Form 1 Checklist for adding new service

CIS Editable Checklist – Grantee Checklist – Add Service

Change Checklist

DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration CHECKLIST FOR ADDING A SERVICE (CHKLST001)	Grantee Name:
	Grantee Number:
	CIS Tracking Number:

Questions for Addition of Service(s)

Unless otherwise noted, responses are required for all questions when requesting to add a Required OR Additional (including Specialty) Service.

In this CIS request, you have proposed to add the following service to scope:

When do you plan to start providing the service(s)?

(mm/dd/yyyy):

1. NEED
Respond to ALL of the following questions to clearly address why and how the addition of the proposed service will address unmet need and further the mission of the health center by maintaining or increasing access and maintaining or improving quality of care for the target population.

1a. How was the need for the proposed service identified (check all that apply)?

UDS Trend Data and/or a needs assessment indicated a high need for services.
UDS Data Year (20 ) Needs assessment completed on (mm/dd/yyyy):
Community asked us to provide the service and provided supporting needs data.
An existing clinic is closing and/or a referral provider is no longer offering the service to our patients and we wish to offer the service directly.
Other (Describe):
Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)

1b. Using the most recent UDS data and/or other data specific to your target population and/or service area, describe any demographic characteristics of the current patient and/or target population (e.g. age range and gender(s), and race/ethnicity, as appropriate) that support the need for and/or benefit of the proposed service.

Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)

1c. Using the most recent UDS data and/or other data specific to your target population and/or service area, describe any risk factors within the current patient and/or target population not already noted in the demographic characteristics (e.g., occupational, environmental, behavioral, social/cultural, or housing status) that support the need for and/or benefit of the proposed service.

Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)

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ONLY APPLICABLE FOR ADDITIONAL SERVICES, INCLUDING SPECIALTY SERVICES

2. MAINTENANCE OF CURRENT SERVICE CAPACITY
Clearly address how adding this service will NOT eliminate or reduce access to a required service; and/or result in the diminution of the health center's total level or quality of health services currently provided to the target population by addressing ALL of the following questions.

2a. Describe your current capacity and ability, utilizing at minimum the most recent UDS data available, to provide all REQUIRED primary care services (e.g. Preventive Dental, OB/GYN, etc.) either directly and/or through formal arrangements, to the target population (e.g. Is the health center at capacity for preventive dental visits?).

Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)

2b. Specifically, utilizing at minimum the most recent UDS data available and if necessary, other data sources specific to your target population and/or service area, demonstrate why this proposed service has been determined to be a priority over any other area of unmet need (e.g. why is the health center adding this particular Additional Service instead of expanding adult preventive dental services?).

Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)

ONLY APPLICABLE FOR ADDITIONAL SERVICES, INCLUDING SPECIALTY SERVICES

3. PROJECTED SERVICE UTILIZATION
Provide evidence that the proposed service will appropriately focus on the current patient and/or target population by providing the following information about the population that will utilize the new service.

3a.Number of patients projected to be served annually This is the anticipated number of patients that will utilize the proposed service in the coming calendar year.	Number: (Format: 99) Data Source Used for Projection: Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)
3b. Percentage of projected patients at or below 200% of Federal Poverty Guidelines This is the anticipated % of patients with incomes at or below 200% of the Federal Poverty Guidelines that will utilize the proposed service in the coming calendar year.	Percentage: % (Format: 9 or 9.99) Data Source Used for Projection: Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)
3c. Percentage of projected uninsured patients This is the anticipated % of uninsured patients that will utilize the proposed service in the coming calendar year.	Percentage: % (Format: 9 or 9.99) Data Source Used for Projection: Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)

3d. Provide a brief narrative description on how the projections in 3a, b, and c were derived.

Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)

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Note : ONLY APPLICABLE FOR ADDITIONAL SERVICES, INCLUDING SPECIALTY SERVICES

4. ACCESS AND COORDINATION FOR NEW PATIENTS
For individuals that become new patients of the health center by accessing the proposed new service:

4a. How will these new patients be assured access to the full scope of existing required and additional services the health center provides?

Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)

4b. If new patients have existing (non-health center) primary care providers, describe how the health center will coordinate and follow-up with such providers.

Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)

5. ACCESS TO NEW SERVICE FOR CURRENT PATIENTS
Describe the health center's plans to assure all patients will have reasonable access to the proposed new service, as appropriate.

Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)

6. SLIDING FEE DISCOUNT PROGRAM
Will the health center offer its current sliding fee discount program (sliding fee discount schedule, including any nominal fees and related implementing policies and procedures) for the proposed service to patients with incomes at or below 200 percent of the Federal Poverty Guidelines, and ensure that no patients will be denied access to the service due to inability to pay?

Yes

No

6a. Will the sliding fee discount schedule for the proposed service differ from the health center's existing sliding fee discount schedule(s)?

Yes

No

If Yes, explain how and why and attach the applicable sliding fee discount schedule for the proposed service.

Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)

Sliding Fee Discount Schedule (Maximum 6 attachments)
Select	Purpose	Document Name	Size	Uploaded By	Description
No attached document exists.

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7. FINANCIAL IMPACT ANALYSIS

Template Name	Template Description	Action
Financial Impact Analysis	Template for Financial Impact Analysis
Instructions	Instructions for Financial Impact Analysis

Attach Financial Impact Analysis Document here.

Financial Impact Analysis (Maximum 6 attachments)
Select	Purpose	Document Name	Size	Uploaded By	Description
No attached document exists.

7a. Explain how the addition of the proposed service to scope will be accomplished and sustained without additional section 330 Health Center Program funds. Specifically (referencing the attached Financial Impact Analysis, as necessary) describe how 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 service.

The Financial Impact Analysis must at a minimum show a break-even scenario or the potential for generating additional revenue.

Additional revenue (program income) obtained through the addition of a new service must be invested in activities that further the objectives of the approved health center project, consistent with and not specifically prohibited by statute or regulations.

Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)

7b. Is this change in scope dependent upon any special grant, foundation or other funding that is time-limited, e.g., will only be available for 1 or 2 years?

Yes

No

If Yes, how will the new service be supported and sustained when these funds are no longer available? Describe a clear plan for sustaining the service.

All time-limited or special one-time funds should be clearly identified as such in the Financial Impact Analysis.

Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)

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8. STAFFING
Provide a clear and comprehensive description of the relevant staffing arrangements made to support the proposed new service and to ensure staffing is/will be sufficient to meet any projected patient/visit increases. (The discussion of “staffing” should include non-health center employees if the service will be provided via contract/contracted providers or subrecipient arrangements.) In addition, describe any potential impact on the overall organization’s staffing plan (reference the Financial Impact Analysis as applicable).

Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)

9. HEALTH CENTER STATUS
Discuss any major changes in the health center’s staffing, financial position, governance, and/or other operational areas, as well as any unresolved areas of non-compliance with Program Requirements (e.g. active Progressive Action conditions) in the past 12 months that might impact the health center’s ability to implement the proposed change in scope.

Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)

10. CREDENTIALING AND PRIVILEGING
How has the health center planned for the appropriate credentialing and privileging of the provider(s) that will provide the proposed service in accordance with PIN 2002-22 ?

In responding, consider the following:

• It is the responsibility of the health center to ensure that all credentialing and privileging of providers have been completed BEFORE providing the service as part of their Federal scope of project. This includes services provided either Directly (Column I) OR via a (Column II) Formal Written Agreement (e.g. contract). For services provided via a Formal Written Referral Arrangement (Column III), the referral provider should be able to assure (within the arrangement) to the health center that all their providers are appropriately credentialed and privileged individually.

• The health center’s current board-approved policy must cover the required verification of credentials and establishment of privileges to perform any new activities and procedures expected of providers by the health center or be updated to do so (for services provided either Directly (Column I) OR via a (Column II) Formal Written Agreement). In addition, a new or updated privileging list approved by the Clinical Director/Chief Medical Officer or other appropriate Clinical Leadership that delineates the specific services and procedures that the provider is privileged to provide on behalf of the health center (i.e. specific to the health center and not other organizations where the provider might serve patients e.g. hospitals) must also be in place.

Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)


Attach the relevant Clinical Director/Chief Medical Officer-approved Privileging Lists. Note that the attached Privileging Lists Must Address:

• Typical level of services to be provided on behalf of the health center (e.g. consults vs. procedures and/or a specific list of services)

• Typical procedures to be provided as part of the service on behalf of the health center (i.e. a specific list of procedures)

MEDICAL DIRECTOR/CMO-APPROVED PRIVILEGING LIST(S) (Maximum 6 attachments)
Select	Purpose	Document Name	Size	Uploaded By	Description
No attached document exists.

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11. QUALITY IMPROVEMENT/ASSURANCE PLAN
How will the proposed new service be integrated into and assessed via the health center's quality improvement/assurance and risk management plans? In responding, address the following:

• Will it be integrated into the QI/ QA plan using existing performance measures be applied to the service or will new measures be created specifically for the new service?

• Are board-approved peer and chart review policies in place by which any provider(s) of the proposed new service will be assessed?

• Are risk management plans in place to assure the new service has appropriate liability coverage (e.g. non-medical/dental professional liability coverage, general liability coverage, automobile and collision coverage, fire coverage, theft coverage, etc.)?

Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)

12. SERVICE DELIVERY METHOD AND LOCATION

12a. If the proposed service will be provided via a Formal Written Agreement (Form 5A, Column II) where the health center is accountable for paying/billing for the direct care provided via the agreement (generally a contract) - does the formal written agreement between the health center and the contractor/provider(s) state, address or include:
The activities to be performed by the contractor/provider in the provision of the service, specifically including:

• How the services provided will be documented in the health center patient record?

• How the health center will bill and/or pay for these services provided to health center patients?

Yes

No

Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)

List Page #(s) :

The time schedule for such activities (e.g. provider hours/schedule)?

Yes

No

Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)

List Page #(s):

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The policies and requirements that apply to the contractor, including those required by 45 CFR 74.48 or 92.36(i) and other terms and conditions of the grant? These may be incorporated by reference where feasible – See the HHS Grants Policy Statement for more information on public policy requirements applicable to contractors at: http://www.hrsa.gov/grants/hhsgrantspolicy.pdf pages II-2 to II-6

Yes

No

Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)

List Page #(s):

The maximum amount of money for which the health center may become liable to the contractor/provider under the agreement?

Yes

No

Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)

List Page #(s):

Provisions consistent with the health center’s board approved procurement policies and procedures in accordance with 45CFR Part 74.41-48?

Yes

No

Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)

List Page #(s):

Assurances that no provisions will affect the health center’s overall responsibility for the direction of the services to be provided and accountability to the Federal government by reserving sufficient rights and control over the services to the health center to enable it to fulfill its responsibilities?

Yes

No

Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)

List Page #(s):

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Requirements that the contractor/provider maintain appropriate financial, program and property management systems and records and provides the health center, HHS and the U.S. Comptroller General with access to such records, including the submission of financial and programmatic reports to the health center if applicable and comply with any other applicable Federal procurement standards set forth in 45CFR Part 74 (including conflict of interest standards)?

Yes

No

Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)

List Page #(s):

Provision that such agreement is subject to termination (with administrative, contractual and legal remedies) in the event of breach by the contractor/provider?

Yes

No

Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)

List Page #(s):

It is the responsibility of the health center to ensure that the agreement does NOT inappropriately imply the conference of the benefits and/or privileges of Health Center Program grantees or FQHC Look-Alikes such as 340B Drug Pricing, or FQHC reimbursement, on the other party.

Attach the agreement for the service (draft agreements are acceptable) here.

Service Delivery Method and Location A (Maximum 6 attachments)
Select	Purpose	Document Name	Size	Uploaded By	Description
No attached document exists.

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12b. If the proposed service will be provided via a Formal Written Referral Arrangement (Form 5A, Column III) where the actual service is provided and paid/billed for by another entity (the referral provider) and thus the service itself is NOT included in the health center's scope of project but the establishment of the actual referral arrangement and any follow-up care provided by the health center subsequent to the referral are included in scope – is the proposed referred service:

Documented via an MOU, MOA, or other formal agreement that at a minimum describes the manner by which the referral will be made and managed, and the process for tracking and referring patients back to the health center for appropriate follow-up care?

Yes

No

Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)

List Page #(s):

Available equally to all health center patients, regardless of ability to pay?

Yes

No

Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)

List Page #(s):

Attach the referral arrangement documentation (draft documents are acceptable) here.

Service Delivery Method and Location B (Maximum 6 attachments)
Select	Purpose	Document Name	Size	Uploaded By	Description
No attached document exists.

It is the responsibility of the health center to ensure that the arrangement does NOT inappropriately imply the conference of the benefits and/or privileges of Health Center Program grantees or FQHC Look-Alikes such as 340B Drug Pricing , or FQHC reimbursement, on the other party.

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12c. Will the proposed service be provided at an existing site (see Form 5B) and/or Location (see Form 5C) within the approved scope of project?

Yes

No, but site or location where proposed service will be provided will be added to scope via a separate CIS Request as appropriate.

Review PIN 2008-01 for more information on the definition of a service site or other location at: http://www.bphc.hrsa.gov/policiesregulations/policies/pin200801defining.html
Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)


The service must be provided at an approved site within the scope of project, a proposed new site with reasonable access to all available services in the health center’s scope of project, or at a location where in-scope services or referrals are provided but that does not meet the definition of a service site.

ADDITION OF SPECIALTY SERVICES ONLY APPLICABLE TO SPECIALTY SERVICES THAT WILL BE PROVIDED DIRECTLY AND/OR THROUGH FORMAL WRITTEN AGREEMENTS (FORM 5A COLUMNS I AND/OR II)

In this CIS request, you have proposed to add the following specialty service to scope: Service has not been selected.

If the proposed specialty service is approved for addition to the scope of project, health centers are reminded that the full range of services within a specialist's area of expertise may or may not be within the Federal scope of project. Rather ONLY those specific aspects of the specialty service as described within this change in scope request will be considered included within the approved scope of project.

13. SPECIALTY SERVICE DESCRIPTION
Describe the proposed specialty service; address all of the following elements.

• The specialty area (e.g., endocrinology, ophthalmology)

• IF NOT ALREADY ADDRESSED IN QUESTION 8, discuss the specific level of staffing necessary to implement the proposed specialty service, in particular whether additional staff (above and beyond the specialist provider, e.g. nurses, additional medical assistants) and/or equipment (e.g. echocardiogram) will need to be added to scope and supported under the health center's budget in order to implement the Specialty Service. As a reminder, these costs should be appropriately reflected in the change in scope Financial Impact Analysis.

Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)

14. SPECIALTY SERVICE AND SUPPORT OF PRIMARY CARE
Demonstrate how the proposed specialty service will support the provision of the required primary care services already provided by the health center and function as a logical extension of or complement these required primary care services.

Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)

Upload any supporting attachments related to the proposed Specialty Service here.

Proposed Specialty Service (Maximum 6 attachments)
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Additional Considerations for Adding a Service to Scope

While the following areas are not specific factors or criteria that will impact the CIS approval process, these are key elements that health centers should have considered or actively planned to address prior to adding a new service to scope:

A. Medical Malpractice Coverage Your health center must develop plans for medical malpractice coverage for any new providers including any specialty providers (e.g., extension of FTCA coverage, private malpractice coverage). Respond the following as applicable:

For grantees deemed under the FTCA, have you reviewed the FTCA Health Center Policy Manual or if appropriate, consulted with BPHC to assure the applicability of FTCA coverage?

The FTCA Health Center Policy Manual is available at: http://www.bphc.hrsa.gov/policiesregulations/policies/pin201101.html For specific questions, contact the BPHC HelpLine at: 1-877-974-BPHC (2742) or Email: bphchelpline@hrsa.gov. Available Monday to Friday (excluding Federal holidays), from 8:30 AM – 5:30 PM (ET), with extra hours available during high volume periods.

Yes	Not Applicable, health center is not deemed or FTCA coverage does not apply.

If you selected “Not Applicable” respond to the question below.

For health centers not deemed under the FTCA or if FTCA coverage is not applicable to the service, have you developed a plan for medical malpractice coverage?

Yes

No

Briefly explain your response:
Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)

B. Section 340B Drug Pricing Program Participation: Health centers that participate in the 340B Drug Pricing Program are reminded that changes to the scope of project approved by BPHC do not automatically update within the 340B Program’s Database. Health centers should contact the HRSA Office of Pharmacy Affairs to determine whether any updates to the 340 Database are necessary by contacting Apexus Answers at 888-340-2787, or ApexusAnswers@340bpvp.com.

Will your health center complete all necessary 340B Program updates with the HRSA Office of Pharmacy Affairs?

Yes	Not Applicable, health center does not participate in the 340B program

Briefly explain your response:
Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)

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C. Facility Requirements:
Has your health center assured that any/all Federal, State and local standards/accreditation requirements of the facility where the proposed new service will be provided have been fully met (including those associated with CMS FQHC certification)?

Yes	Not Applicable

Briefly explain your response:
Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)

D. Reimbursement as a Federally Qualified Health Center (FQHC) under Medicaid and/or CHIP: The Medicaid statute and program guidance require that an FQHC’s Medicaid reimbursement rate be adjusted to reflect changes in the “type, intensity, duration, and/or amount of services” provided. Therefore, a HRSA-approved change in the services covered under a health center’s scope of project may necessitate a change in the health center’s FQHC Medicaid reimbursement rate. In these situations, it is the responsibility of the health center to notify its State Medicaid Agency of the change(s) in services following HRSA approval and prior to billing for the new service. For further information about the process for adjusting rates based on changes in services provided, health centers should contact their Primary Care Association or State Medicaid Agency.

After HRSA approval of the change in scope but prior to billing for the service, will your health center notify the State Medicaid Agency of any changes to services covered under the HRSA scope of project that may affect your center’s Medicaid reimbursement rate?

Yes	Not Applicable

Briefly explain your response:
Maximum paragraph(s) allowed approximately: 3 (3000 character(s) remaining)

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