45 C.F.R. PART 13—IMPLEMENTATION OF THE EQUAL ACCESS TO JUSTICE ACT IN AGENCY PROCEEDINGS
Title 45 - Public Welfare
Authority: 5 U.S.C. 504(c)(1).
Source: 48 FR 45252, Oct. 4, 1983, unless otherwise noted.
These rules implement section 203 of the Equal Access to Justice Act, 5 U.S.C. 504 and 504 note, for the Department of Health and Human Services. They describe the circumstances under which the Department may award attorney fees and certain other expenses to eligible individuals and entities who prevail over the Department in certain administrative proceedings (called “adversary adjudications”). The Department may reimburse parties for expenses incurred in adversary adjudications if the party prevails in the proceeding and if the Department's position in the proceeding was not substantially justified or if the action is one to enforce compliance with a statutory or regulatory requirement and the Department's demand is substantially in excess of the ultimate decision and is unreasonable when compared with that decision. They also describe what proceedings constitute adversary adjudications covered by the Act, what types of persons and entities may be eligible for an award, and what procedures and standards the Department will use to make a determination as to whether a party may receive an award. [48 FR 45252, Oct. 4, 1983, as amended at 69 FR 2845, Jan. 21, 2004] These rules apply to adversary adjudications before the Department. [69 FR 2845, Jan. 21, 2004] (a) These rules apply only to adversary adjudications. For the purpose of these rules, only an adjudication required to be under 5 U.S.C. 554, in which the position of the Department or one of its components is represented by an attorney or other representative (“the agency's litigating party”) who enters an appearance and participates in the proceeding, constitutes an adversary adjudication. These rules do not apply to proceedings for the purpose of establishing or fixing a rate or for the purpose of granting, denying, or renewing a license. (b) If the agency's litigating party enters an appearance, Department proceedings listed in Appendix A to this part are covered by these rules. Also covered are any other proceedings under statutes that incorporate by reference the procedures of sections 1128(f), 1128A(c)(2), or 1842(j)(2) of the Social Security Act, 42 U.S.C. 1320a–7(f), 1320a–7a(c)(2), or 1395u(j)(2). If a proceeding is not covered under either of the two previous sentences, a party may file a fee application as otherwise required by this part and may argue that the Act covers the proceeding. Any coverage issue shall be determined by the adjudicative officer and, if necessary, by the appellate authority on review. (c) If a proceeding is covered by these rules, but also involves issues excluded under paragraph (a) of this section from the coverage of these rules, reimbursement is available only for fees and expenses resulting from covered issues. [45 FR 45252, Oct. 4, 1983, as amended at 69 FR 2845, Jan. 21, 2004] (a) To be eligible for an award of attorney fees and other expenses under these regulations, the applicant must be a party, as defined in 5 U.S.C. 551(3), to the adversary adjudication for which it seeks an award. An applicant must show that it meets all conditions of eligibility set out in this subpart and in Subpart B. (b) The categories of eligible applicants are as follows: (1) Charitable or other tax-exempt organizations described in section 501(c)(3) of the Internal Revenue Code (26 U.S.C. 501(c)(3)) with not more than 500 employees; (2) Cooperative associations as defined in section 15(a) of the Agricultural Marketing Act (12 U.S.C. 1141j(a)) with not more than 500 employees; (3) Individuals with a net worth of not more than $2 million; (4) Sole owners of unincorporated businesses if the owner has a net worth of not more than $7 million, including both personal and business interests, and if the business has not more than 500 employees; (5) All other partnerships, corporations, associations, local governmental units, and public and private organizations with a net worth of not more than $7 million and with not more than 500 employees; and (6) Where an award is sought on the basis stated in §13.5(c) of this part, small entities as defined in 5 U.S.C. 601. (c) For the purpose of determining eligibility, the net worth and number of employees of an applicant is calculated as of the date the proceeding was initiated. The net worth of an applicant is determined by generally accepted accounting principles. (d) Whether an applicant who owns an unincorporated business will be considered as an “individual” or a “sole owner of an unincorporated business” will be determined by whether the applicant's participation in the proceeding is related primarily to individual interests or to business interests. (e) The employees of an applicant include all those persons regularly providing services for remuneration for the applicant, under the applicant's direction and control. Part-time employees shall be included on a proportional basis. (f) The net worth and number of employees of the applicant and all of its affiliates shall be aggregated to determine eligibility. Any individual, corporation or other entity that directly or indirectly controls or owns a majority of the voting shares or other interest of the applicant, or any corporation or other entity of which the applicant directly or indirectly owns or controls a majority of the voting shares or other interest, will be considered an affiliate for purposes of this part, unless the adjudicative officer determines that such treatment would be unjust and contrary to the purposes of the Act in light of the actual relationship between the affiliated entities. In addition, the adjudicative officer may determine that financial relationships of the applicant other than those described in this paragraph constitute special circumstances that would make an award unjust. (g) An applicant is not eligible if it appears from the facts and circumstances that it has participated in the proceedings only or primarily on behalf of other persons or entities that are ineligible. [48 FR 45252, Oct. 4, 1983, as amended at 69 FR 2846, Jan. 21, 2004] (a) An award of fees and expenses may be made either on the basis that the Department's position in the proceeding was not substantially justified or on the basis that, in a proceeding to enforce compliance with a statutory or regulatory requirement, the Department's demand substantially exceeded the ultimate decision and was unreasonable when compared with that decision. These two bases are explained in greater detail in paragraphs (b) and (c) of this section. (b) Awards where the Department's position was not substantially justified. (1) Awards will be made on this basis only where the Department's position in the proceeding was not substantially justified. The Department's position includes, in addition to the position taken by the agency in the proceeding, the agency action or failure to act that was the basis for the proceeding. Whether the Department's position was substantially justified is to be determined on the basis of the administrative record as a whole. The fact that a party has prevailed in a proceeding does not create a presumption that the Department's position was not substantially justified. The burden of proof as to substantial justification is on the agency's litigating party, which may avoid an award by showing that its position was reasonable in law and fact. (2) When two or more matters are joined together for one hearing, each of which could have been heard separately (without regard to laws or rules fixing a jurisdictional minimum amount for claims), and an applicant has prevailed with respect to one or several of the matters, an eligible applicant may receive an award for expenses associated only with the matters on which it prevailed if the Department's position on those matters was not substantially justified. (3) Awards for fees and expenses incurred before the date on which a proceeding was initiated will be made only if the applicant can demonstrate that they were reasonably incurred in preparation for the proceeding. (4) Awards will be reduced or denied if the applicant has unduly or unreasonably protracted the proceeding or if other special circumstances make an award unjust. (c) Awards where the Department's demand was substantially excessive and unreasonable. (1) Awards will be made on this basis only where the adversary adjudication arises from the Department's action to enforce a party's compliance with a statutory or regulatory requirement. An award may be made on this basis only if the Department's demand that led to the proceeding was substantially in excess of the ultimate decision in the proceeding, and that demand is unreasonable when compared with that decision, given all the facts and circumstances of the case. (2) Any award made on this basis shall be limited to the fees and expenses that are primarily related to defending against the excessive nature of the demand. An award shall not include fees and expenses that are primarily related to defending against the merits of charges, or fees and expenses that are primarily related to defending against the portion of the demand that was not excessive, to the extent that these fees and expenses are distinguishable from the fees and expenses primarily related to defending against the excessive nature of the demand. (3) Awards will be denied if the party has committed a willful violation of law or otherwise acted in bad faith, or if special circumstances make an award unjust. [48 FR 45252, Oct. 4, 1983, as amended at 69 FR 2846, Jan. 21, 2004] (a) Awards will be limited to the rates customarily charged by persons engaged in the business of acting as attorneys, agents and expert witnesses. If a party has already received, or is eligible to receive, reimbursement for any expenses under another statutory provision or another program allowing reimbursement, its award under these rules must be reduced by the amount the prevailing party has already received, or is eligible to receive, from the Federal government. (b) An award for the fees of an attorney or agent may not exceed $125.00 per hour, regardless of the actual rate charged by the attorney or agent. An award for the fees of an expert witness may not exceed the highest rate at which the Department pays expert witnesses, which is $24.09 per hour, regardless of the actual rates charged by the witness. These limits apply only to fees; an award may include the reasonable expenses of the attorney, agent, or witness as a separate item, if the attorney, agent or witness ordinarily charges separately for such expenses. (c) In determining the reasonableness of the fees sought for attorneys, agents or expert witnesses, the adjudicative officer must consider factors bearing on the request, which include, but are not limited to: (1) If the attorney, agent or witness is in private practice, his or her customary fee for like services; if the attorney, agent or witness is an employee of the applicant, the fully allocated cost of service; (2) The prevailing rate for similar services in the community in which the attorney, agent or witness ordinarily performs services; (3) The time actually spent in the representation of the applicant; (4) The time reasonably spent in light of the difficulty or complexity of the issues in the proceeding; and (5) Such other factors as may bear on the value of the services provided. [48 FR 45252, Oct. 4, 1983, as amended at 69 FR 2846, Jan. 21, 2004] The reasonable cost (or the reasonable portion of the cost) for any study, exhibit, analysis, engineering report, test, project or similar matter prepared on behalf of a party may be awarded to the extent that: (a) The charge for the service does not exceed the prevailing rate payable for similar services, (b) The study or other matter was necessary to the preparation for the administrative proceeding, and (c) The study or other matter was prepared for use in connection with the administrative proceeding. No award will be made for a study or other matter which was necessary to satisfy statutory or regulatory requirements, or which would ordinarily be conducted as part of the party's business irrespective of the administrative proceeding. (a) Applications for an award of fees and expenses must include: (1) The name of the applicant and the identification of the proceeding; (2) Where an award is sought on the basis stated in §13.5(b) of this part, a declaration that the applicant believes it has prevailed, and an identification of the position of the Department that the applicant alleges was not substantially justified. Where an award is sought on the basis stated in §13.5(c) of this part, an identification of the statutory or regulatory requirement that the applicant alleges the Department was seeking to enforce, and an identification of the Department's demand and of the document or documents containing that demand; (3) Unless the applicant is an individual, a statement of the number of its employees on the date on which the proceeding was initiated, and a brief description of the type and purpose of its organization or business. However, where an award is sought solely on the basis stated in §13.5(c) of this part, the applicant need not state the number of its employees; (4) A description of any affiliated individuals or entities, as the term “affiliate” is defined in §13.4(f), or a statement that none exist; (5) A statement that the applicant's net worth as of the date on which the proceeding was initiated did not exceed the appropriate limits as stated in §13.4(b) of this part. However, an applicant may omit this statement if: (i) It attaches a copy of a ruling by the Internal Revenue Service that it qualifies as an organization described in section 501(c)(3) of the Internal Revenue Code (26 U.S.C. 501(c)(3)) or, in the case of a tax-exempt organization not required to obtain a ruling from the Internal Revenue Service on its exempt status, a statement that describes the basis for the applicant's belief that it qualified under such section; (ii) It states that it is a cooperative association as defined in section 15(a) of the Agricultural Marketing Act (12 U.S.C. 1141j(a)); or (iii) It states that it is applying for an award solely on the basis stated in §13.5(c) of this part, and that it is a small entity as defined in 5 U.S.C. 601, and it describes the basis for its belief that it qualifies as a small entity under that section. (6) A statement of the amount of fees and expenses for which an award is sought; (7) A declaration that the applicant has not received, has not applied for, and does not intend to apply for reimbursement of the cost of items listed in the Statement of Fees and Expenses under any other program or statute; or if the applicant has received or applied for or will receive or apply for reimbursement of those expenses under another program or statute, a statement of the amount of reimbursement received or applied for or intended to be applied for; and (8) Any other matters the applicant wishes the Department to consider in determining whether and in what amount an award should be made. (b) All applications must be signed by the applicant or by an authorized officer or attorney of the applicant. It shall also contain or be accompanied by a written verification under oath or under penalty of perjury that the information provided in the application is true and correct. [48 FR 45252, Oct. 4, 1983, as amended at 69 FR 2846, Jan. 21, 2004] (a) Each applicant must provide with its application a detailed exhibit showing the net worth of the applicant and any affiliates (as defined in §13.4(f) of this part) when the proceeding was initiated. This requirement does not apply to a qualified tax-exempt organization or cooperative association. Nor does it apply to a party that states that it is applying for an award solely on the basis stated in §13.5(c) of this part. If any individual, corporation, or other entity directly or indirectly controls or owns a majority of the voting shares or other interest of the applicant, or if the applicant directly or indirectly owns or controls a majority of the voting shares or other interest of any corporation or other entity, the exhibit must include a showing of the net worth of all such affiliates or of the applicant including the affiliates. The exhibit may be in any form convenient to the applicant that provides full disclosure of the applicant's and its affiliates' assets and liabilities and is sufficient to determine whether the applicant qualifies under the standards in this part. The adjudicative officer may require an applicant to file additional information to determine its eligibility for an award. (b) The net worth exhibit shall describe any transfers of assets from, or obligations incurred by, the applicant or any affiliate, occurring in the one year period prior to the date on which the proceeding was initiated, that reduced the net worth of the applicant and its affiliates below the applicable net worth ceiling. If there were no such transactions, the applicant shall so state. (c) Ordinarily, the net worth exhibit will be included in the public record of the proceeding. However, an applicant that objects to public disclosure of information in any portion of the exhibit and believes there are legal grounds for withholding it from disclosure may submit that portion of the exhibit directly to the adjudicative officer in a sealed envelope labeled “Confidential Financial Information,” accompanied by a motion to withhold the information from public disclosure. The motion shall describe the information sought to be withheld and explain, in detail, why it falls within one or more of the specific exemptions from mandatory disclosure under the Freedom of Information Act, 5 U.S.C. 552(b)(1)–(9), why public disclosure of the information would adversely affect the applicant, and why disclosure is not required in the public interest. The material in question shall be served on counsel representing the agency against which the applicant seeks an award, but need not be served on any other party to the proceeding. If the adjudicative officer finds that the information should not be withheld from disclosure, it shall be placed in the public record of the proceeding. Otherwise, the officer will omit the material from the public record. In that case, any decision regarding disclosure of the material (whether in response to a request from an agency or person outside the Department or on the Department's own initiative) will be made in accordance with applicable statutes and Department rules and procedures for commercial and financial records which the submitter claims are confidential or privileged. In particular, this regulation is not a basis for a promise or obligation of confidentiality. [48 FR 45252, Oct. 4, 1983, as amended at 69 FR 2846, Jan. 21, 2004] (a) All applicants must be accompanied by full documentation of the fees and expenses, including the cost of any study, exhibit, analysis, report, test or other similar item, for which the applicant seeks reimbursement. (b) The documentation shall include an affidavit from each attorney, agent, or expert witness representing or appearing in behalf of the party, stating the actual time expended, the rate at which fees and other expenses were computed, a description of the specific services performed, the total amount claimed, and the total amount paid or payable by the applicant or by any other person or entity for the services provided. Where the adversary adjudication includes covered proceedings (as described in §13.3) as well as excluded proceedings, or two or more matters, each of which could have been heard separately, the fees and expenses shall be shown separately for each proceeding or matter, and the basis for allocating expenses among the proceedings or matters shall be indicated. (1) The affidavit shall itemize in detail the services performed by the date, number of hours per date and the services performed during those hours. In order to establish the hourly rate, the affidavit shall state the hourly rate which is billed and paid by the majority of clients during the relevant time periods. (2) If no hourly rate is paid by the majority of clients because, for instance, the attorney or agent represents most clients on a contingency basis, the attorney or agent shall provide affidavits from two attorneys or agents with similar experience, who perform similar work, stating the hourly rate which they bill and are paid by the majority of their clients during a comparable time period. (c) If the applicant seeks reimbursement of any expenses not covered by the affidavit described in paragraph (b), the documentation must also include an affidavit describing all such expenses and stating the amounts paid or payable by the applicant or by any other person or entity for the services provided. (d) The adjudicative officer may require the applicant to provide vouchers, receipts, or other substantiation for any fees or expenses claimed, pursuant to §13.25 of this part. [48 FR 45252, Oct. 4, 1983, as amended at 69 FR 2847, Jan. 21, 2004] All pleadings, including applications for an award of fees, answers, comments, and other pleadings related to the applications, shall be filed in the same manner as other pleadings in the proceeding and served on all other parties and participants, except as provided in §13.11(b) of this part concerning confidential financial information. (a) The applicant must file and serve its application no later than 30 calendar days after the Department's final disposition of the proceeding which makes the applicant a prevailing party. (b) For purposes of this rule, final disposition means the date on which a decision or order disposing of the merits of the proceeding or any other complete resolution of the proceeding, such as a settlement or voluntary dismissal, becomes final and unappealable, both within the agency and to the courts. (c) For purposes of this rule, an applicant has prevailed when the agency has made a final disposition favorable to the applicant with respect to any matter which could have been heard as a separate proceeding, regardless of whether it was joined with other matters for hearing. (d) If review or reconsideration is sought or taken, whether within the agency or to the courts, of a decision as to which an applicant believes it has prevailed, proceedings on the application shall be stayed pending final disposition of the underlying controversy. [48 FR 45252, Oct. 4, 1983, as amended at 69 FR 2847, Jan. 21, 2004] (a) The agency's litigating party shall file an answer within 30 calendar days after service of the application or, where the proceeding is stayed as provided in §13.22(d) of this part, within 30 calendar days after the final disposition of the underlying controversy. The answer shall either consent to the award or explain in detail any objections to the award requested and identify the facts relied on in support of the agency's position. The adjudicative officer may for good cause grant an extension of time for filing an answer. (b) Within 15 calendar days after service of an answer, the applicant may file a reply. If the reply is based on any alleged facts not already in the record of the proceeding, the applicant shall include with the reply either supporting affidavits or a request for further proceedings under §13.25. (c) Any party to or participant in a proceeding may file comments on an application within 30 calendar days, or on an answer within 15 calendar days after service of the application or answer. [48 FR 45252, Oct. 4, 1983, as amended at 69 FR 2847, Jan. 21, 2004] The applicant and the agency's litigating party may agree on a proposed settlement of the award at any time prior to final action on the application. If the parties agree on a proposed settlement of an award before an application has been filed, the application shall be filed with the proposed settlement. All settlements must be approved by the adjudicative officer and the head of the agency or office or his or her designee before becoming final. (a) Ordinarily, a decision on an application will be made on the basis of the hearing record and pleadings related to the application. However, at the request of either the applicant or the agency's litigating party, or on his or her own initiative, the adjudicative officer may order further proceedings, including an informal conference, oral argument, additional written submissions, or an evidentiary hearing. Such further proceedings shall be held only when necessary for full and fair resolution of the issues arising from the application, and shall be conducted as promptly as possible. In no such further proceeding shall evidence be introduced from outside the administrative record in order to prove that the Department's position was, or was not, substantially justified. (b) A request that the adjudicative officer order additional written submissions or oral testimony shall identify the information sought and shall explain why the information is necessary to decide the issues. (c) The adjudicative officer may impose sanctions on any party for failure to comply with his or her order to file pleadings, produce documents, or present witnesses for oral examination. These sanctions may include but are not limited to granting the application partly or completely, dismissing the application, and diminishing the award granted. [48 FR 45252, Oct. 4, 1983, as amended at 69 FR 2847, Jan. 21, 2004] The adjudicative officer shall issue an initial decision on the application as promptly as possible after the filing of the last document or conclusion of the hearing. The decision must include written findings and conclusions on the applicant's eligibility and status as a prevailing party, including a finding on the net worth of the applicant. Where the adjudicative officer has determined under §13.11(b) that the applicant's net worth information is exempted from disclosure under the Freedom of Information Act, the finding on net worth shall be kept confidential. The decision shall also include, if at issue, findings on whether the agency's position was substantially justified, whether the applicant unduly protracted the proceedings, an explanation of any difference between the amount requested and the amount awarded, and whether any special circumstances make the award unjust. (a) The appellate authority for any proceedings shall be the official or component that would have jurisdiction over an appeal of the merits. (b) If either the applicant or the agency's litigating party seeks review of the adjudicative officer's decision on the fee application, it shall file and serve exceptions within 30 days after issuance of the initial decision. Within another 30 days after receipt of such exceptions, the opposing party, if it has not done so previously, may file its own exceptions to the adjudicative officer's decision. The appellate authority shall issue a final decision on the application as soon as possible or remand the application to the adjudicative officer for further proceedings. Any party that does not file and serve exceptions within the stated time limit loses the opportunity to do so. [69 FR 2847, Jan. 21, 2004] Judicial review of final agency decisions on awards may be obtained as provided in 5 U.S.C. 504(c)(2). The notification to an applicant of a final decision that an award will be made shall contain the name and address of the appropriate Departmental finance office that will pay the award. An applicant seeking payment of an award shall submit to that finance officer a copy of the final decision granting the award, accompanied by a statement that the applicant will not seek review of the decision in the United States courts. The Department will pay the amount awarded to the applicant within 60 days, unless judicial review of the award or of the underlying decision of the adversary adjudication has been sought by the applicant or any other party to the proceedings. Upon the filing of an application pursuant to §13.11(a), the officer who presided over the taking of evidence in the proceeding which gave rise to the application will, if available, be automatically designated as the adjudicative officer for the handling of the application. [69 FR 2847, Jan. 21, 2004]
Title 45: Public Welfare
PART 13—IMPLEMENTATION OF THE EQUAL ACCESS TO JUSTICE ACT IN AGENCY PROCEEDINGS
Section Contents
§ 13.1 Purpose of these rules.
§ 13.2 When these rules apply.
§ 13.3 Proceedings covered.
§ 13.4 Eligibility of applicants.
§ 13.5 Standards for awards.
§ 13.6 Allowable fees and expenses.
§ 13.7 Studies, exhibits, analyses, engineering reports, tests and projects.
§ 13.10 Contents of application.
§ 13.11 Net worth exhibits.
§ 13.12 Documentation of fees and expenses.
§ 13.21 Filing and service of pleadings.
§ 13.22 When an application may be filed.
§ 13.23 Responsive pleadings.
§ 13.24 Settlements.
§ 13.25 Further proceedings.
§ 13.26 Decisions.
§ 13.27 Agency review.
§ 13.28 Judicial review.
§ 13.29 Payment of award.
§ 13.30 Designation of adjudicative officer.
Appendix A to Part 13
Subpart A—General Provisions
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§ 13.1 Purpose of these rules.
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§ 13.2 When these rules apply.
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§ 13.3 Proceedings covered.
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§ 13.4 Eligibility of applicants.
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§ 13.5 Standards for awards.
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§ 13.6 Allowable fees and expenses.
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§ 13.7 Studies, exhibits, analyses, engineering reports, tests and projects.
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Subpart B—Information Required from Applicants
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§ 13.10 Contents of application.
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§ 13.11 Net worth exhibits.
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§ 13.12 Documentation of fees and expenses.
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Subpart C—Procedures for Considering Applications
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§ 13.21 Filing and service of pleadings.
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§ 13.22 When an application may be filed.
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§ 13.23 Responsive pleadings.
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§ 13.24 Settlements.
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§ 13.25 Further proceedings.
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§ 13.26 Decisions.
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§ 13.27 Agency review.
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§ 13.28 Judicial review.
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§ 13.29 Payment of award.
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§ 13.30 Designation of adjudicative officer.
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Appendix A to Part 13
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------------------------------------------------------------------------ Applicable Proceedings covered Statutory authority regulations------------------------------------------------------------------------ Office of Inspector General------------------------------------------------------------------------1. Proceedings to impose 42 U.S.C. 1320a- 42 CFR Part 1003; civil monetary penalties, 7a(c)(2); 1320b- 42 CFR Part 1005. assessments, or exclusions 10(c); 1395i- from Medicare and State 3(b)(3)(B)(ii), health care programs. (g)(2)(A)(i); 1395l (h)(5)(D), (i)(6); 1395m(a)(11)(A), (a)(18), (b)(5)(C), (j)(2)(A)(iii); 1395u(j)(2), (k), (l )(3), (m)(3), (n)(3), (p)(3)(A); 1395y(b)(3)(C), (b)(6)(B); 1395cc(g); 1395dd(d)(1)(A), (B); 1395mm(i)(6)(B); 1395nn(g)(3), (4); 1395ss(d); 1395bbb(c)(1); 1396b(m)(5)(B); 1396r(b)(3)(B)(ii), (g)(2)(A)(i); 1396t(i)(3); 11131(c); 11137(b)(2).2. Appeals of exclusions from 42 U.S.C. 1320a-7(f); 42 CFR Part 1001; Medicare and State health 1395l (h)(5)(D); 42 CFR Part 1005. care programs and/or other 1395m(a)(11)(A), programs under the Social (b)(5)(C); Security Act. 1395u(j)(2), (k), (l )(3), (m)(3), (n)(3), (p)(3)(B).3. Appeal of exclusions from 42 U.S.C. 1320c- 42 CFR Part 1004; programs under the Social 5(b)(4), (5). 42 CFR Part 1005. Security Act, for which services may be provided on the recommendation of a Peer Review Organization.4. Proceedings to impose 31 U.S.C. 3803....... 45 CFR Part 79. civil penalties and assessments for false claims and statements.------------------------------------------------------------------------ Centers for Medicare & Medicaid Services------------------------------------------------------------------------1. Proceedings to suspend or 42 U.S.C. 263a(i); 42 CFR Part 493, revoke licenses of clinical 1395w-2. Subpart R. laboratories.2. Proceedings provided to a 42 U.S.C. 1395h(e)(1)- 42 CFR 421.114, fiscal intermediary before (3). 421.128. assigning or reassigning Medicare providers to a different fiscal intermediary.3. Appeals of determinations 42 U.S.C. 1395cc(h); 42 CFR 489.53(d); that an institution or 1395dd(d)(1)(A). 42 CFR Part 498. agency is not a Medicare provider of services, and appeals of terminations or nonrenewals of Medicare provider agreements.4. Proceedings before the 42 U.S.C. 1395oo..... 42 CFR Part 405, Provider Reimbursement Subpart R. Review Board when Department employees appear as counsel for the intermediary.5. Appeals of CMS 42 U.S.C. 1396i...... 42 CFR Part 498. determinations that an intermediate care facility for the mentally retarded (ICFMR) no longer qualifies as an ICFMR for Medicaid purposes.6. Proceedings to impose 42 U.S.C. 1395i- 42 CFR Part 1003. civil monetary penalties, 3(h)(2)(B)(ii); assessments, or exclusions 1395l(q)(2)(B)(i); from Medicare and State 1395m(a)(11)(A), health care programs. (c)(4)(C); 1395w- 2(b)(2)(A); 1395w- 4(g)(1), (g)(3)(B), (g)(4)(B)(ii); 1395nn(g)(5); 1395ss(a)(2), (p)(8), (p)(9)(C), (q)(5)(C), (r)(6)(A), (s)(3), (t)(2); 1395bbb(f)(2)(A); 1396r(h)(3)(C)(ii); 1396r-8(b)(3)(B), (C)(ii); 1396t(j)(2)(C); 1396u(h)(2).7. Appeals of exclusions from 42 U.S.C. 42 CFR Part 498; Medicare and State health 1395l(q)(2)(B)(ii); 42 CFR 1001.107. care programs and/or other 1395m(a)(11)(A), programs under the Social (c)(5)(C); 1395w- Security Act. 4(g)(1), (g)(3)(B), (g)(4)(B)(ii).------------------------------------------------------------------------ Food and Drug Administration------------------------------------------------------------------------1. Proceedings to withdraw 21 U.S.C. 355(e)..... 21 CFR Part 12; 21 approval of new drug CFR 314.200. applications.2. Proceedings to withdraw 21 U.S.C. 360b(e), 21 CFR Part 12; 21 approval of new animal drug (m). CFR Part 514, applications and medicated Subpart B. feed applications.3. Proceedings to withdraw 21 U.S.C. 306e(e), 21 CFR Part 12. approval of medical device (g). premarket approval applications.------------------------------------------------------------------------ Office for Civil Rights------------------------------------------------------------------------1. Proceedings to enforce 42 U.S.C. 2000d-1.... 45 CFR 80.9. Title VI of the Civil Rights Act of 1964, which prohibits discrimination on the basis of race, color or national origin by recipients of Federal financial assistance.2. Proceedings to enforce 29 U.S.C. 794a; 42 45 CFR 84.61. section 504 of the U.S.C. 2000d-1. Rehabilitation Act of 1973, which prohibits discrimination on the basis of handicap by recipients of Federal financial assistance.3. Proceedings to enforce the 42 U.S.C. 6104(a).... 45 CFR 91.47. Age Discrimination Act of 1975, which prohibits discrimination on the basis of age by recipients of Federal financial assistance.4. Proceedings to enforce 20 U.S.C. 1682....... 45 CFR 86.71. Title IX of the Education Amendments of 1972, which prohibits discrimination on the basis of sex in certain education programs by recipients of Federal financial assistance.------------------------------------------------------------------------
