[Federal Register Volume 76, Number 39 (Monday, February 28, 2011)]
[Proposed Rules]
[Pages 10825-10827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-3439]


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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, HHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Federally Supported Health Centers Assistance Act of 1992, 
as amended in 1995 (FSHCAA), provides for liability protection for

[[Page 10826]]

certain grantees of the Public Health Service and for certain 
individuals associated with these grantees. The Health Resources and 
Services Administration (HRSA) is the operating division within the 
Department responsible for administering certain aspects of FSHCAA. 
HRSA proposes replacing the current regulations 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 Sept. 25, 1995 Federal Register. In 
addition, HRSA proposes adding an example of services covered under the 
FTCA involving individual emergency care provided to a non-health 
center patient and updating the September 1995 Notice immunization 
example to include events to immunize individuals against infectious 
illnesses. When finalized, the amended regulation will supersede the 
September 1995 Notice.

DATES: Written comments must be received on or before April 29, 2011. 
Subject to consideration of the comments submitted, the Department 
intends to publish final regulations.

ADDRESSES: You may submit comments, identified by the Regulatory 
Information Number (RIN) 0906-AA77, by any of the following methods:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
    <bullet> E-mail: <a href="/cdn-cgi/l/email-protection#400f1104032f2d2d252e343300283233216e272f36"><span class="__cf_email__" data-cfemail="014e5045426e6c6c646f757241697372602f666e77">[email protected]</span></a>. Include ``RIN 0906-AA77'' in 
the subject line of the message.
    <bullet> Mail: Correspondence should be marked ``Health Center FTCA 
Program Regulation Comments'' and mailed to: 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 15C-26, Rockville, Maryland 20857.
    Instructions: All submissions received must include the agency name 
and RIN for this rulemaking. All comments received will be available 
for public inspection and copying without charge at Parklawn Building, 
5600 Fishers Lane, Room 15C-26, Rockville, Maryland 20857, weekdays 
(Federal holidays excepted) between the hours of 8:30 a.m. and 5 p.m.

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 15C-26, Rockville, Maryland 20857, Phone: (301) 594-
0818.

SUPPLEMENTARY INFORMATION: Section 224(a) of the Public Health Service 
(PHS) Act (42 U.S.C. 233(a)) provides that the remedy against the 
United States provided under the Federal Tort Claims Act (FTCA) 
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 (Pub. L. 102-501), as 
amended in 1995 (FSHCAA), 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, and employees, and 
certain contractors of these entities, shall be deemed for the purposes 
of medical malpractice liability to be employees of the PHS within the 
exclusive remedy provision of section 224(a) of the PHS Act.
    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 1, 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). Subsection 6.6(d) restates 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.
    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, the Department has set forth its determination that 
coverage is provided 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 that the 
acts or omissions by those individuals occur within the scope of 
employment.
    HRSA proposes including the key text and examples of the September 
1995 Notice in 42 CFR 6.6(e), replacing the current regulatory text at 
42 CFR 6.6(e). HRSA also proposes updating the ``Immunization 
Campaign'' example to clarify that this covered situation includes 
events to immunize individuals against infectious illnesses and does 
not limit coverage to only childhood vaccinations. In addition, HRSA 
proposes adding the following additional new example as subsection 
6.6(e)(4) to set forth its determination of FTCA coverage for services 
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.
    We will consider comments on this proposed rule that are received 
within 60 days of publication of this notice in the Federal Register. 
After the comment period closes, we will publish a final rule in the 
Federal Register. The document will include a discussion of any 
comments we receive and any changes.

Federalism

    HRSA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. HRSA has determined that 
the proposed rule does not contain policies that 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. Accordingly, 
HRSA has concluded that the proposed 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 proposed 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

[[Page 10827]]

and safety, and other advantages; distributive impacts; and equity). 
HRSA believes that this proposed rule is not a significant regulatory 
action under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because this proposed 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 proposed rule 
to result in any one-year expenditure that would meet or exceed this 
amount.

Paperwork Reduction Act

    This rule does not contain any new information collection or 
recordkeeping requirements that fall under the purview of the Paperwork 
Reduction Act of 1995. The recordkeeping requirements contained in this 
rule are part of normal business practice and do not require the 
collection of new information or impose additional requirements beyond 
current routine practice.

List of Subjects in 42 CFR Part 6

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

    Dated: May 27, 2010.
Mary Wakefield,
Administrator, Health Resources and Services Administration.
    Approved: January 24, 2011.
Kathleen Sebelius,
Secretary.

    For the reasons stated in the preamble, we are proposing to amend 
42 CFR part 6 as follows:

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

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

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

    2. In Sec.  6.6, revise paragraph (e) to read as follows:


Sec.  6.6  Covered acts and omissions.

* * * * *
    (e) For the specific activities described in this paragraph, when 
carried out by an entity 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 a coverage determination under paragraph (d) of this 
section, if the activity or arrangement in question fits squarely 
within the examples of activities listed below; otherwise, the health 
center should seek a particularized determination of coverage under 
paragraph (d) of this section.
    (1) Community-Wide Interventions. (i) 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.
    (ii) 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.
    (iii) Health Fairs. Health center staff conduct 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.
    (iv) Immunization Campaigns. Health center staff conduct an event 
to immunize individuals against infectious illnesses. The event may be 
held at the health center, schools, or elsewhere in the community.
    (v) 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).
    (vi) 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).
    (2) 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.
    (3) 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.
    (4) 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. 2011-3439 Filed 2-25-11; 8:45 am]
BILLING CODE 4160-15-P


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