Process for Determining That an Individual Shall Not Be Deemed an Employee of the Public Health Service

<RULE> DEPARTMENT OF JUSTICE <CFR>28 CFR Part 15</CFR> <DEPDOC>[Docket No. CIV 150; AG Order No. 5968-2024]</DEPDOC> <RIN>RIN 1105-AB37</RIN> <SUBJECT>Process for Determining That an Individual Shall Not Be Deemed an Employee of the Public Health Service</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Department of Justice. <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> This rule sets forth a process by which the Attorney General or a designee may determine that an individual shall not be deemed an employee of the Public Health Service for purposes of medical malpractice coverage under the Public Health Service Act. The process described in this rule applies to individuals who are deemed to be Public Health Service employees, as well as any other individuals deemed to be Public Health Service employees under different statutory provisions to which the procedures set out in the Public Health Service Act have been made applicable. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This rule is effective on August 5, 2024. </EFFDATE> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> James G. Touhey, Jr., Director, Torts Branch, Civil Division, Department of Justice, Washington, DC 20530, (202) 616-4400. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> This rule finalizes, with some changes, a proposed rule that the Department of Justice (“Department”) published on this subject on March 6, 2015, at 80 FR 12104. In brief, the following changes were made to the text of the proposed rule: In § 15.11, a sentence was added to clarify that an individual who is no longer “deemed” to be an employee of the Public Health Service pursuant to section 224(i) of the Public Health Service Act, 42 U.S.C. 233(i), is excluded from medical malpractice protections otherwise available to individuals “deemed” to be Public Health Service employees under the statute that conferred the “deemed” employee status. In § 15.12, the definition of “Attorney General” for purposes of the rule was deleted as vague and unnecessary in light of the more specifically defined roles and responsibilities of the initiating official, the adjudicating official, and the administrative law judge involved in proceedings under this subpart. In § 15.13, a change was made to clarify that the initiating official's notice to an individual is intended to comply with the Administrative Procedure Act (“APA”), 5 U.S.C. 551, <E T="03">et seq.,</E> by furnishing a statement of the factual allegations and law asserted in support of the proposed action. In § 15.14, a change was made to clarify that the administrative law judge assigned to conduct a hearing under this subpart must, consistent with the APA, conduct proceedings in an impartial manner. In addition, § 15.14 now incorporates the grounds and procedure for seeking disqualification of an administrative law judge set forth in 5 U.S.C. 556(b). In §§ 15.16 and 15.20, a change was made to clarify that the administrative law judge, consistent with the APA, must certify the record to the adjudicating official for a final determination. A change was made to § 15.17 to clarify that the adjudicating official will consult with the Secretary of Health and Human Services (“Secretary”) in making a final determination. A subsection (d) was added to clarify that the Attorney General, consistent with the traditional authority of agency heads, possesses discretion to review any final determination within 30 days of its issuance. In addition, minor clarifications were made to § 15.19 to make clear that final determinations, whether upholding or rejecting the initiating official's proposed action, will be distributed to the parties in the same way. Changes were also made to the reinstatement procedures in § 15.20. Petitions for reinstatement must be submitted to the initiating official, who is responsible for forwarding the petition, along with a recommendation on whether the petition makes a prima facie case for reinstatement, to the adjudicating official. The adjudicating official is responsible for determining whether a prima facie case for reinstatement has been made. If the adjudicating official determines that a prima facie case has been made for reinstatement, an administrative law judge is appointed to conduct such proceedings as are deemed necessary to make a formal recommendation to the adjudicating official. This procedure was revised to avoid having the initiating official—who might be viewed as the adverse party in an original proceeding to de-deem an individual—exercise an unfettered gatekeeping role in determining whether that same individual's petition for reinstatement should receive a hearing. Finally, the Department notes that since the date of publication of the proposed rule on March 6, 2015, the Supreme Court held in <E T="03">Lucia</E> v. <E T="03">SEC,</E> 138 S. Ct. 2044 (2018), that administrative law judges assigned by the Securities and Exchange Commission to preside over enforcement proceedings are inferior officers of the United States who must, consistent with Article II, sec. 2, cl. 2 of the United States Constitution, be appointed by the President, a court of law, or a department head. Administrative law judges appointed to preside over proceedings under this rule are to be appointed pursuant to 5 U.S.C. 3105, which authorizes each agency to appoint as many administrative law judges as are necessary for proceedings to be conducted in accordance with 5 U.S.C. 556 and 557. Administrative law judges appointed to preside over proceedings under this rule will be appointed in a manner consistent with <E T="03">Lucia,</E> that is, appointed by an agency head. <HD SOURCE="HD1">Discussion</HD> The Federally Supported Health Centers Assistance Acts of 1992 (Pub. L. 102-501) (“FSHCAA”) and 1995 (Pub. L. 104-73) amended section 224 of the Public Health Service Act (42 U.S.C. 233) to make the Federal Tort Claims Act (“FTCA”) (28 U.S.C. 1346(b), 2672) the exclusive remedy for medical malpractice claims for personal injury or death brought against qualifying federally supported health centers and certain statutorily identified categories of individuals, to the extent that the centers and these individuals, as the case may be, have been “deemed” by the Department of Health and Human Services to be eligible for FTCA coverage and the conditions for such coverage have been satisfied. 42 U.S.C. 233(g). In 1996, the Health Insurance Portability and Accountability Act (Pub. L. 104-191) amended section 224 of the Public Health Service Act to provide that, subject to certain conditions, a “free clinic health professional” providing “a qualifying health service” for the free clinic may be “deemed” to be a Public Health Service employee eligible for FTCA coverage to the same extent as persons “deemed” to be Public Health Service employees under 42 U.S.C. 233(g). In 2010, the Patient Protection and Affordable Care Act (Pub. L. 111-148) further amended section 224 of the Public Health Service Act to add “an officer, governing board member, employee, or contractor of a free clinic . . . in providing services for the free clinic” to the statutorily identified categories of eligible individuals for this purpose. 42 U.S.C. 233(o)(1). And in 2016, the 21st Century Cures Act (Pub. L. 114-225) amended section 224 of the Public Health Service Act to provide that, subject to certain conditions, a “health professional volunteer” at an entity “deemed” to be a Public Health Service employee by virtue of 42 U.S.C. 233(g) may be “deemed” to be a Public Health Service employee eligible for FTCA coverage to the same extent as persons “deemed” to be Public Health Service employees under 42 U.S.C. 233(g). 42 U.S.C. 233(q). This rule will apply to any individual “deemed” to be a Public Health Service employee, regardless of the statutory provision under which the deemed status is obtained, provided that Congress has made the individual's “deemed” Public Health Service employee status subject to the procedures set out in 42 U.S.C. 233(i). Section 233(i) of title 42 provides that the Attorney General, in consultation with the Secretary, 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” based on one or more of the following enumerated statutory criteria: (1) the individual does not comply with the policies and procedures that the entity 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 chapter 6A of title 42; or (5) the individual was the subject of disciplinary action taken by a State medical licensing authority or a State or national professional society. 42 U.S.C. 233(i)(1). A final determination by the Attorney General under 42 U.S.C. 233(i) that an individual physician or other licensed or certified health care professional shall not be deemed to be an employee of the Public Health Service is effective when the entity employing such individual receives n ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 68k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━