Guidelines –- Appellate Review of Decisions of Administrative Law Judges Relating to Imposition of Civil Money Penalties Based on Violations of the Confidentiality Provisions of the Patient Safety and Quality Improvement Act
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The Code of Federal Regulations (C.F.R.) Title 42, Part 3, Subpart D, authorizes the Secretary to impose civil money penalties on covered entities that violate the confidentiality provisions of Title IX of the Public Health Service Act, as amended by the Patient Safety and Quality Improvement Act of 2005, Public Law No. 109-41. An entity that has received from the Secretary a notice of proposed determination of the intent to impose a civil money penalty may request a hearing before an Administrative Law Judge (ALJ) under the procedures at 42 C.F.R. Part 3, Subpart D. See 42 C.F.R. § 3.504. A dissatisfied party may request review of the ALJ decision by the Departmental Appeals Board (Board). See 42 C.F.R. § 3.548. These guidelines have been designed to assist the parties in understanding and following the procedures in 42 C.F.R. § 3.548 and in other provisions of Subpart D 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. § 3.548, any party dissatisfied with the ALJ decision may appeal that decision to the Board by filing a notice of appeal with the Board. There is no right to appeal to the Board an interlocutory ruling by the ALJ. 42 C.F.R. § 3.548(d).
(b) A covered entity has a right to be represented before the Board, at the entity’s own expense, by an attorney. A representative should file with the Board a signed statement that he or she has been authorized to represent the entity, unless the same representative appeared in the proceedings before the ALJ.
(c) Your notice of appeal must be filed within 30 days of the date of service of the ALJ decision unless you file a written request for an extension which the Board grants for good cause shown. Your request for an extension must be filed within the initial 30-day period and should explain why there is good cause for the requested extension, which may not exceed 30 days. If the ALJ decision is mailed to you, an additional five days is added to the time permitted for filing the notice of appeal. See 45 C.F.R. § 3.548(a).
(d) Your notice of appeal must be accompanied by a written brief specifying 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) 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 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 notice of appeal) 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: brief accompanying notice of appeal – 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 notice of appeal 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 notice of appeal may submit a response, which may also raise any relevant issue not addressed in the notice of appeal. The response must be filed within 30 days after the opposing party receives a copy of the notice of appeal.
(c) The party that filed the notice of appeal may request permission from the Board to file a reply brief.
(d) The Board expects any party needing an extension for filing the response (or any additional submissions permitted or 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.
(e) On rare occasions, the Board may grant a request for oral argument if the Board determines that oral argument would facilitate its decision-making. A party wishing to appear before the Board to present oral argument should request such an opportunity in the notice of appeal or the response and should state the purpose of the requested appearance. Generally, any oral proceeding will be conducted by the Presiding Board Member by telephone conference rather than in person.
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 may not consider issues not raised in the parties’ briefs, nor issues which could have been presented to the ALJ but were not. See 42 C.F.R. § 3.548(3).
(b) If the party demonstrates to the satisfaction of the Board that evidence not presented to the ALJ is relevant and material and that there were reasonable grounds for the failure to present the evidence to the ALJ, the Board may remand the case to the ALJ for consideration of such additional evidence.
(c) The standard of review on a disputed issue of fact is whether the ALJ decision is supported by substantial evidence on the whole record. The standard of review on a disputed issue of law is whether the ALJ decision is erroneous.
(d) The Board may decline to review the case, or may affirm, increase, reduce, reverse or remand any penalty determined by the ALJ.
(e) The Board will serve a copy of its decision on each party within 60 days after the time for the last submission permitted by the Board has expired.
(f) The decision of the Board (other than a remand by the Board to the ALJ) becomes the final decision of the Secretary 60 days after the date of service of the Board’s decision unless a party files a motion for reconsideration in accordance with 42 C.F.R. § 3.548(j).
(g) An affected entity must file any petition for judicial review in accordance with 42 C.F.R. § 3.548(k).
Last Revised: November 12, 2010