The Clinical Laboratory Improvement Amendments of 1988 (CLIA), Title 42 of the United States Code (U.S.C.) § 263a (amending section 353 of the Public Health Service Act), authorize 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 An owner or operator of a laboratory whose CLIA certificate has been revoked, suspended, or limited on one of the bases specified in 42 U.S.C. § 263a(1)(i) is also entitled to an ALJ hearing.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 the Appellate Division at (202) 565-0208 or call the Appellate Division Director directly at the number listed under Contact DAB on the DAB website (https://www.hhs.gov/about/agencies/dab/about-dab/contact-dab/index.html#appellate).
Filing Documents with The Board; Serving Documents
A party may file any document with the Board – including a request for review, a brief, or a request for an extension of time – using either of two methods:
- by sending the document, by postal or commercial delivery service (or, in limited circumstances, by fax), to the Board at its Washington, D.C. address; or
- by submitting the document electronically using the Board’s electronic filing system, called “DAB E-File.”
For general instructions on how to access and use DAB E-File, please review the Board’s E-Filing Instructions.
Rules and requirements for each filing method, as well as the rules for serving a document on a party, are outlined below.
Filing and Service by Postal or Commercial Delivery (or by Fax in Certain Circumstances)
(a) A non-electronic 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) All non-electronic 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.
(c) When filing a document by non-electronic means, send the original and two copies of the document to the Board and a copy to the other party. (If your submission is faxed, the required two copies should be mailed.) Include with any submission to the Board a statement that you have sent a copy to the opposing party.
Electronic Filing and Service Using DAB E-File
(a) Any document, including a request for review, will be deemed to have been filed with the Board on a given day if it is uploaded to DAB E-File on or before 11:59 p.m. eastern time of that day.
(b) If the non-federal party files a request for review electronically via DAB E-file, then both parties should make all future submissions by that method and will be deemed to have consented to accept electronic service of appeal-related documents via DAB E-File (including documents from the Board).
(c) Even when the non-federal party has elected to file a request for review by postal or commercial delivery service, CMS may file its response brief and other appeal-related documents electronically via DAB E-file but should also serve paper copies of its filings upon the non-federal party on or before the applicable filing due dates. In that situation, the Board will issue documents to the non-federal party by postal or commercial delivery service and to CMS via DAB E-file.
(d) CMS may file a request for review electronically via DAB E-file. If it does so, CMS must also send a copy of the request for review to the non-federal party by postal or commercial delivery service. If the non-federal party files its response to CMS’s request for review via DAB E-file, then both parties should make all future filings by that method and will be deemed to have consented to electronic service via DAB E-file.
(e) Sending a document to the Board as an e-mail attachment (or in the body of an e-mail) is not a permitted method of electronic filing. Electronic filing in Board cases must be done using DAB E-file.
Additional Rules Applicable to Both Electronic and Non-Electronic Filing
(a) 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.
(b) 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 or will be available to the Board via DAB E-file, as appropriate.
(c) A submission (including the request for review) may not incorporate by reference a brief or parts of a brief previously submitted to the ALJ.
(d) Certain written submissions are subject to page limits, unless the Board grants a motion to increase the number of pages: brief accompanying 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 with at least one-inch margins and the font size should be no less than 12. Cover letters and attachments are not included in the page count.
Starting the Review Process
(b) Representative. 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) Filing the appeal. A party wishing to appeal the ALJ decision or dismissal must file a request for review within 60 days after receiving the ALJ decision or dismissal unless that party files a written request for an extension which the Board grants for good cause shown. If the ALJ decision or dismissal is mailed to the parties, i.e., sent by postal or commercial delivery service, then the Board will presume that a party received the ALJ decision or dismissal five days after the date on the notice of decision or dismissal unless the party shows that it was received later or the other party shows that it was received earlier. See 42 C.F.R. §§ 498.82(a)(2), 498.22(b)(3). If a party consented to accept service of documents via DAB E-file during the proceeding before the ALJ, then the date of service of the ALJ decision or dismissal will be deemed to be the date it is uploaded to DAB E-file.
(d) Contents of request for review. 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 or dismissal 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.
(e) Docketing and acknowledgment of request for review. After receiving a request for review, the Board will assign a docket number to the appeal and send the parties (by postal or commercial delivery service or electronically via DAB E-file, as appropriate) a letter that acknowledges receipt of the appeal, describes the remaining steps of the appeal process and how the record on appeal will be developed, and provides information about how to contact the Board with questions about Board procedures or case status.
Development of the Record on Appeal
(a) After the request for review is docketed, it 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 filed the appeal must submit a response. The response must be filed within 30 days after receipt (by postal or commercial delivery service or electronically via DAB E-file) of a copy of the request for review.
(c) The party that filed the request for review then may submit a reply. The reply must be filed within 15 days after receipt (by postal or commercial delivery service or electronically via DAB E-file) of a copy of the response.
(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 for filing the response or the reply (or any additional submissions required by the Board) to file a request for an 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. A party wishing to appear before the Board to present oral argument should request such an opportunity no later than the time for filing its last submission provided for in paragraph (b) or (c) of this section and should state the purpose of the requested appearance. Generally, any oral proceeding will be conducted by the Presiding Board Member by telephone conference.
(g) While the Board may admit additional evidence into the record (during oral proceedings or through written submission) after notice to the parties, the Board will do so only 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 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.
(b) 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.
(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 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.
(d) The Board’s decision or dismissal order 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)).
For purposes of determining when a civil action seeking judicial review must be filed, the date of receipt of the Board’s decision or dismissal order will be deemed to be the date it is uploaded to DAB E-file if the laboratory, prospective laboratory, or laboratory owner or operator consented to receiving appeal related-documents via DAB E-file.