(a) The purpose of this subpart is to implement the notice and hearing procedures applicable to a determination by the Attorney General or the Attorney General's designee under 42 U.S.C. 233(i) that an individual health care provider shall not be deemed an employee of the Public Health Service for purposes of 42 U.S.C. 233(g) or any other statute that confers deemed Public Health Service employee status to which 42 U.S.C. 233(i) has been made applicable. Under 42 U.S.C. 233(i), an individual health care provider who is no longer deemed to be an employee of the Public Health Service is excluded from any malpractice protections otherwise made statutorily available to individuals deemed to be Public Health Service employees.

(b) Section 233(i) of title 42 provides that the Attorney General, in consultation with the Secretary of Health and Human Services, may on the record determine, after notice and an opportunity for a full and fair hearing, that an individual physician or other licensed or certified health care practitioner who is an officer, employee, or contractor of an entity described in 42 U.S.C. 233(g)(4) shall not be deemed to be an employee of the Public Health Service for purposes of 42 U.S.C. 233 if treating such individual as such an employee would expose the Government to an unreasonably high degree of risk of loss.

As used in this subpart:

Adjudicating official means the Assistant Attorney General for the Civil Division of the Department of Justice or a designee of the Assistant Attorney General.

Entity means an entity described in 42 U.S.C. 233(g)(4).

Individual means an individual physician or other licensed or certified health care practitioner who is or was an officer, employee, or contractor of an entity described in 42 U.S.C. 233(g)(4); a health professional, officer, employee, or contractor of a free clinic as described in 42 U.S.C. 233(o); or a health professional volunteer as described in 42 U.S.C. 233(q).

Initiating official means a Deputy Assistant Attorney General of the Civil Division of the Department of Justice or a designee of a Deputy Assistant Attorney General.

Parties means an individual, as defined in paragraph (c) of this section, and the initiating official, as defined in paragraph (d) of this section.

Public Health Service means the Public Health Service or an operating division or component of the Public Health Service.

Secretary means the Secretary of Health and Human Services or the Secretary's designee.

Unreasonably high degree of risk of loss is a determination based on consideration of one or more of the following statutory criteria—

(1) The individual does not comply with the policies and procedures that the entity or the sponsoring free clinic has implemented pursuant to 42 U.S.C. 233(h)(1);

(2) The individual has a history of claims filed against him or her as provided for under 42 U.S.C. 233 that is outside the norm for licensed or certified health care practitioners within the same specialty;

(3) The individual refused to reasonably cooperate with the Attorney General in defending against any such claim;

(4) The individual provided false information relevant to the individual's performance of his or her duties to the Secretary, the Attorney General, or an applicant for or recipient of funds under title 42, chapter 6A, United States Code; or

(5) The individual was the subject of disciplinary action taken by a State medical licensing authority or a State or national professional society.

(a) Whenever the initiating official, in consultation with the Secretary, finds, based upon available information gathered or provided, that treating an individual as an employee of the Public Health Service may expose the Government to an unreasonably high degree of risk of loss, the initiating official shall notify the individual that an administrative hearing will be conducted for the purpose of determining whether treating the individual as an employee of the Public Health Service for purposes of 42 U.S.C. 233 would expose the United States to an unreasonably high degree of risk of loss.

(b) The notice of hearing shall be in writing and shall be sent by registered or certified mail to the individual at the individual's last known address, or to the individual's attorney in the event the Attorney General has received written notice that the individual has retained counsel.

(c) The notice shall contain:

(1) A statement of the nature and purpose of the hearing;

(2) The factual allegations and, where appropriate, the law asserted in support of the proposed action;

(3) The name of the administrative law judge;

(4) A statement of the nature of the action proposed to be taken; and

(5) A statement of the time, date, and location of the hearing.

(d) The hearing shall be initiated not sooner than 60 days of the date on the written notice of hearing.

(a) An administrative law judge appointed in accordance with 5 U.S.C. 3105 shall preside over the hearing.

(b) Pursuant to 5 U.S.C. 556(b), the administrative law judge is to conduct all proceedings in an impartial manner. The administrative law judge may disqualify himself at any time. An individual may move to disqualify the appointed administrative law judge only upon the filing, in good faith, of a timely and sufficient affidavit of personal bias or other ground for disqualification of the administrative law judge, such as conflict of interest or financial interest. If such affidavit is timely filed, the adjudicating official shall determine the matter as part of the record and final determination in the case.

(c) The administrative law judge shall have the following powers:

(1) Administer oaths and affirmations;

(2) Issue subpoenas authorized by law;

(3) Rule on offers of proof and receive relevant evidence;

(4) Take depositions or have depositions taken when the ends of justice would be served;

(5) Regulate the course of the hearing;

(6) Hold conferences for the settlement or simplification of the issues by consent of the parties or by the use of alternative means of dispute resolution;

(7) Inform the parties as to the availability of one or more alternative means of dispute resolution, and encourage use of such methods;

(8) Dispose of procedural requests or similar matters;

(9) Make or recommend decisions;

(10) Require and, in the discretion of the administrative law judge, adopt proposed findings of fact, conclusions of law, and orders;

(11) Take any other action that administrative law judges are authorized by statute to take; and

(12) All powers and duties reasonably necessary to perform the functions enumerated in paragraphs (c)(1) through (11) of this section.

(d) The administrative law judge may call upon the parties to consider:

(1) Simplification or clarification of the issues;

(2) Stipulations, admissions, agreements on documents, or other understandings that will expedite conduct of the hearing;

(3) Limitation of the number of witnesses and of cumulative evidence; and

(4) Such other matters as may aid in the disposition of the case.

(e) At the discretion of the administrative law judge, parties or witnesses may participate in hearings by video conference.

(f) All hearings under this subpart shall be public unless otherwise ordered by the administrative law judge.

(g) The hearing shall be conducted in conformity with 5 U.S.C. 554-557 (sections 5-8 of the Administrative Procedure Act).

(h) The initiating official shall have the burden of going forward with the evidence and shall generally present the Government's evidence first.

(i) Technical rules of evidence shall not apply to hearings conducted pursuant to this subpart, but rules designed to assure production of the most credible evidence available and to subject testimony to cross-examination shall be applied where reasonably necessary by the administrative law judge. The administrative law judge may exclude irrelevant, immaterial, or unduly repetitious evidence. All documents and other evidence offered or taken for the record shall be open to examination by the parties, and opportunity shall be given to refute facts and arguments advanced on either side of the issues. A transcript shall be made of the oral evidence except to the extent the substance thereof is stipulated for the record.

(j) During the time a proceeding is pending before an administrative law judge, all motions shall be addressed to the administrative law judge and, if within the administrative law judge's delegated authority, shall be ruled upon. Any motion upon which the administrative law judge has no authority to rule shall be certified to the adjudicating official with a recommendation. The opposing party may answer within such time as may be designated by the administrative law judge. The administrative law judge may permit further replies by both parties.

(a) At any time after the initiation of the proceeding, the administrative law judge may order, by subpoena if necessary, the taking of a deposition and the production of relevant documents by the deponent. Such order may be entered upon a showing that the deposition is necessary for discovery purposes and that such discovery could not be accomplished by voluntary methods. Such an order may also be entered in extraordinary circumstances to preserve relevant evidence upon a showing that there is substantial reason to believe that such evidence could not be presented through a witness at the hearing. The decisive factors for a determination under this subsection, however, shall be fairness to all parties and the requirements of due process. A deposition may be taken orally or upon written questions before any person who has the power to administer oaths and shall not exceed one day of seven hours.

(b) Each deponent shall be duly sworn, and any adverse party shall have the right to cross-examine. Objections to questions or documents shall be in short form, stating the grounds upon which objections are made. The questions propounded and the answers thereto, together with all objections made (but not including argument or debate), shall be reduced to writing and certified by the person before whom the deposition was taken. Thereafter, the person taking the deposition shall forward the deposition and one copy thereof to the party at whose instance the deposition was taken and shall forward one copy to the representative of the other party.

(c) A deposition may be admitted into evidence as against any party who was present or represented at the taking of the deposition, or who had due notice thereof, if the administrative law judge finds that there are sufficient reasons for admission and that the admission of the evidence would be fair to all parties and comport with the requirements of due process.

Within a reasonable time after the close of the record of the hearings conducted under § 15.14, the administrative law judge shall certify the record to the adjudicating official and shall submit to the adjudicating official written findings of fact, conclusions of law, and a recommended decision. The administrative law judge shall promptly make copies of the findings of fact, conclusions of law, and recommended decision available to the parties and the Secretary.

(a) In hearings conducted under § 15.14, the adjudicating official shall, subject to subsection (d), make the final determination on the basis of the certified record, findings, conclusions, and recommendations presented by the administrative law judge.

(b) Prior to making a final determination, the adjudicating official shall give the parties an opportunity to submit the following, within thirty days after the submission of the administrative law judge's recommendations:

(1) Proposed findings and determinations;

(2) Exceptions to the recommendations of the administrative law judge;

(3) Supporting reasons for the exceptions or proposed findings or determinations; and

(4) Final briefs summarizing the arguments presented at the hearing.

(c) The adjudicating official shall, within a reasonable time after receiving the parties' submissions, consult with the Secretary and then make a final determination. Copies of the final determination shall be served upon each party to the proceeding. Subject to paragraph (d) of this section, the final determination made by the adjudicating official under this rule shall constitute the final agency action.

(d) Within 30 days of any final determination made by the adjudicating official, the Attorney General may exercise discretion to review the final determination. In the event the Attorney General exercises discretion to review a decision, the Attorney General's final determination shall constitute the final agency action.

(a) An individual dissatisfied with a final determination under § 15.17 may, within 30 days after the notice of the final determination is sent, request the adjudicating official to re-review the record.

(b) The adjudicating official may require that another oral hearing be held on one or more of the issues in controversy, or permit the dissatisfied party to present further evidence or argument in writing, if the adjudicating official finds that the individual has:

(1) Presented evidence or argument that is sufficiently significant to require the conduct of further proceedings; or

(2) Shown some defect in the conduct of the adjudication under this subpart sufficient to cause substantial unfairness or an erroneous finding in that adjudication.

(c) Any rehearing ordered by the adjudicating official shall be conducted pursuant to § § 15.14 through 15.16.

(a) A final determination under § 15.17 shall be provided to the Department of Health and Human Services and sent by certified or registered mail to the individual and to the entity employing or sponsoring such individual if the individual is currently an officer, employee, contractor, or health professional volunteer of an entity described in 42 U.S.C. 233(g)(4) or a health professional, officer, employee, or contractor of a free clinic described in 42 U.S.C. 233(o). In the event the individual is no longer an officer, employee, contractor, or health professional volunteer of an entity described in 42 U.S.C. 233(g)(4), or a health professional, officer, employee, or contractor of a free clinic described in 42 U.S.C. 233(o), the determination shall be sent by certified or registered mail to the individual and to the last entity described in 42 U.S.C. 233(g)(4) or free clinic described in 42 U.S.C. 233(o) at which such individual was an officer, employee, contractor, health professional volunteer, or health professional.

(b) A final determination shall be effective upon the date the written determination is received by such entity or free clinic.

(c) A final determination that an individual provider shall not be deemed to be an employee of the Public Health Service shall apply to all acts or omissions of the individual occurring after the date the adverse final determination is received by such entity or free clinic.

(d) The Attorney General will inform the National Practitioner Data Bank of any final determination under § 15.17 that an individual shall not be deemed to be an employee of the Public Health Service for purposes of 42 U.S.C. 233.

(a) Not sooner than five years after the time for rehearing has expired, and no more often than once every five years thereafter, an individual who has been the subject of a final determination under § 15.17 may petition the initiating official for reconsideration of that determination and for reinstatement. The individual bears the burden of proof and persuasion.

(b) In support of the petition for reinstatement, the individual shall submit relevant evidence relating to the period since the original proceedings under this subpart and a statement demonstrating and explaining why treating the individual as an employee of the Public Health Service for purposes of 42 U.S.C. 233 would no longer expose the United States to an unreasonably high degree of risk of loss.

(c) Upon receiving a petition for reinstatement, the initiating official shall forward the petition, together with an evaluation and recommendation on whether the petition makes a prima facie case for reinstatement, to the adjudicating official. The adjudicating official shall determine, in the adjudicating official's discretion, whether the petition makes a prima facie case that the individual provider no longer would expose the United States to an unreasonably high degree of risk of loss. The adjudicating official's determination that a petition does not make a prima facie case for reinstatement is not subject to further review.

(d) If the adjudicating official determines that a prima facie case has been made for reinstatement, an administrative law judge shall be appointed in accordance with 5 U.S.C. 3105 and shall conduct such proceedings pursuant to §§ 15.14 through 15.16 as the administrative law judge deems necessary, in the administrative law judge's discretion, to determine whether the individual has established that treating the individual as an employee of the Public Health Service for purposes of 42 U.S.C. 233 would no longer expose the United States to an unreasonably high degree of risk of loss. After conducting such proceedings as the administrative law judge deems necessary, the administrative law judge shall certify the record to the adjudicating official and shall submit written findings of fact, conclusions of law, and a recommended decision to the adjudicating official pursuant to § 15.16.

(e) Following proceedings conducted under paragraph (d) of this section, the adjudicating official shall make the final determination on the basis of the record, findings, conclusions, and recommendations presented by the administrative law judge, which shall include the record from the original determination and any petition for rehearing. Copies of the adjudicating official's final determination shall be furnished to the parties. The adjudicating official's final determination shall constitute the final agency action.

(f) A determination that an individual is reinstated pursuant to this section shall be distributed in the same manner as provided in § 15.19 and shall apply only to acts or omissions of the individual occurring after the date of the final reinstatement determination.