[Federal Register Volume 78, Number 184 (Monday, September 23, 2013)]
[Rules and Regulations]
[Pages 58202-58204]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-22993]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 6

RIN 0906-AA77


Federal Tort Claims Act (FTCA) Medical Malpractice Program 
Regulations: Clarification of FTCA Coverage for Services Provided to 
Non-Health Center Patients

AGENCY: Health Resources and Services Administration (HRSA), HHS.

ACTION: Final rule.

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SUMMARY: This final rule amends the current regulatory text of the 
regulations for FTCA Coverage of Certain Grantees and Individuals with 
the key text and examples of activities that have been determined, 
consistent with provisions of the existing regulation, to be covered by 
the FTCA, as previously published in the September 25, 1995 Federal 
Register Notice (September 1995 Notice). Additionally, HRSA has added 
examples of services covered under the FTCA involving individual 
emergency care provided to a non-health center patient and updated the 
September 1995 Notice immunization example to include events to 
immunize individuals against infectious illnesses. The amended 
regulation will supersede the September 1995 Notice.

DATES: Effective Date: The amendments in this final rule are effective 
December 23, 2013.

FOR FURTHER INFORMATION CONTACT: Suma Nair, Director, Office of Quality 
and Data, Bureau of Primary Health Care, Health Resources and Services 
Administration, U.S. Department of Health and Human Services, 5600 
Fishers Lane, Room 6A-55, Rockville, Maryland 20857; Phone: (301) 594-
0818.

SUPPLEMENTARY INFORMATION:

A. Background

    Section 224(a) of the Public Health Service (PHS) Act (42 U.S.C. 
233(a)) provides that the remedy against the United States under the 
Federal Tort Claims Act (FTCA) for damage for personal injury, 
including death, resulting from the performance of medical, surgical, 
dental, or related functions by any commissioned officer or employee of 
the PHS while acting within the scope of his office or employment, 
shall be exclusive of any other related civil action or proceeding. The 
Federally Supported Health Centers Assistance Act of 1992 (Public Law 
102-501), as amended in 1995 (FSHCAA) (42 U.S.C. 233(g)-(n)), provides 
that, subject to its provisions, certain entities receiving funds under 
section 330 of the PHS Act, as well as any officers, governing board 
members, employees, and certain contractors of these entities, may be 
deemed by the Secretary to be employees of the PHS for the purposes of 
this medical malpractice liability protection.
    A final rule implementing Public Law 102-501 was published in the 
Federal Register (60 FR 22530) on May 8, 1995, and added a new part 6 
to 42 CFR Chapter I, Subchapter A. This rule describes the eligible 
entities and the covered individuals who are or may be determined by 
the Secretary to be within the scope of the FTCA protection afforded by 
the Act.
    Section 6.6, also published in the May 8, 1995 rule, describes acts 
and omissions that are covered by FSHCAA (covered activities or covered 
services). The language of subsection 6.6(d) matches the statutory 
criteria that may support a determination of coverage for services 
provided to individuals who are not patients of the covered entity.
    Subsection 6.6(e) provides examples of situations within the scope 
of subsection 6.6(d). Questions were raised, however, about the 
specific situations encompassed by 6.6(d) and 6.6(e) and about the 
process for the Secretary to make the determinations provided by those 
subsections. In response, HRSA decided that it would be impractical and 
burdensome to require a separate application and determination of 
coverage for certain situations described in the examples set forth in 
6.6(e), as further discussed in the September 1995 Notice (60 FR 
49417). For those situations, it was determined that the activities 
described in the September 1995 Notice are covered under 42 CFR 6.6(d) 
without the need for a separate application, so long as other 
requirements for coverage are met, such as a determination that the 
entity is a covered entity, a determination that the individual is a 
covered individual, and a determination that the acts or omissions by 
those individuals occur within the scope of employment.

B. Notice of Proposed Rulemaking

    HRSA published a Notice of Proposed Rulemaking (NPRM) on February 
28, 2011. The NPRM proposed:
    (1) To replace the current regulatory text at 42 CFR 6.6(e) of the 
regulations at 42 CFR part 6 (``FTCA Coverage of Certain Grantees and 
Individuals'') with key text and examples of activities that have been 
determined, consistent with provisions of the existing regulation, to 
be covered by FTCA, as previously published in the September 1995 
Notice, in 42 CFR 6.6(e);
    (2) To update the ``Immunization Campaign'' example to clarify that 
this covered situation includes events to immunize individuals against 
infectious illnesses and does not limit coverage to childhood 
vaccinations; and
    (3) To add the following new example as subsection 6.6(e)(4) to set 
forth its determination of FTCA coverage for services rendered to non-
health center patients in certain individual emergency situations. This 
addition is expected to provide assurance of FTCA coverage in these 
situations and encourage reciprocal assistance by non-health center 
clinicians for health center patients in similar emergencies.

C. Comments in Response to the NPRM

    HRSA received comments from 12 organizations and individuals in 
response to the NPRM. All of the comments submitted were in favor of 
the proposed rule. The major comments are summarized as follows:
    (1) Clarify whether health centers that participate in health fairs 
are covered: Several commentators requested that HRSA modify Paragraph 
6.6(e)(1)(iii) to clarify that health centers that conduct or 
participate in health fairs are covered.
    (2) Clarify whether health centers that participate in immunization 
campaigns are covered:

Several commentators requested that HRSA modify paragraph 
6.6(e)(1)(iv), Immunization Campaigns, to clarify that health centers 
that conduct or participate in immunization campaigns are covered.
    (3) Amend the proposed new paragraph 6.6(e)(4), addressing 
individual emergency situations, by adding the term ``urgent 
situations,'' and the phrase, ``as determined by the health center 
provider at the scene of the incident:''
Several commentators requested that HRSA modify proposed paragraph 
6.6(e)(4) to include urgent situations and to more clearly define what 
would constitute an emergency or urgent situation. Additionally, 
commentators requested that the phrase, ``as determined by the health 
center provider at the scene of the incident,'' also be added to 6.6 
(e)(4).
    (4) Clarify, define, and/or delete the term ``after hours'' in 
paragraph 6.6(e)(3):

[[Page 58203]]

Several commentators requested that HRSA provide clarification or 
define the term ``after hours'' utilized in paragraph 6.6(e)(3), 
``Coverage-Related Activities.''
    (5) Set forth a presumption of FTCA coverage for all services 
within an approved scope of project:

Several commentators requested that HRSA assert a presumption of 
coverage for all providers' services and activities included within the 
health center's federally approved scope of project.

D. Agency Analysis and Decision

    (1) Clarify whether health centers that participate in health fairs 
are covered:

HRSA concurs with the comment and will add the phrase ``or participate 
in'' to paragraph 6.6(e)(1)(iii) of the final rule. The paragraph will 
therefore read ``Health Fairs: On behalf of the health center, health 
center staff conduct or participate in an event to attract community 
members for purposes of performing health assessments. Such events may 
be held in the health center, outside on its grounds, or elsewhere in 
the community.''
    (2) Clarify whether health centers that participate in immunization 
campaigns are covered:

HRSA concurs with the comment and will add the phrase ``or participate 
in'' to example 6.6(e)(1)(iv) of the final rule. The paragraph will 
therefore read, ``Immunization Campaign: On behalf of the health 
center, health center staff conduct or participate in an event to 
immunize individuals against infectious illnesses. Such events may be 
held in the health center, outside on its grounds, or elsewhere in the 
community.''
    (3) Add to the proposed new paragraph 6.6(e)(4), addressing 
individual emergency situations, the term ``urgent situations,'' and 
the phase, ``as determined by the health center provider at the scene 
of the incident:''

HRSA has considered the statutory language, its regulatory 
implementation, and the legislative history of the FSHCAA and is 
declining to adopt additional recommendations at this time, as these 
additions appear to substantially change the scope of the proposed 
regulation and introduce novel legal issues that were not intended by, 
and have not been fully addressed by, this rulemaking process.
    (4) Clarify, define, and/or delete the term ``after hours'' in 
paragraph 6.6(e)(3):

HRSA has considered the statutory language, its regulatory 
implementation, and the legislative history of the FSHCAA and is 
declining to adopt additional recommendations at this time, as these 
additions appear to substantially change the scope of the proposed 
regulation and introduce novel legal issues that were not intended by, 
and have not been fully addressed by, this rulemaking process. The 
original scope of this rule was to add an emergency situations example 
and to align the original immunization campaign example's language with 
HRSA's historical interpretation of that specific example. It is not 
within the scope of this rule, nor was it the intention of HRSA, to 
make substantial and material changes to other well-established 
examples that were congressionally approved. Moreover, it is not within 
the scope of this rule, nor was it HRSA's intention, to modify and 
expand the other examples beyond HRSA's historical interpretation of 
the established examples.
    (5) Set forth a presumption of FTCA coverage for all services 
within the federally approved scope of project:

HRSA declines to incorporate the suggested language, as the authorizing 
legislation, the FSHCAA, section 224(g)-(n) of the Public Health 
Service Act (42 U.S.C. 233(g)-(n)), does not expressly confer authority 
on the Secretary to extend such a presumption, and the addition of such 
a presumption introduces novel legal issues that were not intended by, 
and have not been fully addressed by, this rulemaking process.

Federalism

    HRSA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. HRSA has determined that the final 
rule does not contain policies that have substantial direct effects on 
the states, the relationship between the national government and the 
states, or the distribution of power and responsibilities among the 
various levels of government. Accordingly, HRSA has concluded that the 
final rule does not contain policies that have federalism implications 
as defined in the Executive Order and, consequently, a federalism 
summary impact statement is not required.

Other Impacts

    HRSA has examined the impacts of the final rule under Executive 
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the 
Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).
    Executive Order 12866 directs agencies to assess all costs and 
benefits of available regulatory alternatives and, when 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). This rule is 
not economically significant under section 3(f) of Executive Order 
12866 and is not being treated as a ``significant regulatory action'' 
under section 3(f). Accordingly, the rule has not been reviewed by the 
Office of Management and Budget.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because this final rule simply updates an existing 
regulation to add further details to the description of certain 
situations that are covered by the FTCA, and because such coverage is 
provided for under federal law, HRSA certifies that the rule will not 
have a significant economic impact on a substantial number of small 
entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any federal mandate that may result in the expenditure by 
state, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' HRSA does not expect this final rule to 
result in any one-year expenditure that would meet or exceed this 
amount.

Paperwork Reduction Act

    There are no new requirements for information collection associated 
with this amendment.

List of Subjects in 42 CFR Part 6

    Emergency medical services, Health care, Health facilities, Tort 
claims.

    Dated: September 12, 2013.
Mary K. Wakefield,
Administrator, Health Resources and Services Administration.
    Approved: September 16, 2013.
Kathleen Sebelius,
Secretary.

    In consideration of the foregoing, the Department Health and Human 
Services (HHS), Health Resources and Services Administration (HRSA) 
amends 42 CFR part 6 as follows:

PART 6--FEDERAL TORT CLAIMS ACT COVERAGE OF CERTAIN GRANTEES AND 
INDIVIDUALS

0
1. The authority citation for part 6 continues to read as follows:


[[Page 58204]]


    Authority: Sections 215 and 224 of the Public Health Service 
Act, 42 U.S.C. 216 and 233.


0
2. Amend Sec.  6.6 by adding paragraph (e)(4) to read as follows:


Sec.  6.6  Covered acts and omissions.

* * * * *
    (e) * * *
    (4) For the specific activities described in this paragraph (e)(4), 
when carried out by an entity (and its eligible personnel) that has 
been covered under paragraph (c) of this section, the Department has 
determined that coverage is provided under paragraph (d) of this 
section, without the need for specific application for an additional 
coverage determination under paragraph (d) of this section, if the 
activity or arrangement in question fits squarely within these 
descriptions; otherwise, the health center should seek a particularized 
determination of coverage.
    (i) Community-Wide Interventions. (A) School-Based Clinics: Health 
center staff provide primary and preventive health care services at a 
facility located in a school or on school grounds. The health center 
has a written affiliation agreement with the school.
    (B) School-Linked Clinics: Health center staff provide primary and 
preventive health care services, at a site not located on school 
grounds, to students of one or more schools. The health center has a 
written affiliation agreement with each school.
    (C) Health Fairs: On behalf of the health center, health center 
staff conduct or participate in an event to attract community members 
for purposes of performing health assessments. Such events may be held 
in the health center, outside on its grounds, or elsewhere in the 
community.
    (D) Immunization Campaigns: On behalf of the health center, health 
center staff conduct or participate in an event to immunize individuals 
against infectious illnesses. The event may be held at the health 
center, schools, or elsewhere in the community.
    (E) Migrant Camp Outreach: Health center staff travel to a migrant 
farmworker residence camp to conduct intake screening to determine 
those in need of clinic services (which may mean health care is 
provided at the time of such intake activity or during subsequent 
clinic staff visits to the camp).
    (F) Homeless Outreach: Health center staff travel to a shelter for 
homeless persons, or a street location where homeless persons 
congregate, to conduct intake screening to determine those in need of 
clinic services (which may mean health care is provided at the time of 
such intake activity or during subsequent clinic staff visits to that 
location).
    (ii) Hospital-Related Activities. Periodic hospital call or 
hospital emergency room coverage is required by the hospital as a 
condition for obtaining hospital admitting privileges. There must also 
be documentation for the particular health care provider that this 
coverage is a condition of employment at the health center.
    (iii) Coverage-Related Activities. As part of a health center's 
arrangement with local community providers for after-hours coverage of 
its patients, the health center's providers are required by their 
employment contract to provide periodic or occasional cross-coverage 
for patients of these providers.
    (iv) Coverage in Certain Individual Emergencies. A health center 
provider is providing or undertaking to provide covered services to a 
health center patient within the approved scope of project of the 
center, or to an individual who is not a patient of the health center 
under the conditions set forth in this rule, when the provider is then 
asked, called upon, or undertakes, at or near that location and as the 
result of a non-health center patient's emergency situation, to 
temporarily treat or assist in treating that non-health center patient. 
In addition to any other documentation required for the original 
services, the health center must have documentation (such as employee 
manual provisions, health center bylaws, or an employee contract) that 
the provision of individual emergency treatment, when the practitioner 
is already providing or undertaking to provide covered services, is a 
condition of employment at the health center.

[FR Doc. 2013-22993 Filed 9-20-13; 8:45 am]
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