Departmental Appeals Board
GUIDELINES --
APPELLATE REVIEW OF DECISIONS OF
ADMINISTRATIVE LAW JUDGES IN CASES UNDER THE CLINICAL LABORATORY IMPROVEMENT
AMENDMENTS OF 1988 (CLIA) AND RELATED STATUTES
Introduction
Statutes including
the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Public
Law 100-578, authorize the Secretary to impose sanctions on laboratories
that are found not to meet federal requirements. Regulations promulgated
by the Centers for Medicare & Medicaid Services (CMS) at subpart R
of 42 C.F.R. Part 493 describe the Department's enforcement procedures
leading to sanctions and provide that any laboratory dissatisfied with
an initial determination by CMS may receive a hearing by an administrative
law judge (ALJ) in accordance with subpart D of 42 C.F.R. Part 498. The
regulations at subpart R of Part 493 also entitle a dissatisfied party
to request review of the ALJ decision by the Departmental Appeals Board
(Board) in accordance with the procedures in subpart E of Part 498. These
guidelines have been designed to assist the parties in understanding and
following the procedures relating to Board review.
If you have any questions
about these guidelines, you may call Appellate Division attorney Carolyn
Reines-Graubard at (202) 565-0116.
Starting the Review Process
(a) Under 42 C.F.R.
§ 493.1844(a)(3), either party dissatisfied with an ALJ decision or a
dismissal is entitled to request review as specified in subpart E of 42
C.F.R. Part 498. Your request for review must
be filed within 60 days after you receive the ALJ decision or dismissal
unless you make a written request for an
extension which the Board grants for good cause shown. The Board
will presume that you received the ALJ decision or dismissal five days
after the date on the notice of decision or dismissal unless there is
a showing that it was received earlier or later.
(b) Your request for
review must specify the findings of fact and conclusions of law with which
you disagree, and your basis for contending that each such finding or
conclusion is unsupported or incorrect. You should not merely incorporate
by reference a brief previously submitted to the ALJ. Instead, the Board
expects that the basis for challenging each element of the ALJ decision
will be set forth in a separate paragraph or section, and the accompanying
arguments concisely stated. In addition, where appropriate, each argument
should be supported by precise citations to the record and/or by precise
citations to statutes, regulations or other relevant authorities upon
which you are relying.
Filing Requirements for All Submissions
(a)
A submission is considered "filed" on the postmark date, the date
sent by registered or certified mail, the date deposited with a commercial
delivery service, or the date a fax is sent.
(b) If the last day of the period for filing a submission falls on a federal nonworkday (a Saturday, Sunday, legal holiday, or a day which by statute or Executive Order is declared to be a nonworkday for federal employees), the submission may be filed on the next federal workday.
(c) All submissions
to the Board should be addressed to: Department of Health and Human Services,
Departmental Appeals Board, MS 6127, Appellate Division, 330 Independence
Ave., S.W., Cohen Building, Room G-644, Washington, D.C. 20201. Faxes
should be sent to (202) 565-0238. Do not fax a submission if it
is over 10 pages.
(d) Both parties should
provide an original and two copies of all submissions to the Board and
a copy to the opposing party. (If your submission
is faxed, the required two copies should be mailed.) Include in
any submission to the Board a statement that you have sent a copy to the
opposing party.
(e) The parties should
not submit materials already in the record to
the Board since those materials will be transferred to the Board by the
ALJ.
Development of the Record on Appeal
(a) The request for
review is referred to a panel of three Board members, one of whom presides
over the development of the record on appeal. The Presiding Board Member
is assisted by a staff attorney whom the parties may contact if they have
questions about case status or procedures.
(b) The opponent of
the party that requested review may submit a response. The response must
be filed within 30 days after
the opposing party receives a copy of the request for review.
(c) The party that
requested review then may submit a reply. The reply must be filed within
15 days after receipt of the opposing party's submission in (b) above.
(d) If both parties
have filed a request for review, the Board may provide for the parties'
responses and replies to be filed simultaneously.
(e) The Board expects
any party needing an extension to file the response or the reply (or any
additional submissions required by the Board) to file a request for extension
before the original due date, to include a statement about whether the
opposing party objects to the requested extension, and to state the reasons
for the request. The Board will grant an extension only for good cause
shown.
(f) Generally, the
request for review, the response and the reply are the only record additions
on appeal. If either party wishes to appear before the Board to present
evidence or oral argument, that party should request such an opportunity
no later than the time for filing its last required submission and should
state the purpose of the requested appearance. A party seeking to present
testimonial evidence in such a proceeding should address the criteria
noted in (g) below. Generally, any oral proceeding will be conducted by
the Presiding Board Member by telephone conference rather than in person.
(g) While the Board
may admit evidence into the record (during oral proceedings or through
written submission) after notice to the parties, the Board will only do
so if it considers the additional evidence to be relevant and material
to an issue before it. In deciding whether to admit evidence, the Board
will also consider whether the party that proffers the evidence has demonstrated
good cause for not producing the evidence during proceedings before the
ALJ. The Board may require a party to produce relevant evidence or information
at any point in the process.
Completion of the Review Process
(a) The Board may
dismiss, deny, or grant CMS's request for review. The Board will grant
the laboratory's request for review unless the Board dismisses the request
because: (1) the laboratory requests dismissal; (2) the laboratory did
not file timely (or show good cause for late filing); (3) the laboratory
does not have a right to review; or (4) a previous determination or decision
on the same facts and law and regarding the same question has become final
as specified in 42 C.F.R. §
498.83(b)(4). The Board also may remand any case to the ALJ, with appropriate
instructions.
(b) Generally, the
Board will complete its review and issue a determination within 30 days
after it receives the last submission from the parties.
(c) The Board has
adopted the following standard of review. The standard of review on a
disputed factual issue is whether the ALJ decision is supported by substantial
evidence in the record. The standard of review on a disputed issue of
law is whether the ALJ decision is erroneous. The bases for modifying,
reversing or remanding an ALJ decision include the following: a finding
of material fact necessary to the outcome of the decision is not supported
by substantial evidence; a legal conclusion necessary to the outcome of
the decision is erroneous; the decision is contrary to law or applicable
regulations; a prejudicial error of procedure (including an abuse of discretion
under the law or applicable regulations) was committed.
(d) The Board will
review only those parts of the record before the ALJ which are cited by
the parties or which the Board considers necessary to decide the appeal.
The Board will not consider issues not raised in the request for review,
nor issues which could have been presented to the ALJ but were not.
(e) The decision of
the Board (other than a remand by the Board to the ALJ) is binding unless:
- the laboratory
has a right to judicial review and timely files a civil action seeking
judicial review in accordance with 42 C.F.R. § 493.1844(f)(3), or
- the Board reopens
and revises its decision in accordance with 42 C.F.R. § 498.102 (incorporated
by reference in section 498.90(a)(2)).
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