Form 2 Checklist for Adding New Service -Clean

Checklist for Adding a New Service

Assurances:

OMB No.: 0915-0285. Expiration Date: XX/XX/20XX

• I certify that the following statements related to the preparation of this Change in Scope (CIS) request are true, complete and accurate:

• This CIS request is complete and responsive to all applicable criteria relating to the CIS checklist. Refer to http://www.bphc.hrsa.gov/programrequirements/scope.html for all applicable policies and guidance.

• The health center consulted with its Project Officer prior to submitting this CIS request.

• The proposed CIS implementation date is at least 60 days from the submission date to HRSA. Note: HRSA recognizes that there may be circumstances where submitting a CIS request at least 60 days in advance of the desired implementation date may not be possible; however, the goal is to minimize these occurrences through careful planning.

• The health center’s governing board approved this CIS request prior to submission to HRSA, as documented in board minutes (must be made available upon request).

• The health center has examined the potential impact of this CIS under the requirements of other programs as applicable (e.g., 340B Program, FTCA). Refer to: https://www.bphc.hrsa.gov/programrequirements/pdf/potentialimpactofcisactions.pdf

• The health center understands that HRSA will consider its current compliance with Health Center Program requirements and regulations (i.e., the status and number of any progressive action conditions) when making a decision on this CIS request. See Health Center Program Compliance Manual, Chapter 2: Health Center Program Oversight for more information on progressive action. Refer to: https://bphc.hrsa.gov/programrequirements/compliancemanual/index.html

• I will ensure the health center complies with the following statements related to the implementation of this Change in Scope (CIS) request, if approved:

• All Health Center Program requirements (http://www.bphc.hrsa.gov/programrequirements/index.html) will apply to this CIS. Note: Compliance with Health Center Program requirements across sites and services will be assessed through all appropriate means, including site visits and application reviews.

• This CIS will be undertaken directly by or on behalf of the health center for the benefit of the current or proposed health center patient population, and the health center’s governing board will retain oversight over the provision of any services and/or sites.

• This CIS will be accomplished without additional Health Center Program Federal award funding (for awardees only) and will not shift resources away from carrying out the current HRSA-approved scope of project.

• The impact of this CIS will be reflected in the total budget submitted with the health center’s next annual competing or non-competing or designation application.

• This CIS will be implemented and verified within 120 days of receiving the NoA or HRSA notification approving the change.

• This CIS will not diminish the patient population’s access to and quality of services currently provided by the health center.

• The health center will take all applicable steps related to the requirements of other programs impacted by this change in scope request. Refer to https://www.bphc.hrsa.gov/programrequirements/pdf/potentialimpactofcisactions.pdf

Change in Scope Questions:

Is this request to add a service linked to another recently submitted, in progress or planned CIS request? (e.g., the health center will be adding a new site where this service will be provided) – Y/N – require text box explanation if Y

1. OVERVIEW: Provide a brief description of:

• The proposed service to be added (reference the Form 5A Service Descriptors);

• The level of services requested. Include a summary of typical services, consults and procedures to be provided and/or attach a copy of the providers’ privileging list.

• Staff that would be involved in providing the service (providers, contractors, and/or support staff)

Requires narrative response.

Optional Attachment: Privileging List

Proposed Date of Service Addition: mm/dd/yyyy

Note: Please review Program Assistance Letter 2014-10: Updated Process for Change in Scope Submission, Review and Approval Timelines and Policy Information Notice 2008-01: Defining Scope of Project and Policy for Requesting Changes. In cases where a health center is not able to determine the exact date by which a CIS will be fully accomplished, BPHC will allow up to 120 days following the date of the CIS approval Notice of Award (NoA) or look-alike Notice of Look-Alike Designation (NLD) for the health center to implement the change (e.g., begin providing a new service). Review Program Assistance Letter 2009-11: New Scope Verification Process for more information.

2. NEED & UTILIZATION: Discuss why and how the addition of the proposed service will meet the health needs of the population served by the health center.

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

• UDS trend data and/or a needs assessment indicate a high need for the service.

• Community-based data such as survey, focus group, request from community group, etc., indicate a high need for the service.

• An existing provider is closing a site and/or is no longer offering the service to the patient population.

• Other – describe: requires narrative response

2. Provide evidence that the proposed service will meet the health needs of the population served by the health center. Provide data only for the new service.

Total number of patients projected to be served annually:

New patients____

Existing patients____

Of the total projected patients, anticipated % of patients with incomes at or below 200% of the Federal Poverty Guidelines: ____

Briefly explain how these projections were derived: _________________________

3. Using the most recent UDS data and/or other data specific for the patient population and/or service area, describe any demographic characteristics (e.g., age range, gender(s), race/ethnicity) and associated risk factors (e.g., occupational, environmental, behavioral, social/cultural, housing status) that demonstrate the need for and/or benefit of the proposed service.

Requires narrative response

4. If specialty selected on 5A

Specialty Service and Support of Primary Care: Discuss how the proposed specialty service will:

• Support the provision of the health center’s required primary care services; and

• Function as a logical extension of these required primary care services.

Note that not all specialist care is appropriate for inclusion within the federal Health Center Program scope of project (e.g., inpatient/hospital-based services such as critical care and chemotherapy infusion).

Requires narrative response

5. ACCESS FOR CURRENT PATIENTS: Demonstrate how the health center will ensure all current patients will have access to the proposed new service. Check all that apply. Multiple choice checkboxes.

• This service is being provided at all existing site(s)

• Provider(s) will travel between sites

• Patient transportation will be provided between sites

• Patient transportation will be provided to a non-health center site

• Other – please describe: requires narrative response

6. ACCESS FOR NEW PATIENTS: Describe how the health center will ensure any new patients accessing this new service will have access to the health center’s existing in scope services (including coordination with primary care providers of new patients, if applicable).

Requires narrative response.

3. SERVICE DELIVERY METHOD AND LOCATION (not required if health center is proposing to provide the service directly via Column I)

For Services Provided via Formal Written Agreement With the Health Center (Form 5A, Column II):

For a proposed service provided via a Formal Written Agreement (where the health center is accountable for paying/billing for the direct care provided via the agreement – generally under a contract), describe:

• The activities to be performed by the contractor/provider in the provision of the service;

• How the services provided under the agreement will be documented in the health center patient record; and

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

Requires narrative response

No attachment requested/required

For Services Provided via Formal Written Referral Arrangement With the Health Center (Form 5A, Column III):

For a proposed service provided via a Formal Written Referral Arrangement (where the referral is within the scope of project but 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 (Note: 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), describe:

• How the referral arrangement is documented (i.e., via an MOU, MOA, or other formal agreement);

• How the referral arrangement addresses the manner by which the referral will be made and managed; and

• How the referral arrangement addresses the tracking and referral of patients back to the health center for appropriate follow-up care.

Requires narrative response

No attachment requested/required

Public Burden Statement: Health centers (section 330 grant funded and Federally Qualified Health Center look-alikes) deliver comprehensive, high quality, cost-effective primary health care to patients regardless of their ability to pay. The Health Center Program application forms provide essential information to HRSA staff and objective review committee panels for application evaluation; funding recommendation and approval; designation; and monitoring. The OMB control number for this information collection is 0915-0285 and it is valid until XX/XX/XXXX. This information collection is mandatory under the Health Center Program authorized by section 330 of the Public Health Service (PHS) Act (42 U.S.C. 254b). Public reporting burden for this collection of information is estimated to average 2 hours per response, including the time for reviewing instructions, searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA Reports Clearance Officer, 5600 Fishers Lane, Room 14N136B, Rockville, Maryland, 20857 or paperwork@hrsa.gov.