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On March 15, 2007, the Health Resources
and Services Administration (HRSA) made
the draft Program Information Notice (PIN),
“Federal Tort Claims Act Coverage
for Health Center Program Grantees Responding
to Emergencies,” available for public
comment on HRSA's public Web site. The
purpose of the PIN is to describe and
clarify the circumstances under which
FTCA-deemed Health Center Program grantees
are covered under the FTCA as they respond
to emergencies. Comments were to be provided
to HRSA by May 31, 2007.
Comments were received from 14 organizations
and/or individuals regarding the draft
PIN. After review and careful consideration
of all comments received, HRSA has amended
the PIN to incorporate certain recommendations
from the public. The final PIN reflects
these changes.
The purpose of this document is to summarize
the major comments received and describe
the agency's response, including any corresponding
changes made to the PIN. Where comments
did not result in a revision to the PIN,
explanations are provided.
Issue: Flexibility
of Policy
Comments:
Some commenters were concerned that the
draft PIN did not reflect “on-the-ground
demands” of emergencies. Specifically,
one organization stated that HRSA “stop[ped]
well short of employing the broad discretion
permitted by the FTCA and Section 330
of the PHS Act (and related policy) to
authorize the greatest range of aid and
support that health centers are able to
offer in response to an emergency or disaster.”
HRSA Response:
HRSA recognizes that health centers are
a critical component of the Nation’s
emergency medical response system. The
PIN was developed with the goal of allowing
health centers the flexibility to effectively
respond during emergencies, while creating
a policy that is consistent with the current
Health Center Program’s authorizing
statute and implementing regulations and
policy, and consistent with the authorizing
statute for the Health Center FTCA Program
and its implementing regulations.
With regard to the PIN’s flexibility,
the term “emergency” is defined
quite broadly in the PIN, and the PIN
includes a provision that allows for case-by-case
exceptions so that a situation may be
deemed an “emergency” even
where there is no accompanying official
declaration. The PIN also presents two
alternatives to the formal change in scope
request process, providing health centers
with a more streamlined and rapid process
for adding temporary sites to the scope
of project during and after an emergency.
These provisions of the PIN were developed
with the intent to provide health centers
with maximum flexibility to respond during
emergencies, within the permissible scope
of relevant law and regulations.
Issue: Involvement
of Non-Affected Health Centers
Comments:
Many organizations and individuals expressed
concern that the draft PIN did not address
circumstances in which health center staff
from health centers located in areas not
adjacent to the affected health center
travel long distances to assist with the
provision of health care services during
national and regional disasters and emergencies.
Specifically, one organization stated
that the PIN should “be amended
to allow for a deemed health center in
another part of the country, after receiving
a request from a legitimate and legal
entity including the Public Health Service,
to relocate temporarily to a neighboring
or distant state to provide emergent relief
through the use of mobile vans or loaned
staff.”
Another commenter stated: “It is
reasonable to expect that during a significant
emergency situation, if the health centers
and the infrastructure of the area are
destroyed, health center staff may be
missing or worse dead. If a health center
from another state has the ability and
resources to temporarily establish a clinic
site to quickly provide necessary and
immediate services to the disaster victims,
the temporary site should qualify for
FTCA coverage.”
Similarly, another organization expressed
its belief that the law and regulations
allowed for the “extension of FTCA
coverage to all health centers (impacted
and non-impacted) and their health care
professionals offering temporary aid to
communities affected by an emergency or
disaster through the provision of health
services, regardless of whether: 1) the
emergency occurred within or outside of
the health center’s service area;
2) the services are provided to residents
of the health center’s current service
area or to existing health center patients;
or 3) the service is within the health
center’s current approved scope
(provided that the individual provider
has appropriate certification/licensure
to furnish the service and the service
is not prohibited under Section 330).”
Some comments included suggestions to
revise the PIN to explicitly permit health
centers, in response to a Federal national
emergency, to redefine their service areas
to include services outside the State
to allow “communities to come to
the aid of other communities experiencing
disaster - if they are able to do so without
unreasonably hindering health care access
in their non-emergency service areas.”
Specifically, there was a request that
the draft PIN be rewritten “to allow
health center program grantees from around
the country to have FTCA coverage extended
to them on a temporary basis during a
declared emergency.”
HRSA Response:
One of the goals of this PIN is to provide
clarification regarding the geographic
scope of FTCA coverage. Frequently Asked
Question #2 in Section VI. of the PIN
addresses the issue of FTCA coverage when
a health care provider crosses State lines.
Also, the final PIN includes a new Section
IV.C., which explains that, in emergency
situations, health centers that are not
impacted by the emergency may (1) assist
at temporary sites within the same service
area and within neighboring counties,
parishes, or political subdivisions or
(2) operate temporary sites within the
service area and within neighboring counties,
parishes, or political subdivisions by
including the temporary locations within
the scope of project using the process
described in Section IV.A. [of the PIN].”
The final PIN also clarifies that the
emergency change-in-scope request processes
described in the PIN are not applicable
to situations where employees of non-impacted
health centers seek FTCA coverage to provide
care during emergencies outside their
service area and beyond neighboring counties,
parishes, or political subdivisions.
Issue: Grantee
Contact with HRSA & Timeframe for
Decisions
Comment:
Commenters suggested that the PIN include
clarification regarding: the grantee’s
point-of-contact at HRSA (including a
back-up point-of-contact if the project
officer is unreachable); the information
HRSA staff will require from the health
center, and HRSA’s point-of-contact
at the health center.
HRSA Response:
HRSA agrees with the recommendation, and
has revised the PIN to include HRSA/BPHC’s
main number and the FTCA Help Line in
case the project officer is not available.
Sections IV.A and IV.B have also been
revised to specify the kind of information
that the health center should be prepared
to provide. Regarding HRSA’s point-of-contact
at the health center, the health center
has the discretion to identify the person
it believes is most appropriate.
Comment:
One commenter suggested that the process
described in Section IV.B. be changed
to mirror the 15 day timeframe described
in Section IV.A (health centers must submit
information no later than 15 days after
initiating emergency response activities).
HRSA Response: The process
described in Section IV. B. should be
used when a health center opens a temporary
site outside its service area and beyond
neighboring counties, parishes, or other
political subdivisions adjacent to the
service area. In such a scenario, HRSA,
on behalf of the Secretary, must pre-approve
the change in scope. However, when the
health center remains inside the service
area and within the boundaries described
above, HRSA will grant a temporary expansion
of the scope of project to include emergency
response activities if all conditions
in Section IV.A. are met. The health center
does not need to request pre-approval,
but it does need to submit, within 15
days, the information listed in section
IV.A. of the PIN. Regarding the 15-day
period, HRSA’s expectation is that
health centers will make good-faith determinations
that all criteria are met, and contact
their project officer as soon as possible
to provide more detailed information.
If the health center follows the process
described in IV.A., FTCA coverage will
be effective beginning with the initiation
of emergency response activities.
Comment: One commenter,
referring to the process described in
Section IV.B. of the PIN, stated that
“it is imperative that this process
be expedient,” and others stated
that a wait of 48 hours for malpractice
coverage determinations in emergency situations
is too long. Commenters believed that
“health centers must be allowed
to react immediately to emergency situations
and provide care to emergency victims
without fear of a gap in coverage.”
HRSA Response: Our goal
will be to provide the health center with
a decision regarding the change in scope
request as soon as possible, ideally within
a few hours, not 48 hours. However, requests
to provide services outside the community
must be pre-approved. We expect that throughout
this process, the project officer or other
HRSA representative will be keeping the
health center updated regarding the status
of the review.
Issue: Health
Center Staff and Personnel
Comment:
We received a question regarding the applicability
of the PIN to FTCA coverage in Locums
Tenens situations.
HRSA Response:
Please see Section IV. of PIN 99-08 (Health
Centers and the Federal Tort Claims Act”),
which addresses “covered individuals.”
Issue: Definition
of “Emergency”
Comments:
One organization recommended that we provide
more information and general guidelines
regarding the criteria that would be applied
when determining whether circumstances
specific to the health center constitute
an “emergency” for purposes
of FTCA coverage (see second paragraph,
Section III of the draft PIN).
Another organization suggested that we
clarify that the PIN addresses the delivery
of FQHC services in an emergency or disaster
(rather than “emergency services,”
which are already required under section
330 of the PHS Act).
One commenter requested that we use the
phrase “target population and/or
community at large” throughout the
PIN or replace it with “affected
communities.”
HRSA Response:
When developing the definition of “emergency”
we wanted to include additional flexibility
to include health center-specific emergencies,
e.g., a fire. See below for additional
examples of such health-center specific
emergencies. We have also deleted the
phrase, “but the health center is
unable to operate.” We have done
this to allow the health center to respond
in situations of emergency that may not
be widespread, and do not directly affect
the health center. An example of this
type of emergency is a bus accident or
car crash that occurs near the health
center.
Regarding the “emergency services”
suggestion, we have changed the PIN to
include the reference to “FQHC services
in an emergency or disaster.”
Regarding the suggestion of a word change
to “affected communities,”
we did not insert the term “affected
communities” because the term “target
population” is more consistent with
terminology used to describe a health
center’s scope of project. We also
kept the term “community at large”
to convey that the emergency may impact
not just the health center’s target
population, but the entire community.
Issue: General
Comments on Section IV (“Scope of
Project & FTCA Coverage”)
Comment: Several commenters
were concerned regarding the requirements
listed in Sections IV.A. and IV.B. Commenters
suggested that the PIN be modified by:
- Deleting condition in Section IV.A.
requiring that the temporary location
be located in the health center’s
service area or an adjacent/neighboring
county/parish/political subdivision;
and
- Deleting the condition in Section
IV.B. requiring the health center to
serve its original target population.
Others recommend that Sections IV. A
and IV. B be combined, arguing that “there
is no reason” to make a distinction
between “within the service area”
and “outside the service area.”
HRSA Response:
The PIN makes a distinction between “inside
the service area” and “outside
the service area” because prior
approval is required when extending FTCA
coverage to temporary sites established
in an area outside the health center’s
regular service area. This distinction
is based on the agency’s determination
that extensions of a health center’s
service area to include locations beyond
areas immediately adjacent to the service
area constitutes a significant change
to the scope of project, and therefore
requires prior approval.
Comment: One commenter
suggested that the PIN extend FTCA coverage
for services that may not be included
in a health center’s existing scope
of project, but could be granted in-scope
status temporarily. The rationale was
that “certain providers may possess
critical skills needed to provide services
that are outside the health center’s
current scope (i.e. furnished by referral
to another provider rather than directly
by the HC) but are nonetheless needed
during a crisis.”
HRSA Response: This
issue is still being evaluated by HRSA,
and may be addressed in final versions
of change-in-scope PINs recently issued
in draft.
Issue: FTCA
Coverage for Volunteers
Comment:
One organization asked whether providers
would be covered under the FTCA if, in
an emergency, those providers went outside
of the service area to provide primary
care medical services in a major emergency.
The specific question was, even if the
providers volunteered in their individual
capacity to respond to the major emergency,
would the services be covered if the Chief
Executive Officer and/or the Board of
Directors approved the service of the
providers on behalf of the health center,
prior to their deployment to the emergency
area.
HRSA Response: As stated
in section V. of the PIN, providers volunteering
in their individual capacity are not covered
under the Health Center FTCA Program.
Comment:
Two commenters asked that the draft PIN
be revised to include additional information
on medical malpractice coverage options
for providers volunteering in response
to an emergency. One commenter noted that
this information is included in FAQ #10
of the draft PIN, but recommended that
it should also be included elsewhere in
the PIN.
HRSA Response:
We concur with this recommendation. Therefore,
we amended Section V. of the PIN to include
references to alternative medical malpractice
coverage options.
Issue: Following
the Target Population
Comment:
Pertaining to Item 1 under Section IV.
B., several commenters stated that disaster
victims do not migrate as a group, and
it would therefore be unreasonable to
expect the health center to be able to
serve the original target population through
one temporary site. In the same regard,
it is unreasonable to expect the health
center to establish enough sites to cover
all of the areas where the original target
population migrated. Some suggested the
deletion of this condition entirely. One
commenter suggested a wording change –
from “target population” to
“affected communities.” An
alternative to the first criteria was
suggested: rather than demonstrating that
“the purpose of the temporary site
is to provide services to its original
target population,” the health center
should demonstrate that services are being
provided to a medically underserved community
where significant numbers of displaced
disaster victims are located.”
Similarly, some organizations expressed
concern that the PIN did not incorporate
more flexibility for Health Centers to
establish temporary sites outside of their
service area and to provide for a variety
of different disasters/situations.
One commenter referenced Title III of
the “The Pandemic and All-Hazards
Preparedness Act” (S. 3678), which
addresses community response to emergencies.
The commenter stated that “it would
be very difficult in a crises to determine
target populations and, in reality, the
new underserved population could quickly
and significantly expand.”
HRSA Response:
We recognize that although there may be
concentrated areas of individuals displaced
by a disaster (e.g. Houston, in the case
of Hurricane Katrina), the migration of
disaster victims is often widespread.
We also recognize that it would be difficult
to limit the provision of services only
to previously registered patients or patients
who have traveled from the health center’s
community. Therefore, we have modified
the first condition of Section IV. B.
to state that health centers must demonstrate
that the purpose of the scope change should
be “to provide services primarily
to the health center’s target population
and to other medically underserved populations
that may have been displaced by the disaster.”
Issue: Intermittent
Federal Employees
Comment:
One organization asked for more information
on deployment as an intermittent Federal
employee, which is mentioned in the answer
to FAQ number 10.
HRSA Response: In the
aftermath of Hurricane Katrina, the Department
of Health and Human Services’ Office
of Public Health Emergency Preparedness
sought civilian relief workers to assist
in areas devastated by Hurricane Katrina.
Certain workers providing medical care
in the impacted areas were sworn in as
temporary, Federal employees serving under
a FEMA Mission Assignment. As temporary
Federal employees, these providers qualified
for FTCA coverage under the general FTCA
authority. Although HHS is no longer deploying
civilian relief workers under the Hurricane
Katrina FEMA Mission Assignment, it is
possible that in a future Federally-declared
emergency, FEMA will again provide an
opportunity for civilians to volunteer
and serve as intermittent Federal employees.
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