[Federal Register Volume 89, Number 129 (Friday, July 5, 2024)]
[Rules and Regulations]
[Pages 55511-55520]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-14696]
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DEPARTMENT OF JUSTICE
28 CFR Part 15
[Docket No. CIV 150; AG Order No. 5968-2024]
RIN 1105-AB37
Process for Determining That an Individual Shall Not Be Deemed an
Employee of the Public Health Service
AGENCY: Department of Justice.
ACTION: Final rule.
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SUMMARY: 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.
DATES: This rule is effective on August 5, 2024.
FOR FURTHER INFORMATION CONTACT: James G. Touhey, Jr., Director, Torts
Branch, Civil Division, Department of Justice, Washington, DC 20530,
(202) 616-4400.
SUPPLEMENTARY INFORMATION: 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 Sec. 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
[[Page 55512]]
statute that conferred the ``deemed'' employee status.
In Sec. 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 Sec. 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, et seq., by
furnishing a statement of the factual allegations and law asserted in
support of the proposed action.
In Sec. 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, Sec. 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 Sec. Sec. 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 Sec. 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 Sec. 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 Sec.
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 Lucia v.
SEC, 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 Lucia, that is, appointed by an agency
head.
Discussion
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
[[Page 55513]]
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 notice of such determination, and the determination
applies only to acts or omissions occurring after the date such notice
is received. 42 U.S.C. 233(i)(2).
This rule establishes a process for creating the record and
providing the full and fair hearing before the Attorney General makes a
final determination under 42 U.S.C. 233(i).
The first step, pursuant to Sec. 15.13(a), is a finding by the
``initiating official,'' in consultation with the Secretary, 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
for one or more of the statutorily enumerated reasons in 42 U.S.C.
233(i). Under Sec. 15.12(d), the initiating official is a Deputy
Assistant Attorney General of the Department of Justice's Civil
Division or a designee of a Deputy Assistant Attorney General.
Section 15.13(a) requires the initiating official to provide notice
to the individual in question that an administrative hearing will be
held to determine whether treating the individual as an employee of the
Public Health Service would expose the Government to an unreasonably
high degree of risk of loss based upon one or more of the statutory
criteria enumerated in 42 U.S.C. 233(i). Following a period for
discovery and depositions, to the extent determined appropriate by an
administrative law judge under Sec. 15.15, the hearing is then
conducted by the administrative law judge in the manner prescribed in
Sec. 15.14. After the hearing is conducted and the record is closed,
Sec. 15.16 requires the administrative law judge to certify the record
and submit written findings of fact, conclusions of law, and a
recommended decision to the ``adjudicating official,'' who is the
Assistant Attorney General for the Department of Justice's Civil
Division or a designee of the Assistant Attorney General. Section 15.16
provides that copies of the findings of fact, conclusions of law, and
recommended decision are made available to the parties and to the
Secretary. Section 15.17(b) then gives the parties 30 days to submit
certain additional materials, including exceptions to the
administrative law judge's recommended decision, to the adjudicating
official, who then must, in consultation with the Secretary, make a
final determination whether treating the individual as an employee of
the Public Health Service for purposes of 42 U.S.C. 233 would expose
the Government to an unreasonably high degree of risk of loss based on
one or more of the criteria specified in 42 U.S.C. 233(i). The Attorney
General may exercise discretion to review any final determination
within 30 days of its issuance.
Section 15.18 provides that an individual who is dissatisfied with
the final determination may seek rehearing within 30 days after notice
of the determination is sent, and Sec. 15.20 allows individuals who
have been determined to expose the United States to an unreasonably
high degree of risk of loss to apply for reinstatement after a period
of time. Consistent with 42 U.S.C. 1320a-7e(a) and 45 CFR 60.3, 60.5(h)
and 60.16, the rule also provides that the Department will notify the
National Practitioner Data Bank (``NPDB'') of the issuance of the
Attorney General's final determination that an individual provider
shall not be deemed to be an employee of the Public Health Service
under this rule. The NPDB, which is maintained by the Health Resources
and Services Administration within the Department of Health and Human
Services, is a confidential information clearinghouse created by
Congress with primary goals of improving health care quality and
protecting the public.
Discussion of Comments
The Department received ten public comments on the proposed rule
during the comment period, which closed on May 6, 2015. Several
commenters generally supported the proposed rule as providing adequate
notice and process to reach fair decisions on whether to de-deem
individual practitioners who pose an unreasonably high degree of risk
of loss to the Government. The Department is grateful for the feedback.
Several comments were received from membership organizations of
federally supported health centers that receive Federal grant money
under 42 U.S.C. 254b, as well as one federally supported health center
that offered comments on its own behalf. These comments generally
sought additional guidance on how the rules and criteria set forth in
42 U.S.C. 233(i)(1) would be applied. A few other commenters expressed
more general concerns about the consequences of de-deeming
determinations. Summaries of these comments and the Department's
responses to them are set forth below.
1. Some commenters requested that the Department provide additional
guidance on how the statutory criteria for determining whether treating
an individual physician or certified health care provider as a Public
Health Service employee exposes the Government to an ``unreasonably
high degree of risk of loss'' will be applied. These commenters
requested that clearer definitions be adopted and that specific
examples be provided for how each of the criteria set forth in 42
U.S.C. 233(i)(A)-(E) will be weighed and considered.
Response: The Department does not adopt the changes suggested in
these comments. The purpose of these regulations is procedural: to
establish the process and procedures used to create a record and
provide an individual medical provider the opportunity for the ``full
and fair hearing'' required by section 233(i)(1) before the Attorney
General makes a ``final determination'' that an individual ``shall not
be deemed to be'' an employee of the Public Health Service for purposes
of 42 U.S.C. 233. The Department is not undertaking, at this time, a
regulatory effort to interpret or re-interpret the statutory criteria
that Congress established more than 20 years ago to govern such
determinations.
Section 233(i) requires a full and fair hearing to determine
whether any one of these factors or combination of factors supports a
determination that treating an individual physician or certified health
care provider as a Public Health Service employee poses an
``unreasonably high degree of risk of loss'' to the Government.
The commenters recognized that ``strict definitions'' for these
criteria would be impracticable. The Department agrees with the
commenters. In addition to the impracticality of adopting strict
definitions, the Department also observes that the application of the
criteria set forth in the statute will necessarily depend on the
specific facts and circumstances of each individual case.
2. Some commenters requested that the Department expand the scope
of the regulations to specify the form and substance of the
consultation that the Attorney General undertakes with the Secretary
before finding that an individual should be provided notice of a
hearing to determine whether treating
[[Page 55514]]
that individual as an employee of the Public Health Service poses an
unreasonable risk of loss to the Government.
Response: The Department does not adopt the change suggested in
these comments. The statute does not require that the Department's
regulations specify the form and substance of the Attorney General's
consultation with the Secretary. Moreover, a requirement for public
disclosure of such consultations would not be warranted given the
predecisional, deliberative nature of the consultation process between
agencies.
3. Some commenters requested that the Department, when notifying an
individual that a proceeding has been initiated under 42 U.S.C. 233(i),
be required to provide both the specific information upon which the
Department will rely and the standards that will apply for evaluating
the criteria set forth in 42 U.S.C. 233(i). The commenters suggested
that providing such information in the hearing notice would reduce
discovery costs and increase efficiency of the hearing process.
Response: In response to these comments, the Department has added
language in Sec. 15.13(c) to clarify that the notice provided to
individuals will set forth the factual allegations supporting the
initiating official's proposed action, consistent with the requirements
for notice under 5 U.S.C. 554(b). Thus, in addition to providing a
statement of the nature and purpose of the hearing, the name of the
administrative law judge who will preside, a statement of the nature of
the action proposed to be taken, and a statement of the time, date, and
location of the hearing for the individual to be heard, the notice will
also provide a statement of the facts and, where appropriate, the law
asserted in support of the proposed action. 28 CFR 15.13(c). The
administrative law judge is vested with all powers necessary to reduce
discovery costs and increase the efficiency of the process through
exchanges of information and narrowing of issues. 28 CFR 15.14-.15. As
for the further comment requesting additional information about the
standards that will apply for evaluating the criteria set forth in 42
U.S.C. 233(i), the Department does not adopt the change requested in
this comment for the reasons already expressed above.
4. One commenter requested that the Department state the period of
time after which a de-deemed practitioner may apply for reinstatement.
Response: The final rule provides that a de-deemed practitioner may
apply for reinstatement not sooner than five years after the time for
seeking rehearing of the initial determination to de-deem a
practitioner has expired. 28 CFR 15.20(a).
5. One commenter requested that the Department clarify the events
and informational exchanges that will or could set into the motion the
de-deeming process.
Response: The statute and final rule provide this information. When
the Department's initiating official, in consultation with the
Secretary, finds, based upon a review of available information, 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
based on one or more of the criteria enumerated in 42 U.S.C. 233(i),
the de-deeming process is initiated by issuing a notice for an
administrative hearing to determine whether that individual should be
de-deemed. 42 U.S.C. 233(i)(1); 28 CFR 15.13. The notice will set forth
the facts, and where applicable, the law upon which the proposed action
is based.
6. A few commenters expressed concern that the de-deeming process
could be initiated to rescind FTCA coverage while a lawsuit was pending
and requested that the rule allow only for prospective de-deeming.
Another commenter suggested adoption of a ``safety period''--a
designated period of time during which a ``deemed'' employee cannot be
subject to ``de-deeming''--that would apply where litigation is
anticipated involving acts or omissions of a practitioner who has been
deemed to be an employee of the Public Health Service.
Response: The Department agrees that de-deeming should be
prospective only (as the statute requires) but does not adopt the
``safety period'' suggestion. The statute provides that the Attorney
General's decision to de-deem an individual shall apply only to acts or
omissions occurring after the date that notice of the Attorney
General's final determination that an individual not be deemed to be a
Public Health Service employee is received. 42 U.S.C. 233(i)(2). The
final regulations therefore provide in Sec. 15.19(c) that a final
agency 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 the relevant entity or free clinic. The
final regulations similarly provide in Sec. 15.20(f) that a
determination that an individual is reinstated pursuant to this section
. . . shall apply only to acts or omissions of the individual occurring
after the date of the final reinstatement determination. There is no
need to adopt the suggested ``safety period.'' If a lawsuit is pending,
or even anticipated, then the acts or omissions giving rise to that
pending or anticipated suit will already have occurred. The Attorney
General's ``de-deeming'' determination does not apply to acts or
omissions that occurred before the de-deeming determination becomes
final, and reinstatement determinations similarly apply only to acts or
omissions that occur after reinstatement.
7. One commenter expressed concern that the proposed rule might
have untoward consequences, such as difficulty in securing quality
replacement personnel or loss of liability coverage while a lawsuit is
pending.
Response: The Department does not adopt further changes in response
to these comments. There should be no loss of liability coverage while
a lawsuit is pending, as the Attorney General's final determination
that a practitioner is de-deemed is effective only as to acts or
omissions that occur after such a determination is received by the
entity employing that practitioner. 42 U.S.C. 233(i)(2). Moreover, a
final de-deeming determination is applicable only to the individual who
was subject to the hearing and final determination.
The Attorney General's de-deeming determination does not require or
compel a health center to terminate a practitioner. Entities may choose
to employ ``de-deemed'' practitioners, but they can no longer rely on
the protections of 42 U.S.C. 233(g) or similar statutes, as the case
may be, as a substitute for medical malpractice liability coverage for
that practitioner if that practitioner is subject to a medical
malpractice claim for acts or omissions occurring after receipt of a
final de-deeming determination, for so long as the final determination
remains effective. Congress's decision to authorize the Attorney
General to de-deem individual practitioners reflects a policy judgment
that, if an individual practitioner exposes the Government to an
unreasonably high degree of risk of loss based on any of the statutory
criteria enumerated in 42 U.S.C. 233(i), insuring against that risk or
finding a suitable replacement should fall upon the entity responsible
for hiring and retaining the practitioners or the sponsoring free
clinic, not the United States. Qualifying health centers that receive
Federal grants pursuant to 42 U.S.C. 254b may purchase ``tail,''
``gap,'' or ``wrap-around'' insurance to cover claims for which
liability protections under 42 U.S.C. 233(g) or similar
[[Page 55515]]
statutes, as the case may be, are inapplicable.
8. One commenter expressed concern that final determinations are
vested in the Attorney General or the Attorney General's designee and
suggested that the recommendations of the presiding administrative law
judge be binding or that three-judge panels be established for purposes
of making final determinations.
Response: The Department does not adopt the changes requested in
this comment. Under 42 U.S.C. 233(i), the ``final determination'' on
whether to de-deem an individual ``under this subsection'' is vested in
the ``Attorney General.'' The Department is not free to re-write the
statute. Moreover, because section 233(i) provides that the Attorney
General's final determination shall be made ``on the record'' ``after
notice and an opportunity for a full and fair hearing,'' the provisions
of sections 554, 556, and 557 of the APA are applicable to these
hearings. See 5 U.S.C. 554(a), (c)(2) (section 554 applies ``in every
case of adjudication required by statute to be determined on the record
after opportunity for an agency hearing''; such hearings and decisions
on contested issues are to be conducted ``in accordance with sections
556 and 557''). This rule provides for a hearing and recommended
decision by an administrative law judge and a final determination by
the agency, consistent with the foregoing provisions of the APA. Any
review of the Attorney General's ``final determination'' is governed by
the APA, so further review of that final determination by an Article
III court is possible. The Department also declines to render the
presiding administrative law judge's decision binding. Providing for a
recommended decision that is further reviewed by the adjudicating
official, with discretionary review by the Attorney General, adds
further layers of review and therefore reduces the risk of an erroneous
determination.
Regulatory Flexibility Act
The Attorney General, in accordance with the Regulatory Flexibility
Act, 5 U.S.C. 605(b), has reviewed this final rule and, by approving
it, certifies that it will not have a significant economic impact on a
substantial number of small entities because it pertains to personnel
and administrative matters affecting the Department. This rule merely
sets forth the process for a hearing used to determine whether certain
individual health care providers should no longer be ``deemed'' to be
``employees of the Public Health Service,'' thus excluding such
individual health care providers from eligibility for the medical
malpractice liability protections under 42 U.S.C. 233(g), (o), or (q).
The rule does not adopt substantive standards and therefore will not
have a significant impact on regulated parties.
Executive Orders 12866, 13563, and 14094: Regulatory Planning and
Review
This final rule has been drafted and reviewed in accordance with
Executive Order 12866, ``Regulatory Planning and Review,'' Executive
Order 13563, ``Improving Regulation and Regulatory Review,'' and
Executive Order 14094, ``Modernizing Regulatory Review.'' The Office of
Management and Budget has determined that this final rule is a
``significant regulatory action'' under Executive Order 12866, section
3(f), and accordingly this final rule has been reviewed by the Office
of Management and Budget. Executive Orders 12866 and 13563 direct
agencies to assess all costs and benefits of available regulatory
alternatives and, if regulation is necessary, to select regulatory
approaches that maximize net benefits (including potential economic,
environmental, public health and safety, and other advantages;
distributive impacts; and equity). Executive Order 13563 emphasizes the
importance of quantifying both costs and benefits, of reducing costs,
of harmonizing rules, and of promoting flexibility.
The Department has assessed the costs and benefits of this final
rule and believes that its benefits justify its costs.
As an initial matter, this final rule only establishes a process
for removing a statutorily conferred deemed status applicable to an
individual provider who is determined to expose the Government to an
unreasonably high degree of risk of loss for one or more statutorily
enumerated reasons. As further explained below, Congress expressly
granted the Attorney General the authority to de-deem certain
individual physicians or other licensed or certified health care
practitioners, provided that certain procedural safeguards were in
place. This rule establishes those safeguards. The process will impose
some costs on both the government and the individuals who are subject
to proceedings under 42 U.S.C. 233(i). But the net benefit is to reduce
the potential for incorrect de-deeming decisions, to ensure that a de-
deeming decision is based upon a developed record, and to provide the
individual provider an opportunity to participate in the process. On
balance, the Department believes these benefits outweigh the costs and
will contribute to just decisions.
Congress expressly provided the Attorney General with the authority
to exclude individuals who expose the Government to an unreasonably
high degree of risk of loss based upon one or more statutory criteria
from the malpractice protections afforded under 42 U.S.C. 233(g) and
similar statutes. A statutory provision granting the Attorney General
authority to exclude an individual provider has existed since the
FSHCAA was first enacted in 1992. This provision was specifically
designed to ``assure that FTCA coverage is not extended to individual
practitioners that do not provide care of acceptable quality'' when the
Attorney General determines that such individuals ``expose the U.S. to
an unreasonably high degree of risk of loss.'' H.R. Rep. No. 102-823,
pt. 2, at 8 (1992).
When the FSHCAA was amended and extended in 1995, Congress
continued to include the provision authorizing the Attorney General to
exclude an individual provider, adding language to clarify that an
individual provider's ``coverage'' under the FSHCAA would be removed
only after receiving notice and an opportunity for a full and fair
hearing, with all decisions to be made ``on the record.'' H.R. Rep. No.
104-398, at 13 (1995); Public Law 104-73, sec. 9, 109 Stat. 777, 781
(1995).
In light of the foregoing, this final rule assures the procedural
protections Congress intended, without altering Congress's objective
that certain individual providers be subject to exclusion from the
malpractice liability protections under 42 U.S.C. 233 if they expose
the Government to an unreasonably high degree of risk of loss based on
the enumerated statutory criteria. Congress already has established
that the benefits of excluding certain providers outweigh the costs if
procedural protections are afforded and the final decision is supported
by one or more of the criteria specified in 42 U.S.C. 233(i).
The Department does not expect that the process created by the
final rule will have systemic or large-scale costs because it is only
the rare individual provider who would be subject to the procedures
under this rule based on the statutory criteria of 42 U.S.C. 233(i);
proceedings against an individual provider under this rule are expected
to be infrequent and will, therefore, affect only a small fraction of
providers, health centers, or, potentially, their patients.
The majority of costs associated with the final rule, then, would
come in the individual instances of its application, which are not
feasible to predict. The
[[Page 55516]]
administrative process will impose some defense costs on the particular
individual who is the subject of the hearing, but Sec. Sec. 15.14 and
15.15 provide flexibility that may enable the parties and
administrative law judges to avoid unduly burdensome costs when those
costs are unnecessary.
While it is not feasible to estimate these costs with precision,
the Department notes that the litigation costs incurred in defending
medical malpractice suits in court frequently exceed $100,000 per case.
The potential costs associated with a section 233(i) proceeding, by
contrast, are expected to be a small fraction of the cost of litigating
malpractice actions brought against individual providers. If even one
provider is excluded from malpractice protections under 42 U.S.C.
233(g) or similar statutes, potentially resulting in at least one fewer
malpractice action that the United States otherwise might have been
required to defend, the potential cost savings to the United States
will be tens of thousands of dollars on litigation expenses alone.
The Department also observes that losses in covered medical
malpractice actions against deemed centers and their personnel are
borne by the public fisc through the payment of judgments and
settlements and other expenses. Each year, the Department transmits to
the Secretary and Congress an estimate of the dollar amount of claims
and litigation for which payments are expected to be made during the
upcoming fiscal year, along with related fees and expenses. Although in
1996, it was estimated that only 14,234 individual providers were
deemed to be Public Health Service employees for purposes of
malpractice claims, that number has steadily risen, reaching in excess
of 250,000 ``deemed'' providers as of April 2022.
In addition to the increasing numbers of providers eligible for
malpractice protections under 42 U.S.C. 233(g) and similar statutes,
the amount of money paid by the United States as a result of judgments
and settlements and litigation expenses has steadily increased as well.
Since fiscal year 2014, the average annual amount sought by claimants
in malpractice losses against deemed providers has been approximately
$35 billion. To be sure, the United States pays substantially less than
the amount claimed in the majority of cases, but it still paid in
excess of $100 million in fiscal years 2017, 2018, and 2019,
respectively, including a then-record amount of $135,047,091 in 2019
alone. Fiscal years 2020 and 2021 saw a slight downturn in the number
of claims paid, likely the result of delays in court proceedings during
the COVID-19 pandemic and related restrictions. In fiscal year 2022,
with restrictions largely lifted, the United States paid
$158,338,182.79 in judgments and settlements, a new record amount.
Neither the criteria set forth in 42 U.S.C. 233(i) nor the final
rule contemplates that an individual provider subjects the Government
to an unreasonably high degree of risk of loss merely by subjecting the
United States to suit on malpractice claims that result in losses. That
is a potential basis for de-deeming only to the extent that a single
provider's care has resulted in claims outside the norm for a licensed
or certified practitioner in the same specialty. If a single provider,
for example, exposed the United States to several meritorious claims,
each costing the United States $1 million, and that provider's history
of claims was outside the norm for a practitioner in the same
specialty, then excluding that provider from the malpractice liability
protections of 42 U.S.C. 233(g) or another statute, as the case may be,
may result in substantial savings to the United States in the future.
That is because de-deeming the provider will reduce the number of
claims and the amount of losses the United States would otherwise have
incurred as a result of that provider's care and treatment.
The Department further notes that, unlike with actual Federal
employees, over whom Federal agencies exercise plenary control and have
various means of addressing risk through disciplinary action or
termination, individual providers deemed to be Public Health Service
employees for purposes of covered malpractice claims remain under the
exclusive control and supervision of the public or non-profit private
entity that employs them. The Government has no role in the day-to-day
operations of health centers or free clinics and no involvement in the
employment or disciplinary decisions of such entities.
The Attorney General's authority to exclude an individual provider
who poses an unreasonably high degree of risk of loss through a section
233(i) proceeding provides the United States some small measure of risk
control. Moreover, the authority granted to the Attorney General under
section 233(i) is, in practice, no different from the authority that a
private insurance carrier could exercise to refuse to insure an
individual provider who poses an unreasonably high degree of risk of
loss. A section 233(i) proceeding to exclude an individual provider
from coverage under 42 U.S.C. 233(g) or similar statutes, if it is
determined that the individual provider poses an unreasonably high
degree or risk of loss, is similar to the ability that a private
insurer possesses to exclude from coverage individual providers for the
same reasons.
In the event that treating an individual provider as a Public
Health Service employee is ultimately determined to expose the United
States to an unreasonably high degree of risk of loss, the Department
acknowledges that there will be certain costs to that provider. An
individual provider who is no longer deemed to be an employee of the
Public Health Service for purposes of malpractice claims may, for
example, be required to obtain personal medical malpractice insurance
to continue practicing. The provider may also experience negative
employment consequences as a result of the Attorney General's
determination.
For several reasons, it is not feasible to estimate the costs to
specific, individual providers of having to procure malpractice
insurance in lieu of relying on deemed Public Health Service employee
status for malpractice protection. Malpractice insurance rates vary
greatly depending on factors like specialty and location, insurance
provider, loss history, coverage requirements, policy limits, and
policy type.\1\ Even within States, coverage costs can vary from county
to county depending on factors like population density and the density
of the physician population in a given area.
---------------------------------------------------------------------------
\1\ See Gallagher Healthcare, How Much Does Medical Malpractice
Insurance Cost? (March 19, 2020), https://www.gallaghermalpractice.com/blog/post/how-much-does-medical-malpractice-insurance-cost.
---------------------------------------------------------------------------
For example, State-filed malpractice premiums, before applied
insurer discounts, average between roughly $2,486 and $15,949 in
Nebraska, but between roughly $10,560 and $161,942 in New York, with
higher premiums for higher-risk specialties.\2\ Compared to the average
loss to the United States in malpractice actions brought under 42
U.S.C. 233(g) and related statutes, which in the first half of fiscal
year 2022 averaged $1,064,767 per claim paid, the net benefit to the
United States of excluding an individual provider who poses an
unreasonably high degree of risk of loss to the United States justifies
[[Page 55517]]
the potential costs to that provider of procuring personal insurance.
---------------------------------------------------------------------------
\2\ Compare Gallagher Health Care, Nebraska Medical Malpractice
Insurance, https://www.gallaghermalpractice.com/state-resources/nebraska-medical-malpractice-insurance (last visited January 26,
2024), with New York Medical Malpractice Insurance,
www.gallaghermalpractice.com/state-resources/new-york-medical-malpractice-insurance (last visited January 26, 2024).
---------------------------------------------------------------------------
The Department further observes that, while premiums may vary by
location or specialty, an individual provider subject to a proceeding
governed by this rule could come from any location or specialty; the
only factor common to a provider subject to a proceeding under this
rule will be a threshold finding, triggering the process under this
rule, that the provider may expose the United States to an unreasonably
high degree of risk of loss. Any provider who is excluded from coverage
by a final determination made under 42 U.S.C. 233(i) would merely be
placed in the position that provider would have occupied but for the
existence of these statutes--that of a provider who must procure
personal insurance. If a provider turns out to be uninsurable in the
private insurance market, that provider's inability to procure
insurance merely underscores that the provider poses an unreasonably
high degree of risk of loss. Congress conferred upon the Attorney
General the authority to de-deem certain individuals in order to
protect against such an unreasonably high risk of loss. 42 U.S.C.
233(i); H.R. Rep. No. 102-823, pt. 2, at 8 (1992).
The Department acknowledges as well that if an individual provider
is no longer deemed to be an employee of the Public Health Service and
leaves the practice, the health center or free clinic may incur costs
to find a new provider. Replacing providers, however, may occur even
absent this final rule establishing a process for de-deeming individual
providers, and the costs to entities of filling positions may not be
readily traceable to the process established by this final rule.
In any event, the Department expects that substantial benefits will
justify any costs incurred in finding replacements, as any individual
who is replaced after being excluded from coverage following a
proceeding under this rule will be one who has been determined to
create an unreasonably high degree of risk of loss on claims for
malpractice. It is anticipated that, in the usual case, the
individual's replacement will provide reduced risk of loss for the
United States and better care for patients. While there may be
instances in which an individual who presented such a risk of loss
cannot be replaced, the Department believes that these costs are
justified by the benefits of implementing this rule to carry out
Congress's stated objectives. Congress enacted 42 U.S.C. 233(i) ``to
assure that FTCA coverage is not extended to individual practitioners
that do not provide care of acceptable quality'' by providing a process
whereby the Attorney General may exclude individuals based on a
determination that such individuals ``expose the U.S. to an
unreasonably high degree of risk of loss.'' H.R. Rep. No. 102-823, pt.
2, at 8 (1992). Implementing the process for section 233(i) proceedings
through this final rule is a procedural step toward effectuating
Congress's purpose in enacting section 233(i).
Based on the expectation that the process will be used sparingly
and only for an individual provider who exposes the United States to an
unreasonably high degree of risk of loss on medical malpractice claims
for personal injury or death, the Department has concluded that the net
benefits of improved patient care and reduced losses to the United
States traceable to malpractice claims justify the potential costs of
implementing a process to carry out 42 U.S.C. 233(i).
Executive Order 13132: Federalism
This final rule will not have substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Therefore, in accordance with Executive
Order 13132, the Department of Justice has determined that this final
rule will not have sufficient federalism implications to warrant the
preparation of a federalism summary impact statement.
Executive Order 12988: Civil Justice Reform
This final rule meets the applicable standards provided in sections
3(a) and 3(b)(2) of Executive Order 12988.
Unfunded Mandates Reform Act of 1995
This final rule will not result in the expenditure by State, local,
and Tribal governments, in the aggregate, or by the private sector, of
$100 million or more in any one year, and it will not significantly or
uniquely affect small governments. Therefore, no actions are deemed
necessary under the provisions of the Unfunded Mandates Reform Act of
1995, 2 U.S.C. 1501 et seq.
Small Business Regulatory Enforcement Fairness Act of 1996
This final rule is not a major rule as defined by section 251 of
the Small Business Regulatory Enforcement Fairness Act of 1996, 5
U.S.C. 804. This final rule will not result in an annual effect on the
economy of $100 million or more; a major increase in cost or prices;
significant adverse effects on competition, employment, investment,
productivity, or innovation; or significant adverse effects on the
ability of United States-based enterprises to compete with foreign-
based enterprises in domestic and export markets.
List of Subjects in 28 CFR Part 15
Claims, Government contracts, Government employees, Health care,
Immunization, Nuclear energy.
For the reasons set forth in the preamble, the Attorney General
amends part 15 of title 28 of the Code of Federal Regulations as
follows:
PART 15--CERTIFICATIONS, DECERTIFICATIONS, AND NON-DEEMING
DETERMINATIONS FOR PURPOSES OF THE FEDERAL TORT CLAIMS ACT
0
1. The authority citation for part 15 is revised to read as follows:
Authority: 5 U.S.C. 301, 554, 556, 557, and 8477(e)(4); 10
U.S.C. 1054, 1089; 22 U.S.C. 2702, 28 U.S.C. 509, 510, and 2679; 38
U.S.C. 7316; 42 U.S.C. 233, 2212, 2458a, and 5055(f); and sec. 2,
Pub. L. 94-380, 90 Stat. 1113 (1976).
0
2. The heading for part 15 is revised to read as set forth above.
0
3. Designate Sec. Sec. 15.1 through 15.4 as subpart A under the
following heading:
Subpart A--Certification and Decertification in Connection With
Certain Suits Based Upon Acts or Omissions of Federal Employees and
Other Persons
Sec. Sec. 15.5 through 15.10 [Reserved]
0
4. Add reserved Sec. Sec. 15.5 through 15.10 to newly designated
subpart A.
0
5. Add subpart B to read as follows:
Subpart B--Determination of Individuals Deemed Not To Be Employees
of the Public Health Service
Sec.
15.11 Purpose.
15.12 Definitions.
15.13 Notice of hearing.
15.14 Conduct of hearing.
15.15 Discovery.
15.16 Recommended decision.
15.17 Final determination.
15.18 Rehearing.
15.19 Effective date of a final determination.
15.20 Reinstatement.
Subpart B--Determination of Individuals Deemed Not To Be Employees
of the Public Health Service
Sec. 15.11 Purpose.
(a) The purpose of this subpart is to implement the notice and
hearing
[[Page 55518]]
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.
Sec. 15.12 Definitions.
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.
Sec. 15.13 Notice of hearing.
(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.
Sec. 15.14 Conduct 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;
[[Page 55519]]
(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.
Sec. 15.15 Discovery.
(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.
Sec. 15.16 Recommended decision.
Within a reasonable time after the close of the record of the
hearings conducted under Sec. 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.
Sec. 15.17 Final determination.
(a) In hearings conducted under Sec. 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.
Sec. 15.18 Rehearing.
(a) An individual dissatisfied with a final determination under
Sec. 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 Sec. Sec. 15.14 through 15.16.
Sec. 15.19 Effective date of a final determination.
(a) A final determination under Sec. 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
[[Page 55520]]
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 Sec. 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.
Sec. 15.20 Reinstatement.
(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
Sec. 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 Sec. Sec. 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
Sec. 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
Sec. 15.19 and shall apply only to acts or omissions of the individual
occurring after the date of the final reinstatement determination.
Dated: June 28, 2024.
Merrick B. Garland,
Attorney General.
[FR Doc. 2024-14696 Filed 7-3-24; 8:45 am]
BILLING CODE 4410-12-P