable or subject to 
further administrative or judicial review.
    (5) A practitioner or other person found at the preliminary hearing 
not to place program beneficiaries at serious risk, but later determined 
to have been properly excluded from program participation after a full 
hearing before an ALJ, is not entitled to have the exclusion stayed 
further during an appeal to the DAB. Exclusions in such instances will 
be effective 5 days after receipt of the ALJ decision in the OIG 
headquarters.
    (6)(i) After notice of a timely request for a preliminary hearing, 
the OIG may determine that the practitioner's or other person's 
continued program participation during the appeal before the ALJ will 
not place program beneficiaries at serious risk and waive the 
preliminary hearing. Under these circumstances, the exclusion will be 
stayed pending the decision of the ALJ after a full hearing. the hearing 
must be held, and a decision reached, within 6 months.
    (ii) If the OIG decides to waive the preliminary hearing, the 
request for the preliminary hearing will be considered a request for a 
hearing before the ALJ in accordance with paragraph (b) of this section.
    (b) Right to administrative review. (1) A practitioner or other 
person dissatisfied with an OIG determination, or an exclusion that 
results from a determination not being made within 120

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days, is entitled to appeal such sanction in accordance with part 1005 
of this chapter.
    (2) Due to the 120-day statutory requirement specified in 
Sec. 1004.100(e), the following limitations apply--
    (i) The period of time for submitting additional information will 
not be extended.
    (ii) Any material received by the OIG after the 30-day period 
allowed will not be considered by the ALJ or the DAB.
    (3) The OIG's determination continues in effect unless reversed by a 
hearing.
    (c) Rights to judicial review. Any practitioner or other person 
dissatisfied with a final decision of the Secretary may file a civil 
action in accordance with the provisions of section 205(g) of the Act.