On May 8, 1995, the Department of Health and Human Services,
with the concurrence of the Department of Justice, published
final regulations for the Federally Supported Health Centers
Assistance Act of 1992 (Attachment A). The final rule sets
forth information whereby an entity or an individual can
determine when, and the extent to which, it can reasonably
expect to be protected under the Act.
This Bureau of Primary Health Care (BPHC) Policy Information
Notice (PIN) updates BPHC PINs 93-07, issued April 27, 1993,
Policies and Procedures for Federal Tort Claims Act Coverage
Pursuant to the Federally Supported Health Centers
Assistance Act of 1992 (Pub.L. 102-501) and 93-17, issued
July 2, 1993, Financial Issues surrounding Federal Tort
Claims Act Medical Liability Coverage for Section 329, 330,
340, and 340A Deemed Centers.
The Federally Supported Health Centers Assistance Act of 1992 (Pub.L. 102-501) amends Section 224(a) of the Public Health Service (PHS) Act (42 U.S.C. 233) to extend eligibility for malpractice liability protection under the Federal Tort Claims Act (FTCA) to public or private, nonprofit entities receiving Federal funds pursuant to Section 329, 330, 340, or 340A of the PHS Act, as well as their officers, employees, and certain contractors.
Section 6.6 of the final regulations elaborates on the scope
of the statutory protection for deemed entities and
individuals. Basically, only acts or omissions within the
scope of the entity's approved Federal project and the
individual's scope of employment (or contract for services,
in the case of covered contractors) are covered. Thus, the
rule makes clear that any "moonlighting" activities of
health care practitioners at covered entities are not
covered.
Furthermore, Section 6.6(d) and the attached Federal
Register Notice published makes clear that certain
activities involving non-patients of the deemed entity are
coverable under FTCA (Attachment B).
If the covered entity is unsure whether its particular
arrangement falls within the scope of the examples, it may
apply to the Director, BPHC for a particularized
determination as to that arrangement. Entities should be
painstakingly exact in this regard. If any element of the
activity or arrangement in question does not fit squarely
into the examples a particularized determination on coverage
should be sought. As to situations that may fall within the
scope of 6.6(d), but are not described in the examples,
covered entities are expected to apply for particularized
determinations.
Acceptable licensure or certification are those conferred by
State entities or nationally recognized professional
credentialing organizations.
A subrecipient is defined as an entity which receives a
contract from a deemed entity to provide a full range of
health services on behalf of the deemed entity and only for
those services carried out under the scope of the approved
Federal project. Consequently, subrecipients are
organizations and not individual contractors. Individual
contractors must meet the statutory requirements for
coverage as outlined in BPHC PIN 93-7, issued April 27,
1993.
Subrecipients must also meet the same deeming requirements
for FTCA coverage eligibility as the grantee as specified in
BPHC PIN 93-7 (e.g., malpractice risk reduction policies,
implementation of a health care practitioner credentialing
system, etc.). This can be accomplished either separately
or by participating collaboratively with the deemed entity.
Clarification provided by Section 6.6 of the regulations of
the acts coverable under the FTCA will likely have the
effect of providing more comprehensive malpractice liability
protection for deemed centers for activities within the
scope of their approved Federal project. Due to the timing
of the publication of the regulations and the possiblesunset of the program on December 31, 1995, it may not be
cost-effective for a deemed health center to drop an
existing private comprehensive or gap malpractice insurance
policy due to factors such as the cost for tail insurance,
termination penalty on policy, or policies prepaid beyond
December 31, 1995. However, in light of the issued
regulations, deemed centers with gap policies may be able to
terminate them if that coverage was applicable to the
examples cited in the rule.
To further evaluate the financial implications of the
program, grantees are required to submit the malpractice
cost worksheet (Attachment C) and forward it to the Regional
Grants Management Officer by September 30, 1995.
Deemed centers that experience a net savings in malpractice
insurance costs may use the savings within the scope of the
approved Section 329, 330, 340, or 340A Federal project,
provided that a revised program budget is submitted to the
appropriate Regional Grants Management Office for approval.
These savings may be used to increase the number of users,
increase the range of services provided (including case
management and activities or programs aimed at reducing language and cultural barriers to care), or to implement
administrative improvements (including clinical quality
improvements/risk management activities).
In the event that a PHS administrative claim or suit in
State court is filed against the health center or staff the
following information should be transmitted to the Chief,
Litigation Branch, Office of the General Counsel, Business
and Law Division, Department of Health and Human Services,
330 Independence Avenue, S.W., Cohen Building, Room 5362,
Washington, D.C. 20201:
- A copy of the entity's deeming letter;
- Evidence of the defendant's employment status with the
health center. In the event the defendant is a
contractor at the time of the alleged incident, provide
evidence that the contractor worked an average of 32
1/2 hours per week or was providing obstetrical
services;
- Evidence that the defendant was licensed or certified
at the time of the incident;
- . If the act or omission occurred outside the health
center's facilities, provide the name and address of
the outside facility and information as to the nature
of the affiliation between the outside facility and the
health center and the defendant;
- Evidence as to the financial arrangements with the
defendant regarding billing for the medical/dental
services at issue. Specifically, verify that the
defendant was not billing privately for the services or
was not being paid or compensated above his or her
employment/contract wages for the services;
- A copy of all medical records from the health center
and any private facility that might be involved; and
- A copy of any and all insurance policies providing
malpractice insurance to the health center and the
defendant, whether or not the health center and
defendant (or insurer) believe the policies do not
provide coverage in the situation
The BPHC in collaboration with the PHS Claims Office has
established a data base with the pertinent information on
each malpractice claim filed.
Malpractice claims filed with the PHS are reviewed by the
PHS Quality Review Panel for a recommendation on the merits
of the claim. The findings of the panel including quality
assurance issues, if appropriate, will be transmitted to the appropriate regional office for use in dialogue with the
health center regarding the claim. Furthermore, the final
action by the Department of Health and Human Services and/or
Department of Justice will also be transmitted to each
regional office when available.
Billing Code: 4160-15
DEPARTMENT OF HEALTH AND HUMAN SERVICES
HEALTH RESOURCES AND SERVICES ADMINISTRATION
NOTICE REGARDING THE FEDERALLY SUPPORTED
HEALTH CENTERS ASSISTANCE ACT OF 1992
AGENCY: Health Resources and Services Administration
ACTION: Notice
SUMMARY: On May 8, 1995, the Secretary of Health and Human
Services published a final rule implementing certain provisions
of the Federally Supported Health Centers Assistance Act of 1992
(the Act). The Act provides for liability protection for certain
grantees of the Public Health Service and for certain individuals
associated with these grantees. The Health Resources and
Services Administration is the agency within the Department
responsible for administering certain aspects of the Act. This
notice provides further guidance regarding the final rule.
FOR FURTHER INFORMATION CONTACT: Division of Community and Migrant Health
Bureau of Primary Health Care
Health Resources and Services Administration
4350 East West Highway
Bethesda, Maryland 20814
Phone: (301) 594-4300.
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 civil action or proceeding. The Federally Supported
Health Centers Assistance Act of 1992 (Public Law 102-501)
provides that, subject to its provisions, certain entities and
officers, employees and contractors of entities shall be deemed
to be employees of the PHS within exclusive remedy provision of
section 224
(a).
The final rule implementing Public Law 102-501 was published
in the Federal Register (60 FR 22530) on May 8, 1995, and adds a
new Part 6 to 42 CFR Chapter 1. Part 6 describes the eligible
entities and the covered individuals who are within the scope of the FTCA protection afforded by the Act.
Section 6.6 of the final rule describes the acts and
omissions that are covered by the Act. Paragraph (d) of that
section states that only acts and omissions related to the grantsupported
activity of covered entities are covered. That
paragraph goes on to provide that:
Acts and omissions related to services provided to
individuals who are not patients of a covered entity will be
covered only if the Secretary determines that
- The provision of the services to such individuals
benefits patients of the entity and general populations
that could be served by the entity through communitywide
intervention efforts within the communities served
by such entity;
- The provision of the services to such individuals
facilitates the provision of services to patients of
the entity; or
- Such services are otherwise required to be
provided to such individuals under an employment
contract or similar arrangement between the entity and
the covered individual.
Paragraph (e) of 6.6 provides examples of situations within
the scope of paragraph (d). Questions have been raised, however,
about the specific situations encompassed by 6.6(d) and about the
process for the Secretary to make the determinations provided by
that paragraph. The purpose of this notice is to address those
questions.
We have decided that it would be impractical and burdensome
to require a separate application and determination of coverage
for the situations described in the examples set forth in 6.6(e).
Accordingly, for the specific cases described in those examples,
and discussed further below, the Department hereby determines
that coverage is provided under 6.6(d), without the need for
specific application. (This determination assumes, of course,
that other requirements of coverage have been met, such as a
determination that the entity is a covered entity and a
determination that the individual is a covered individual.
Furthermore, we reiterate the statement in the preamble to the
final rule that acts or omissions by individuals that are not
within the scope of employment, e.g., moonlighting activities,
are not covered.)
While the situations described below have hereby been
determined to be within the scope of 6.6(d), covered entities may
apply for specific determinations of coverage under that section.
If, for example, the covered entity is unsure whether its
particular arrangement falls within the scope of example 2, it
may apply for a particularized determination as to that
arrangement. Entities should be painstakingly exact in this
regard. If any element of the activity or arrangement in
question does not fit squarely into the examples below, a
particularized determination on coverage should be sought. As to
situations that may fall within the scope of 6.6(d), but are not
described in the three examples, covered entities are expected to
apply for particularized determinations.
Example I. Community-Wide Interventions
- 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.
- 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.
- 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.
- Immunization Campaign: Health center staff
conduct an event to immunize children against
infectious childhood illnesses. The event may be
held at the health center, schools, or elsewhere
in the community.
- 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).
- 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).
Example II. Hospital-Related Activities
Periodic hospital call or hospital emergency room
coverage, as 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.
Example 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.
Issued September 19 , 1995 - Last reviewed November 22, 2006 |