[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:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
E-mail: [email protected]. Include ``RIN 0906-AA77'' in
the subject line of the message.
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