Comments on Draft and HRSA Response
On August 8 , 2007, HRSA made the draft Program Information Notice (PIN) Defining Scope of Project and Policy for Requesting Changes available on the Web for public comment. Comments were due to HRSA by October 19, 2007.
The purpose of the PIN is to
- define what constitutes the scope of project for health centers funded under section 330 of the Public Health Service Act,
- specify which types of changes in scope require prior approval and
- describe the process for health centers seeking to make changes in the approved scope of project.
More than 120 comments were received from 26 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 PIN, explanations are provided.
Issue:
Appropriateness of the Policy Guidance
Comments
Most commenters supported the publication of this PIN, stating the need for an updated policy for defining scope of project and the process by which health centers can determine when and how to request changes to their approved scopes. Commenters appreciated the balance between the need for a uniform policy and the ability of an individual health center to establish a scope of services and delivery model appropriate for its community.
HRSA Response
HRSA recognizes that health centers are a critical component of the Nation's health care safety net and in order to continue to provide services to the uninsured and underserved, policies must be updated to align with current health care trends and innovative delivery methods. Proper recording of scope of project is critical in the oversight and management of Health Center Program. The PIN was developed with the goal of providing health centers with a comprehensive policy for defining their scope of project and requesting changes to their approved scopes.
Issue:
General Clarifications/Updates, Consistency
Comments
A number of the comments suggested the use of common, consistent terminology and more detail in certain areas to provide greater clarity for grantees in understanding and recording scope of project.
HRSA Response
With regard to consistency within the PIN, the document has been reviewed and edited to ensure that the guidance provided to grantees is consistent throughout all sections of the document.
Issue: Expectation for Prior Approval
Comments
A number of commenters suggested that the policies and process outlined in the PIN will be unnecessarily burdensome for some grantees with many sites within the same community or limited geographic distance. In this context, the common concern amongst commenters is that very minor redeployments of grantee resources from site to site occurs relatively frequently throughout the year and should not be subjected to the prior authorization process. Many commenters requested greater flexibility in deploying resources as necessary without having to wait for a change in scope request to be reviewed and approved before making adjustments as the need to reallocate services across services is not always predictable.
A few commenters requested further clarification on the requirement for prior approval for changes in scope regarding the expansion or addition of space to an approved site (e.g., expanding within its suite or to another suite in the same building) or moving offices within the same building as an approved site.
In regard to relocations, several commenters suggested HRSA require prior notification with the assurance that the relocation would not diminish the health center's current level or quality of services provided to its existing target population rather than prior authorization. Additionally, some commenters requested that HRSA clarify in further detail the requirements of health centers that wish to relocate of service sites that may cause disputes between projects over service area.
HRSA Response
A goal of this PIN is to provide further clarification on the types of changes in scope that require prior approval. HRSA recognizes the challenges faced by many health centers in assuring resources are maximized to provide services to their target population. As a result, the PIN has been revised to provide more detailed explanation regarding the various types of sites and how a health center should record these sites.
The final PIN includes guidance for grantees seeking to add a new location that meets the definition of a service delivery site within the same building or complex/campus.
Issue: Process/EHB
Comments
A number of commenters suggested that HRSA provide more clarification on the timeline and method by which HRSA decisions will be communicated regarding approval/disapproval of change in scope requests. Several commenters also noted that it is not clear when a CIS application is regarded as “complete,” which represents the beginning point in time for the HRSA review process. Further, as the PIN indicates that it is HRSA's goal to communicate decisions on requests for change in scope within 30 days of receipt, several commenters requested explicit assurance that this turnaround timeframe from receipt of complete request be upheld.
HRSA Response
HRSA's goal is to respond to grantees within 30 days of receipt of a complete request to the Project Officer. Once fully implemented, only complete applications will be able to be submitted through the EHB system. The effective date of approval for change in scope request will be no earlier than the date of receipt of a complete request.
Issue: Other Settings/Other PINs
Comments
Most of the commenters stated that the PIN does not address institutional settings where health centers already have or are seeking to deliver care. Commenters suggested that HRSA clarify that non-health center facilities, such as nursing homes and residential treatment facilities, at which health center clinicians treat health center patients on a regularly scheduled basis under the operation and control of the health center can be included in the health center's scope of project, provided that the site satisfies the criteria necessary to be defined as a “service site.”
HRSA Response
This policy issue is still being evaluated by HRSA and will be addressed in PINs to be released in the near future.
Issue:
Effective Date of Approval/Appeals
Comments
A number of commenters requested that HRSA consider an appeals process for grantees which can be utilized after the final decision on a change in scope request is communicated but before a new request is submitted. While the PIN described a process by which health centers will be able to correct deficiencies identified prior to the final decision by HRSA, the PIN did not indicate if there would be an appeals process once the final decision is communicated to the health center.
Many commenters identified concern with the 120-day time period that has been established for a grantee to implement an approved change in scope request. While the 120 day time period may be appropriate in most circumstances (e.g., adding a new service), there are instances in which this limited time period will not permit a grantee to appropriately administer its activities. For example, if a health center is planning to perform capital improvements by constructing a building or entering into a long term lease in which there will be a "build out" or significant modifications to the space, the timeframe for completing the work will often exceed 120 days. In order to address these concerns, commenters suggested including language in the PIN that provides exceptions for these types of changes in scope or remove the 120-day limitation.
HRSA Response
While there is no formal opportunity for an appeal on a HRSA decision on a change in scope request, HRSA will provide grantees with opportunities to revise and amend their requests during the review process. If at the end of the review process, HRSA determines that a request is not approvable, the decision is final and the grantee would need to submit a new complete request for review by HRSA.
HRSA acknowledges that, in some instances, grantees encounter obstacles in implementing the requested change in scope within the 120-day timeframe. Therefore, grantees should carefully consider their ability to accomplish the requested change. In rare occurrences, the BPHC will consider, on a case by case basis, exceptions to the 120-day implementation requirement only if the grantee provides sufficient and compelling justification.
Issue:
Impact on Neighboring Health Centers
Comments
A few commenters noted that the PIN should formalize the process of not only requesting a scope change but also for allowing others, most likely affected neighboring projects, to provide their input prior to HRSA's decision. In addition, one commenter recommended health centers submit detailed evidence of need and a sustainability plan for any proposed change that may have a potential negative impact on neighboring health centers. Commenters further suggested that HRSA include special considerations for health centers serving only a special population, such as migrant and seasonal farmworkers, people experiencing homelessness or residents of public housing, in a community where there is also a section 330(e) grantee in that such a situation should not be considered a service area overlap requiring validation from the board of the community health center in order to make changes in their scope of project. A few commenters also suggested that it is unrealistic to expect a Board of Directors to provide a letter of support for another organization to enter the service area, even when there are obvious unmet health care needs in that community.
HRSA Response
Health centers should coordinate and collaborate with other local health services providers in the same or adjacent service areas serving underserved populations. Section 330 of the PHS Act specifically requires that applicants for health center funding have made “and will continue to make every reasonable effort to establish and maintain collaborative relationships with other health care providers in the catchment area of the center” (PHS Act section 330(k)(3)(B)). The goal of collaboration is to utilize the strengths of all involved organizations to best meet the overall health care needs of the area's underserved population.
Regarding the suggestion that health centers should not be expected to contact the Board of Directors of a neighboring health center when opening or relocating a site in their vicinity, collaboration is essential in maximizing limited resources and access to care for underserved populations, and HRSA will continue to expect health centers to collaborate with other area providers and to provide an indication of support from other area health centers as part of a change in scope request. For further information on service areas, grantees should refer to PIN 2007-09: Service Area Overlap: Policy and Process.
Issue: Migrant Voucher Sites
Comments
A number of commenters indicated that additional clarification was needed around “Intermittent or Voucher Sites.” Commenters suggested that the definition of a seasonal site should be amended to include these site types. Several commenters recommended that a credentialed physician's office that is located in a community that serves migrant and seasonal farmworkers and has scheduled office hours specifically for seeing migrant and seasonal farmworkers patients under a contract with the grantee, should be considered as a seasonal service site.
HRSA Response
HRSA has revised the PIN to include a new section that focuses only on migrant voucher screening sites (Section III.B (f)). In addition, the new PIN provides more instructions for grantees on the recording of these sites.
Issue: Clarifying Definitions of Site Types and "Other Activities"
Comments
Most of the commenters requested that Mobile Teams be included as permissible sites on the same basis as Mobile Vans. As described by commenters, Mobile Teams are groups of clinical providers, in some instances accompanied by outreach or other non-clinical staff, who provide primary care services to people who are unable or unwilling to obtain services at a more traditional health center service site – often migrant and seasonal farmworkers or persons experiencing homelessness. While many commenters suggested that the “Special Instructions for Recording Mobile Van Sites” in the PIN very appropriately allows the van itself to be considered a site without requiring the locations at which it stops to be listed, many also suggested that a mechanism for including Mobile Teams in the scope of project should also be established.
Many commenters also suggested a number of arrangements that should be given independent classification as a type of site or suggested other activities that could be captured under “Other Activities” in the PIN. A number of commenters suggested that the draft PIN lacked clarity regarding clinical outreach activities (i.e., intermittent services by a medical provider at an alternative location to engage hard-to-reach populations with intent to arrange for follow up care at the health center) and suggested the creation of a category that explicitly describes clinical outreach. In addition, commenters requested that HRSA clarify that additional health services such as "surgery at hospitals" and "surgery at ambulatory surgery centers" are acceptable "other activities" that can be included in a health center's scope.
HRSA Response
The PIN has been revised to provide further clarity on the different types of service sites and provides instructions to grantees on the recording of such activities in the “Other Activities” section including the distinction between clinical and non-clinical outreach teams. In addition, the final PIN provides further clarification for grantees on the recording of intermittent sites and “Other Activities” that are relevant to the recording of these types of arrangements.
HRSA recognizes that in order to provide a continuum of care for their patients, health centers may, on occasions, provide care to patients in hospitals and other locations. As appropriate, services and sites should be recorded in accordance with the definitions and policies outlined in the PIN.
Issue: Subcontractor/Subrecipient Arrangements
Comments
One commenter noted that it would be helpful for HRSA to provide clarification on whether changes in elements of scope undertaken by subcontractors are subject to the same sort of prior approval as changes by grantees. Many commenters also noted that further explanation of prior approval requirements for changes to subrecipient arrangements would be useful.
HRSA Response
HRSA recognizes this is an area for further policy development. Subrecipients must be compliant with all of the requirements of Section 330 to be eligible to receive FQHC reimbursement for both Medicare and Medicaid. Sub-recipient and sub-contractor arrangements must be documented through written contracts/agreements and updated as changes occur in the arrangements.
Issue: Clarifying Services and Services Provided Form
Comments
A number of commenters suggested that the expectation for a service included in a health center's approved scope of project be equally available to all patients is unrealistic given the resource limitations of health centers. One commenter also suggested that a health center should be allowed to limit primary care services only to a special population served at a site (such as those who are homeless or have serious mental illness) and that specific services provided on a regular basis to a special population should not have to be configured to serve the larger target population as long as the larger population can access services at other sites.
HRSA Response
HRSA recognizes that health centers operate with limited financial resources in their efforts to maximize care to the underserved in their communities. It is a requirement that all services included in a health center's scope of project must be available and accessible, as appropriate, and in a manner which will assure continuity of service to residents of the center's catchment area regardless of the population served.
Issue: Define FQHC Benefits & Scope
Comments
Many commenters suggested that HRSA should articulate that determinations on scope of project should be binding for purposes of eligibility for other section 330-related benefits such as FTCA coverage and 340b participation, among others.
HRSA Response
Section 330 scope of project defines eligibility for participation in many different programs which each have their own additional requirements that must also be satisfied. The FTCA and 340b Programs have separate requirements and processes apart from the change is scope approval process. Grantees should contact the HRSA's FTCA Program for further information pertaining to FTCA coverage and the HRSA Office of Pharmacy Affairs for more information pertaining to the 340b Program.
Comments
Many commenters requested clarification from HRSA on the expectation for grandfathering of existing/previously approved arrangements that are within a grantee's approved scope of project. Many suggested that the current arrangements should be allowed to remain in scope regardless of policy changes, provided that the health center can provide adequate justification for the service/site. Further, commenters suggested that HRSA should allow health centers the opportunity to update their scope of projects based on the policy change to do so by submitting revised scope forms and, as necessary, simple explanations or justifications, rather than filing a complete change in scope request.
HRSA Response
As necessary, HRSA will provide all grantees with an opportunity to update their scope of project information. HRSA will work with grantees to resolve any potential issues. |
