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.