IV. Change in Scope Requests

Some changes in the approved scope of project require prior approval from HRSA before being initiated; others may be implemented by the grantee without prior approval. In all cases, any changes proposed and/or implemented by a grantee must assure continued compliance with the applicable statutory, regulatory and policy requirements. In reviewing a request to change the approved scope of project, HRSA will consider whether the request furthers the mission of the health center by increasing or maintaining access and improving or maintaining the quality of care for the target population. Requests must not result in the diminution of the grantee's total level or quality of health services currently provided to the target population. Additionally, grantees are reminded that a request to change the approved scope of project must not shift resources away from providing approved services for the target population, and must be accomplished without additional Health Center Program funding. As appropriate, changes in the approved scope of project also must assure continued service to a Medically Underserved Area (MUA) or a Medically Underserved Population (MUP). (Please note, a service site does not have to be located in an MUA in order to serve people living in the area.)

A. Change in Scope Requests that Require Prior Approval

1. Types of Change in Scope Requests that Require Prior Approval
Based on applicable section 330 program regulations, 42 CFR Part 51c.107(c), 45 CFR Parts 74 and 92, and HHS Grants Policy Statement, prior approval is required for significant changes in the approved budget or program plan including scope of project.18 The following five types of changes are considered significant and, therefore, require prior approval from HRSA:

• Adding a service site not included on Form 5 – Part B: Service Sites, of the grantee's most recent application for Federal support or approved change in scope request.
• Adding a service not included on Form 5 – Part A: Services Provided, of the grantee's most recent application for Federal support or approved change in scope request.
• Relocating a service site that was included on Form 5 – Part B: Service Sites, of the grantee's most recent application for Federal support or approved change in scope request.
• Deleting a service site that was included on Form 5 – Part B: Service Sites, of the grantee's most recent application for Federal support or approved change in scope request.
• Deleting a service that was included on Form 5 – Part A: Services Provided, of the grantee's most recent application for Federal support or approved change in scope request.

Grantees should include in their change in scope request a detailed discussion of any potential impact on the total approved section 330 project budget, services provided, number of patients served, and number and type of providers. Any unique circumstances that are expected to impact the ability of the grantee to meet the expectations for change in scope requests must be fully explained and documented.
Note: Any request for change in scope of project must be accomplished without additional section 330 funds. Requests for change in scope of project must be approved by the Board of Directors of the grantee with approval documented in the Board minutes prior to submission to HRSA.
Because of the importance of the scope of project, it is expected that grantees will submit any change in scope request requiring prior approval at least 60 days in advance of their desired implementation date , to the extent practicable, following the process described in Section V of this PIN (see Process for Change in Scope of Project Requests).

2. Special Instructions for Adding a Service Site19

a. Adding Sites in the Same Building, Complex or Campus
Health centers may identify an opportunity to add a new location that meets the definition of a service delivery site (see Definition of a Service Site) within the same building or complex/campus where they are already have an established service delivery site providing services to the target population. In such an instance, a health center must complete a change in scope for prior approval to add the new site if the site would have a separate physical address including a different suite/office/building number. For example, a change in scope of project is required if a grantee operates a site at 345 Main Street, Suite #4 and will be adding a new site at 345 Main Street, Suite #12. If the location does not create a separate physical address, no change in scope is required.

b. Adding Migrant Voucher Screening Sites
If a grantee needs to add a new migrant voucher screening site, the grantee must submit a change in scope request for prior approval to add the new screening location. No change in scope request is necessary to add/delete the specific locations where the grantee maintains contracts for direct services.

c. Changing from Intermittent to Permanent or Seasonal Sites
Grantees may determine that demand for primary care services from the target population at an intermittent site exceeds their expectation to provide services at that location for only a short period of time. If a grantee determines that the intermittent site should be operated for more than the expected period of time for an intermittent site (two months or less), and the site meets the definition of a service site (see Definition of a Service Site), the grantee must complete a change in scope request to add the location as a permanent or seasonal service site.

d. Sites Offering a Single Service
Although grantees are not required to provide all services at all service sites, patients must have reasonable access to the full complement of comprehensive services offered by the health center as a whole. The establishment of a single service or limited service site must be in a location that allows reasonable access to the full complement of services from the health center or access to the required services on a sliding fee scale basis through formal arrangements with other providers in the community.

3. Special Instructions for Adding a Service
While grantees may deliver a service by several different methods, a service will only be included in the grantee's scope of project if it is delivered directly by the grantee or through a formal written agreement such as a contract, purchase agreement, and/or written arrangement as recorded Form 5- Part A, Services, Columns I and II. Although the arrangement with another provider under a formal referral arrangement (recorded under Column III on Form 5 – Part A) is within a grantee's scope of project, the actual service provided by the other provider under the arrangement is not included in a grantee's scope of project; therefore, if a grantee has been providing a service only through a formal or informal referral arrangement and wishes to begin providing this service directly or through formal agreement as part of their scope of project (e.g., the service is ONLY recorded in Column III and is being moved to Columns I and/or II on Form 5- Part A), the grantee MUST submit a change in scope request to add the service to the scope of project and begin providing this service.
Cases where a grantee moves a service(s) from one site to another site in the approved scope of project do not require prior approval. However, in doing so, grantees should assure that the population accessing the service at the original site will continue to have reasonable access to the service once it is relocated.

4. Special Instructions for Relocation of a Site
Health centers may engage in different types of relocations to maximize access to services for the target population.
In some cases, this may involve complete relocation, and in others, only partial relocation. Grantees moving all clinical services from an approved permanent or seasonal service site to a new location must submit a request for prior approval to relocate the service site. Requests for relocation will be examined to assure continued access for the populations served by the service site to be relocated. Such requests should demonstrate that the relocation furthers the mission of the health center by increasing or maintaining access and improving or maintaining the quality of care for the target population currently served by the grantee. Requests for relocation must not result in the diminution of the grantee's total level or quality of health services currently provided to the target population.
Cases where a grantee is moving only a portion of its current clinical services from an approved permanent or seasonal service site to a new location that is not a part of the approved scope of project, are not considered a relocation of the service site but rather, the addition of a new service site. In this situation, the grantee must submit a change in scope request to add a service site for the new location as the existing site will continue to operate as a service site, meeting the definition described above in III.B.1. (see Definition of a Service Site).
Changes in locations for intermittent sites (when operated for two months or less) are not considered relocations and, therefore, do not require prior approval. However, if an intermittent site becomes a permanent or seasonal site (i.e., will be operated for more than two months), the grantee must submit a change in scope request to add the site as a permanent or seasonal site.

5. Special Instructions for Deleting a Site or Service
There may be circumstances that require grantees to cease operation of a site or the provision of a particular service. Because of the potential implication on access to care for the target population, any request to delete a service or service site from a grantee's scope of project will not be approved without a full examination of the issues surrounding the perceived need to delete the site or service. Grantees are reminded that the deletion of a site or a service must not result in elimination or reduction in access to required services under section 330 of the PHS Act for populations currently served by the health center. Grantees must demonstrate that the requested deletion will not reduce access to services or the ability of current patients to receive the same level of care. As a reminder, grantees must provide all required services directly or through an established arrangement (i.e., a formal written contract/agreement or a formal written referral arrangement); therefore, a grantee may not request to delete a required service.

6. Special Considerations for Changes in Scope of Project

a. Future Federal Funding to Support a Change in Scope Request
A key requirement for every change in scope request is that the grantee must document that the requested change can be fully accomplished with no additional Federal support. In other words, in a request to add a site or service a grantee must demonstrate that adequate revenue will be generated to cover all expenses as well as an appropriate share of overhead costs incurred by the health center in administering the new site or service. If additional Federal funds will be necessary to fully implement the proposed change in scope, it will not be approved. Grantees that require additional Federal grant support to implement the proposed change should consider competitive funding opportunities. Specific eligibility for additional Federal support will be included in each announced funding opportunity.
Grantees considering submitting a change in scope to add a service delivery site that will be the basis for later submission of a competitive grant application (i.e., for Expanded Medical Capacity) should proceed with care. As stated previously, a change in scope request must include only the level of services that can be maintained without additional Federal support. Grantees are strongly advised against establishing a new service or site that is dependent on new future grant support, since such support is not guaranteed.

b. Financial Impact
While many grantees have undertaken changes to their scope of project to improve their financial viability, changes in scope of project that are not carefully planned may pose high risks. A complete financial analysis of the impact of a change in scope is imperative to ensure long-term viability of the health center. In particular, grantees should examine the overall costs of the activity and the potential for reimbursement as part of this analysis. Approval of a change in scope request is contingent on submission of a budget demonstrating break-even (worst case scenario) or the potential for generating additional revenue. Grantees are strongly encouraged to thoroughly review any change in scope request that could result in a significant increase or decrease in the total budget of the health center. Because unforeseen events may occur making original projections inaccurate, grantees should continually monitor the progress of their requested change in scope and be prepared to take action should revenues fail to meet or exceed expenses. Additional revenue obtained through the addition of a new service or site must be invested in activities that further the objectives of the approved health center project, consistent with and not specifically prohibited by section 330(e)(5)(D)3.

c. Impact on Neighboring Health Centers
Health centers should coordinate and collaborate with other section 330 grantees, FQHC Look-Alikes, State and local health services delivery projects, and programs in the same or adjacent service areas serving underserved populations to create a community-wide service delivery system.  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.”20 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.  In addition, continued collaboration among providers will help to ensure that organizations are aware of and, where possible, maximize the benefits of, all organizations.
When a change in scope of project (e.g., the addition or relocation of a service site) is proposed, it is essential that a grantee consider the population(s) served by other existing providers of care, including other section 330 funded health centers, and the impact of the proposed change in scope on the viability of these neighboring health centers. Meeting the health care needs of the community and target population, ensuring that limited Federal grant dollars are used efficiently and effectively to provide access to as many underserved people as possible and the potential impact of a change in scope request on a neighboring health center(s) are key in decisions related to service area overlap.
The potential for service area overlap through a change in scope request will prompt further review, analysis and resolution before HRSA will be able to make a final decision on a health center's request. When a proposed change in scope has the potential to create a service area overlap, documentation of support and/or cooperation from a neighboring health center(s) in the form of a Board of Directors-endorsed letter is desirable. If the health center is not able to document the support of other local providers for its request, it should provide an explanation for the lack of such documentation. In cases where there may be a service area overlap, additional information such as patient origin studies/analyses or an onsite visit may be necessary prior to a final HRSA decision. (See Service Area Overlap PIN, 2007-09 dated March 12, 2007.)

7. Criteria for Prior Approval of a Change in Scope Request

All requests for change in scope of project requiring prior approval (see in Section IV.A. of this PIN: Change in Scope Requests that Require Prior Approval), will be reviewed to determine if the request:

1. will not require any additional section 330 funding to be accomplished;
2. does not shift resources away from providing services for the current target population;
3. furthers the mission of the health center by increasing or maintaining access and improving or maintaining quality of care for the target population;
4. is fully consistent with section 330 of the PHS Act and Health Center Program Expectations including appropriate governing board representation for changes in service sites and populations served;
5. provides for appropriate credentialing and privileging of providers;
6. does not eliminate or reduce access to a required service;
7. does not result in the diminution of the grantee's total level or quality of health services currently provided to the target population;
8. continues to serve a Medically Underserved Area (MUA) in whole or in part, or Medically Underserved Population (MUP)21 [Please note that a service site does not have to be located in an MUA to serve it];
9. demonstrates approval from the health center's Board of Directors, with approval documented in the Board minutes; and
10. does not significantly affect the current operation of another health center located in the same or adjacent service area preferably, but not necessarily, by documenting support to the extent possible from any neighboring health centers.

B. Other Change in Scope Requests

The following changes are not considered significant22 and, therefore, do not require prior approval. Each grantee is expected to discuss any such changes and/or updates in the next application for Federal support.

• Adding a service to a site where both the service and site are already within the approved scope of project. If a grantee currently provides a service within the scope of project, no prior approval is necessary to add the service to a service site already in the approved scope of project. For example, a grantee provides mental health services at one service site and chooses to add that service to another service site already within the approved scope of project no request for prior approval of the change is necessary. The service and service site must be previously documented on Form 5 – Part A: Services Provided and Form 5 – Part B: Service Sites, respectively, of the grantee's most recent application for Federal support or approved change in scope request.
• Change in the number of intermittent sites , previously documented on Form 5 – Part B: Service Sites, of the grantee's most recent application for Federal support or approved change in scope request. The number of such sites should be updated at least annually in the application for Federal support.
• Change to providers listed on Form 2: Staffing Profile of the grantee's most recent application for Federal support or approved change in scope request. Only those requests affecting providers that are linked with changes in sites or services require prior approval. No change in scope request is required in cases where a grantee changes the type of provider used to provide a service under the approved scope of project. For example, if the grantee has been providing mental health services using a social worker and decides to add a psychologist, and there is no change in the services provided (i.e., mental health), the grantee does not need to request prior approval to make this change.
• Change to the hours of operation of a service site previously approved on Form 5 – Part B: Service Sites, of the grantee's most recent application for Federal support or approved change in scope request. The hours for each site should be updated at least annually in the application for Federal support.

Note that any change in scope of project must be accomplished without additional section 330 funds.

C. Change in Scope During Emergencies for Health Centers

During an emergency, health centers are likely to play an important role in delivering critical services and assisting in the local community response. Health centers deemed under FTCA should refer to PIN 2007-16, “Federal Tort Claims Act (FTCA) Coverage for Consolidated Health Center Program Grantees Responding to Emergencies.” (See PIN 2007-16)

For the purposes of this section, an “emergency” or “disaster” is defined as an event affecting the overall target population and/or the community at large, which precipitates the declaration of a state of emergency at a local, State, regional, or national level by an authorized public official such as a governor, the Secretary of the U.S. Department of Health and Human Services, or the President of the United States. Examples include, but are not limited to: hurricanes, floods, earthquakes, tornadoes, wide-spread fires, and other natural/environmental disasters; civil disturbances; terrorist attacks; collapses of significant structures within the community (e.g., buildings, bridges); and infectious disease outbreaks and other public health threats.

In situations where an emergency has not been officially declared, but the health center is unable to operate, HRSA will evaluate on a case-by-case basis whether extraordinary circumstances justify a determination that the situation faced by the health center constitutes an “emergency.”

HRSA recognizes that during an emergency, health centers are likely to participate in an organized State or local response and provide primary care services at temporary locations. Temporary locations include any place that provides shelter to evacuees and victims of an emergency. It also includes those locations where mass immunizations or medical care is provided as part of a coordinated effort to provide temporary medical infrastructure where is it most needed. These temporary locations will be considered part of a health center's scope of project if all of the following conditions are met:

1. Services provided are on a temporary basis;
2. Temporary locations are within the health center's service area or neighboring counties, parishes, or other political subdivisions adjacent to the health center's service area;
3. Services provided by health center staff are within the approved scope of project; and
4. All activities of health center staff are conducted on behalf of the health center.

To assure that the emergency response at temporary locations is considered part of the center's scope of project, the health center must provide the following information to its HRSA Project Officer by phone, e-mail, or fax:

(1) health center name;
(2) the name of a health center representative and this person's contact information; and
(3) a brief description of the emergency response activities. 

Health centers must submit this information as soon as practicable but no later than 15 calendar days after initiating emergency response activities. HRSA will determine on a case by case basis whether extraordinary circumstances justify an exception to this 15-day requirement. If the HRSA Project Officer is not available, the health center should contact the BPHC's main phone line at (301) 594-4110.

If a health center needs to continue operating at a temporary location beyond 90 days from the onset of the emergency, the health center must submit a formal change in scope request to add the site. Health centers are expected to submit the formal request with sufficient time for HRSA processing.

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