Guidelines -- Appellate Review of Decisions of Administrative Law Judges in Cases Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and Related Statutes
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The Public Health Service Act at Section 353 of Title 42 of the United States Code (U.S.C.) § 263a, as amended by the Clinical Laboratory Improvement Amendments of 1988 (CLIA), authorizes the Secretary to impose sanctions on laboratories, and to deny CLIA certificates to prospective laboratories, that are found not to meet federal requirements. Regulations promulgated by the Centers for Medicare & Medicaid Services (CMS) at Part 493, Subpart R of Title 42 of the Code of Federal Regulations (C.F.R.) describe the Department's enforcement procedures leading to sanctions and provide that any laboratory or prospective 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. An owner or operator of a laboratory whose CLIA certificate has been revoked, suspended, or limited on one of the bases specified in 42 U.S.C. § 263a(1)(i) is also entitled to an ALJ hearing. The regulations at Subpart R of Part 493 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), any 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 you show that it was received later or the other party shows that it was received earlier.
(b) A laboratory, prospective laboratory, or laboratory owner or operator has a right to be represented before the Board, at its own expense, by an attorney or someone else. A representative should file with the Board a signed statement that he or she has been authorized to represent the laboratory, prospective laboratory, or laboratory owner or operator, unless the same representative appeared in the proceedings before the ALJ.
(c) Your request for review must specify each finding of fact and conclusion of law with which you disagree, and your basis for contending that each such finding or conclusion is unsupported or incorrect. The Board expects that the basis for each challenge to a finding or conclusion in the ALJ decision will be set forth in a separate paragraph or section, and that the accompanying arguments will be 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" with the Board 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 (where permitted) 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
330 Independence Ave., S.W.
Cohen Building, Room G-644
Washington, D.C. 20201
Faxes should be sent to (202) 565-0238. Please do not fax a submission if it is over 10 pages.
(d) The parties should provide an original and two copies of all submissions to the Board and a copy to the opposing party or parties. (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 or parties.
(e) The parties should not submit to the Board materials already submitted to the ALJ since those materials will be transferred to the Board by the ALJ.
(f) A submission (including the request for review) may not incorporate by reference a brief or parts of a brief previously submitted to the ALJ.
(g) Certain written submissions are subject to page limits, unless the Board grants a motion to increase the number of pages: request for review - no more than 40 pages; response - no more than 40 pages; reply - no more than 20 pages. If typed, the submission should be double-spaced and the font size should be no less than 12. Cover letters and attachments are not included in the page count.
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 or parties that requested review must 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 or parties that requested review then may submit a reply. The reply must be filed within 15 days after receipt of a copy of the opposing party's submission in (b) above.
(d) If both CMS and another party or 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 a 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 submission provided for in (b) or (c) above 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, prospective laboratory's, or laboratory owner's or operator's request for review unless the Board dismisses the request because: (1) the laboratory, prospective laboratory, or laboratory owner or operator requests dismissal; (2) the laboratory, prospective laboratory, or laboratory owner or operator did not file timely (or show good cause for late filing); (3) the laboratory, prospective laboratory, or laboratory owner or operator 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) 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 as a whole. 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.
(c) 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 need not consider issues not raised in the request for review, nor issues which could have been presented to the ALJ but were not.
(d) The decision of the Board (other than a remand by the Board to the ALJ) is binding unless:
- the laboratory, prospective laboratory, or laboratory owner or operator 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)).
Last Revised: December 1, 2008