On August 10, 2007, the Health Resources
and Services Administration (HRSA) made
the draft Program Information Notice
(PIN), “Specialty Services and
Health Centers’ Scope of Project,”
available for public comment on HRSA's
web site. The purpose of the PIN is
to describe the factors that will be
considered by HRSA when evaluating requests
from health centers seeking to add specialty
services to the scope of their Federal
section 330 project. Comments were
due to HRSA by October 19, 2007.
Over 65 comments were received from
20 organizations and/or individuals
regarding the draft PIN. After review
and careful consideration of all comments
received, HRSA 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 convey
the agency's response, including any
corresponding changes made to the PIN.
Where comments did not result in a revision
to the draft PIN, explanations are provided.
Issue:
Need for the Policy Guidance
Comments
Most commenters supported the publication
of this PIN, citing a need for clarity
regarding the addition of specialty
services to the Federal scope of project.
Commenters appreciated HRSA’s efforts
to create a “workable” policy and process
within an “adaptable framework.”
HRSA Response
HRSA recognizes that health centers
are a critical component of the Nation’s
health care safety net and must have
the ability to respond effectively to
needs in their communities. This PIN
was developed in response to requests
for clarity regarding the decision-making
process for evaluating requests to add
specialty services to the Federal scope
of project. The PIN reiterates HRSA’s
goal of supporting the extension of
needed health services to the underserved,
while ensuring that health centers continue
to (1) meet the current statutory, regulatory,
and policy requirements of the Health
Center Program and (2) comply with Department
of Health and Human Services (DHHS)
grants regulations and policy.
Issue: Application
of PIN to Services Already in Scope
(“Grandfathering”)
Comments
Most commenters asked for clarity regarding
the application of the PIN to health
centers that currently provide specialty
services. Specifically, commenters
expressed concern that retrospective
application of the PIN could negatively
impact many health centers by excluding
specialty services from the health center’s
Federal scope of project, resulting
in the discontinuation of specialty
services for health center patients.
As a result, commenters stated, there
could be negative health outcomes for
patients due to a break in the continuum
of care.
Other commenters asked for clarity
regarding the specific process and timeframe
for implementation of the PIN and reconciliation
of any inconsistencies between the new
policy and services currently within
grantees’ Federal section 330 scope
of project.
HRSA Response
In order to maintain consistent policy
requirements for all grantees, HRSA
will apply this PIN to all grantees.
In publishing this PIN, HRSA is providing
notice to grantees of the new policy.
As stated in the PIN, HRSA will provide
all grantees with an opportunity to
modify and/or update their scope of
project information to ensure that the
scope of project of every grantee is
consistent with the updated policies.
Therefore, if there are any discrepancies
between a health center’s current Federal
scope of project and the policy/criteria
outlined in the new PIN, HRSA will work
with the grantee to resolve the issues.
HRSA will not unilaterally delete any
services from a health center’s Federal
scope of project. The PIN will also
apply prospectively; therefore, health
centers will be given ample notice and
an opportunity to discuss with HRSA
any discrepancies between the set of
services currently offered by the health
center and the policy described in the
PIN.
Issue:
Use of Non-Federal Funds
Comments
Two organizations asked for information
regarding a health center’s purposeful
exclusion of a specialty service from
the Federal scope of project. One commenter
advocated for flexibility regarding
grantees’ ability to use non-Federal
funds. Another asked about the process
for demonstrating that specialty sites
operated outside of the Federal scope
of project are not being supported by
Federal funds.
HRSA Response
If a health center chooses to provide
services without using Health Center
Program funds and other funds (such
as program income) included as part
of the total project budget, it may
do so as a separate line of business.
Section III (particularly page 3) of
PIN 2008-01, “Defining
Scope of Project and Policy for Requesting
Changes,” provides further information
on health center activities that are
not part of a health center’s Federal
scope of project.
Issue:
Definition of “Primary Health Care Services”
Comments
A number of commenters suggested edits
to the PIN’s definition of “primary
health care services” (see section IV.E
of the PIN). Specific recommendations
included: adding optometric care to
the definition of primary care; adding
Adult Day Health Care (ADHC) to the
definition of primary health care; and
deleting psychiatric services from the
definition of primary health care.
Commenters also asked for a specific
list of professionals considered “primary
health care clinicians” and a specific
list of professionals considered “specialists.”
HRSA Response
The definition of “primary health care,”
for purposes of this PIN, is based on
the definition of “required primary
health services” in the Health Center
Program’s authorizing statute. (See
section 330(b)(1) of the Public Health
Service Act.) Optometry (with the exception
of pediatric eye screenings) and ADHC
are not included within section 330’s
definition of “required primary health
services.” However, this does not mean
a health center cannot submit a request
to add these services to its Federal
scope of project. Although we did not
change the PIN based on the comments
above, this PIN does not prevent the
inclusion of optometry or ADHC services
from the Federal scope of project.
With regard to psychiatry services,
the commenter stated: “professional
training and health care planning methods
designate psychiatry as a specialty
service.” As such, the commenter recommended
that psychiatry be eliminated from the
primary care definition, and added as
an example of an approvable specialty
service in section VI.B of the PIN.
HRSA accepts this recommendation and
has changed the PIN accordingly.
The PIN does not include an exhaustive
list of professionals considered primary
health care clinicians versus specialists.
Again, the definitions are intended
to be broad, and are based on the relevant
statute.
Issue:
Definition of “Specialty Services” and
“Specialists”
Comments
A number of commenters suggested changes
to the PIN’s definitions of “specialty
services” (see section IV.F of the PIN)
and “specialist” (section IV.G. of the
PIN).
Specific recommendations for the specialty
service definition included: (1) specifying
that specialists may perform both diagnostic
and treatment procedures; (2) clarifying
whether surgery in a hospital or ambulatory
surgical center is a specialty service
eligible for inclusion within the Federal
scope of project; and (3) defining specialty
services in the context of temporary
versus permanent sites.
With regard to the definition of “specialist,”
some organizations suggested that the
definition of a “specialist” be revised
to ensure consistency with clinical
usage. Others suggested that the definition
reference appropriate licensing and
credentialing of the specialist.
HRSA Response
As with the definition of “primary health
care,” HRSA based the definition of
“specialty services” on the language
in the Health Center Program’s authorizing
statute. (See the definition of “additional
health services” in section 330(b)(2)
of the Public Health Service Act.)
After consideration, HRSA has amended
the final PIN to include a statement
that specialty services may include
treatment procedures as well as diagnostic/screening
procedures.
The definition in the Health Center
Program’s authorizing statute includes
a list of examples, and a similar list
is provided in the PIN. Although the
PIN does not specifically mention surgery,
this does not preclude a health center
from requesting a change in scope to
add surgery to its Federal scope of
project. Whether or not such a request
is approved depends upon the evaluation
of all criteria described in this PIN.
The inclusion of temporary seasonal
service sites, intermittent sites, and
other irregularly-conducted activities
within the Federal scope of project
is addressed in PIN 2008-01 (see section
III(B)(1)). To address the commenter’s
suggestion, we have added a reference
to section III.B. of PIN 2008-01 (“Service
Sites”) at the end of section IV.D.
of this PIN. Also note that the policy
described in this PIN does not preclude
a health center from applying for an
extension of its Federal scope of project
to include specialty services at, for
example, a seasonal location.
Issue:
Examples of services that complement
required primary health care services
Comments
A number of commenters suggested that
section VI.B. of the PIN be revised
to include additional examples of specialty
services that would be eligible for
inclusion within the Federal scope of
project under the criteria described
in the PIN. A few commenters asked
that the examples be more “clinically-focused.”
Commenters also asked that HRSA develop
examples pertaining to the following
services:
- Dentistry;
- Gastroenterology;
- Ophthalmology; and
- Otolaryngology (ENT).
HRSA Response
The list of examples provided in the
PIN is not exhaustive. The final PIN
includes additional examples per the
commenters’ suggestions, but it is not
practical to develop a comprehensive
list of all potentially approvable specialty
services, due to the wide variations
in circumstances among individual health
centers.
Issue:
Service Location
Comments
A few commenters suggested modifications
to section VI.D. of the PIN (“Location
of the Service”), and asked that section
VI.D. be expanded to reference other
types of sites in addition to those
specified in the PIN. Other types of
sites mentioned by commenters included
intermittent sites and sites that do
not meet the definition of a “service
site.”
HRSA Response
HRSA has expanded the section to reference
other types of sites that may be within
the Federal scope of project.
Issue:
FTCA coverage
Comments
One commenter suggested modifying the
PIN to clarify that, for purposes of
FTCA coverage, the HRSA-approved scope
determination will be “recognized and
binding.” The commenter also asked
that the PIN be revised to include additional
information regarding malpractice insurance
for independent contractors.
HRSA Response
The PIN includes information regarding
FTCA coverage and citations for further
information. Because issues of coverage
can be complicated and affected by individual
health center circumstances, HRSA has
not included additional language regarding
binding determinations. However, language
has been added regarding private malpractice
insurance for independent contractors.
Issue:
Urban/Rural Impact
Comments
One organization suggested that urban
grantees would “benefit disproportionately”
from the policy, stating that (1) “few
specialists choose to practice in rural
areas,” and (2) rural patients, including
farmworkers, face barriers imposed by
distance and transportation costs.
HRSA Response
The policy described in the PIN is intended
to be flexible enough to allow grantees
to demonstrate all factors contributing
to the community’s need for the specialty
services. In the case of a health center
located in a rural area, transportation
barriers and costs may be a primary
reason for the community need, and these
barriers should be presented in the
change in scope request. The new policy
does not limit the type of information
that health centers may provide to demonstrate
need. In other words, rural and urban
grantees have an equal opportunity to
describe the needs of their respective
target populations.
Issue:
Emergency Room Services
Comments
One organization suggested that the
PIN include more information regarding
emergency room (ER) services and asked
whether ER services are eligible for
inclusion within a health center’s Federal
scope of project.
HRSA Response
“Emergency medical services” are among
the statutorily required primary health
services. However, health centers are
not expected to operate emergency rooms.
Whether ER services are appropriate
for inclusion within the Federal scope
of project depends upon the factors
described in this PIN.