ss_0285_submitted_to_OMB-FINAL.post comment 7.22.10

4/21/2010 6:56:32 PM

Supporting Statement

The Health Center Program Application Forms

A. JUSTIFICATION

1. Circumstances of Information Collection

The Health Resources and Services Administration (HRSA) is requesting a revision of OMB approval for forms that are used by several Bureau of Primary Health Care (BPHC) programs providing grant funding to serve medically underserved and vulnerable populations. The forms were previously approved under OMB number 0915-0285, Federally Qualified Health Center (FQHC) Application Forms, and the current expiration date is August 31, 2010.

These forms are used to request funding under Section 330 of the Public Health Service (PHS) Act; change their scope of project; apply for cost-based reimbursement; and apply for drug pricing benefits. For non-grantees, these BPHC forms allow organizations to become designated as Federally Qualified Health Center Look-Alikes the ability to apply for cost-based reimbursement and drug pricing benefits. The revisions include the addition of newly web-based, structured Health Care Plan and Business Plan forms, Scope of Project forms, Capital Improvement/Investment forms and some minor changes to previously approved forms. All revisions are documented below.

BPHC program-specific forms are used by health centers to apply for funding under section 330 (as amended by Public Law 107-251): 330(e) Community Health Centers, Section 330(g) Migrant Health Centers, Section 330(h) Health Care for the Homeless, and Section 330(i) Public Housing Primary Care. These forms are used by those Health Centers that are applying to be designated as a Federally Qualified Health Center (FQHC) Look-Alike organization. FQHC Look-Alike organizations do not receive 330 grant dollars, however, this designation allows the same cost based reimbursement and drug pricing benefits as a section 330 Health Center. In addition, these standardized forms are used to award grant funding and assist in program monitoring. The programs using these forms are as follows: New Access Point Funding (NAP), Service Area Competition (SAC), Expanded Medical Capacity (EMC), Service Expansion (SerXP), Budget Period Renewal (BPRs), Increased Demand for Services, and Capital and/or Facility Investment Improvement projects. These forms are also used to request a change in scope (CIS), designate FQHC Look-Alikes, and re-certifications.

FQHC's are authorized to provide primary and preventive services to medically underserved and vulnerable populations facing barriers in accessing healthcare services, including financial, cultural, linguistic and geographical barriers. FQHC's form a vital component of the integrated safety net for underserved and uninsured children, adults, migrant workers, homeless individuals, and public housing residents in nearly, 8000 communities across the country and serve over 18 million persons.

2. Purpose and Use of Information

The purpose of these forms is to provide information to HRSA staff and objective review committee panels in order to evaluate applications for funding approval, designation and program monitoring. Health centers will use a combination of the application forms to apply for one or more of the various opportunities offered based on their eligibility. Applicants provide information for consideration for the following grants: New Access Point Funding (NAP), Service Area Competition (SAC) funding, Expanded Medical Capacity (EMC), Service Expansion (SerXP), Budget Period Renewal (BPRs), Increased Demand for Services (IDS), Capital and Facility Investment Improvement awards (CIP and FIP). In addition, applicants provide information for consideration for the following non-grants: Change in Scope (CIS) and the FQHC Look-Alike designation and re-certification.

NAP awards provide support for new delivery sites to provide comprehensive primary and preventive health care services. NAP’s can be either new start applicants that do not currently receive funding under section 330, or satellites. Satellite applicants currently receive grant support under section 330, and propose to establish a new access point to serve a new patient population. The EMC awards are for funds to support expanding the medical capacity at sites currently operated by organizations receiving support under the Consolidated Health Center Program. This support expands access to primary health care services by increasing penetration into a health center’s current service area. Strategies for EMC may include expanding existing primary care medical services, adding new medical providers, expanding hours of operations, or providing additional medical services through contractual relationships. SerXP awards are for funds to support expanding or enhancing services in mental health/substance abuse, oral health, vision screening and comprehensive pharmacy services. SAC awards provide support for continued comprehensive primary and preventive health care service delivery in an underserved area or population. BPR are progress reports from Health Center Program grantees to ensure they are meeting program requirements and expectations. IDS awards are for funds to increase the number of total patients and uninsured patients served. Strategies to expand services may include, but are not limited to, adding new providers, expanding hours of operations, and/or expanding existing health center services. CIP and FIP awards are for funds to repair and/or improve service site facilities or add/expand service site facilities. CIS are requests may by the FQHC to change the current approved scope of project as they relate to services offered, sites and other scope activities that require prior approval by Program. FQHC Look-Alike Program is for organizations seeking initial certification or re-certification as a Look Alike. Look Alikes must meet all eligibility requirements of a Section 330 grant, but they do not receive grant funds. These programs ensure and support progress of confirming that a Look Alike maintains it eligibility status.

The forms provide information that is required by the Bureau for reviewing applications, monitoring, and ensuring compliance with conditions of award for the programs mentioned above. The following forms are used to collect the required information:

General Information Worksheet: This form provides summary information on the applicant institution. Specifically, it provides a summary of information related to the proposed project including specific applicant information, the proposed service area, target population, and patient and visit projections.

Planning General Information Worksheet: This form provides summary information for planning grant applicants.

BPHC Funding Request Summary: This form collects program specific project budget estimates.

Documents on File (formerly known as Health Center Checklist): This form provides a checklist of compliance requirements for applicant organizations regarding staffing, governance, and contracting. This is an inventory of key documents used by the governing board and key health center staff for ensuring adequate health center operations.

Staffing Profile: This form identifies the total personnel and number of FTEs to staff the funding request.

Income Analysis: This form displays the estimated non-Federal revenues (all other sources of income ASIDE FROM the section 330 grant funds) for the application budget.

Community Characteristics: This form provides community wide and target population data.

Services Provided: Applicants provide information on the range of services that are provided to clients/patients.

Sites Listing: This form provides information on the site location data (address, contact information and site characteristics like hours of operation of the service sites).

Other Activities/Locations: This form provides information on the location and activities that are provided not at a service site but are considered apart of the Health Center Scope of Project

Board Member Characteristics: This form provides information on board members, areas of expertise, years of service on the board, etc.

Request for Waiver of Governance Requirements: Eligible applicants may request a waiver of governing board requirements. Community Health Center applicants are not eligible. Eligible applicants are organizations seeking support for Migrant Health Centers, Health Care for the Homeless, and Public Housing Primary Care Funding.

Health Center Affiliation Certification: This is a certification of compliance with Department policies when the applicant organization has an arrangement or affiliation with another organization.

Need for Assistance: This form provides information on the proposed service area and target population to determine if the proposed New Access Point will be located a needed area.

Emergency Preparedness: This form is a checklist that provides information on the applicant organization’s emergency preparedness and management plan.

Points of Contact Form: This form provides contact information on the applicant/grant organization.

The following section below describes the revisions from the last clearance package and the purpose for each change made from the current cleared package.

1. The addition of new structured application forms:

The following forms are new forms for this clearance package. In the past, these forms were not provided to applicants in a web based structured format but as open ended narrative with no particular structure or format. These data were collected by the applicants in previous grant application or CIS applications but not in a specific structured form. These were provided to the applicant in a down-loadable format as open ended narratives. They were to be attached to the application request.

The Health Care and Business Plans outline the goals and related performance measures to be accomplished during the project period. The goals and performance measures should be responsive to the identified community health and organizational needs as well as key service delivery activities discussed in the program narrative. The Health Care and Business Plans reflect the cumulative performance goals of the overall organization, even if the applicant has several clinic sites, and/or various activities at multiple sites.

• Health Care Plan (Non – Compete): This form is a combination of a checklist and narratives. This form provides information to program to support the provision of high quality patient care in HRSA-funded health centers. Health Centers are expected to have ongoing quality improvement/assessment programs that include clinical services and quality management. 

• Health Care Plan (Compete): This form is a combination of a checklist and narratives. This form provides information to program to support the provision of high quality patient care in HRSA-funded health centers. Health Centers are expected to have ongoing quality improvement/assessment programs that include clinical services and quality management. 

• Business Plan (Non-Compete): This form is a combination of a checklist and narratives. This form provides information to program to support the provision of high quality patient care in HRSA-funded health centers. Health Centers are expected to have ongoing quality and business program improvement/assessment programs that include clinical services and quality management. 

• Business Plan (Compete): This form is a combination of a checklist and narratives. This form provides information to program to support the provision of high quality patient care in HRSA-funded health centers. Health Centers are expected to have ongoing quality and business program improvement/assessment programs that include clinical services and quality management.

Since all our health centers throughout the nation serve vastly different populations and are located in so many different areas, grantees are encouraged to utilize indicators based on their own performance using the Health Care and Business Plans.  In cases where this information is not available, grantees can base their performance improvement goals on National and State roll-up data when possible. 

Especially for health centers that serve special populations, BPHC is interested in the development of the grantee’s proposed strategies, key action steps and expected impact of those strategies on improving its performance measure rather that productivity and standard benchmarking.  The strategies proposed should intend to address the most important root causes identified and, be geared to having the greatest potential impact on the grantee’s performance measure. As additional BPHC tools and resources are developed, grantees will be able to access performance data from health centers service similar special populations; organization size, patient population size, etc. to create and monitor their performance improvement goals.

Scope of Project: Health center must maintain their funded scope of project (sites, services, service area, target population and providers), including any increases based on recent grant awards. (45 CFR Part 74.25). It defines the activities supported under the total approved section 330-funded related project budget (Federal funds, program income, and other funds). It also broadly defines the scope of Federal Tort Claims Act (FTCA) coverage, site information for 340B Drug Pricing Program, delivery sites and services for State Medicaid Offices to calculate payment rates under PPS, and defines the appropriate delivery sites for CMS to determine eligibility for FQHC Medicare cost-based reimbursement.

The forms provide the Agency/program with an understanding of the impact the scope change will have on their targeted population that they are serving as a part of their 330 Health Center scope of project.

• Check list for Adding a site: this form is a combination of a checklist and narratives. It provides program with an understanding of the impact to the community and the population by the addition of this service site.

• Check List for Deleting a site: this forms is a combination of a checklist and narratives. It provides program with an understanding of the impact to the community and the population by the deletion of this service site.

• Checklist for Adding a service: this form is a combination of a checklist and narratives. It provides program with an understanding of the impact to the community and the population by the addition of the service(s).

• Checklist for Deleting a service: this form is a combination of a checklist and narratives. It provides program with an understanding of the impact to the community and the population by the deletion of the service (s).

• Checklist for Relocating a Site: this form is a combination of a checklist and narratives. It provides program with an understanding of the impact to the community and the population by the relocating of this service site.

Capital Improvement/Investment:

• Capital Improvement/Facility Investment Proposal Cover Page: This form collects information from applicants that addresses how all projects together will address the needs of the community as well as the long-term impact of all projects.  The form also requires applicants to explain how they plan to maintain improved access/services that will result from the project(s) within their existing operational budget/grant support and explain whether and how sustainable design practices will be utilized.

• Capital Improvement/Facility Investment Project Cover: This form requires applicants to present a framework and explanation of all aspects of a specific project, including need, management, implementation plan, timeline and how the funds will be used.

• Capital Improvement/Facility Investment Project Impact: This form captures information on the specific impact of each project, depending on project type.   Measures include increased or improved square footage, both health center and construction full-time equivalents supported by the grant, and HIT/EHR system users.

• Assurances: Obtain assurances from the applicant that the implementation of the proposed facility improvement project will comply with various federal requirements.

• Equipment List: The purchase of any equipment may be an eligible use of grant funding ONLY IN conjunction with an alteration/renovation or construction project. Applicants must provide a detailed equipment list to identify the equipment to be purchased with the Capital Improvement/Facility Investment Project. Any equipment purchased through the FIP project should be pertinent to health center operations and serve an identified user group. Please note that equipment must be maintained, tracked, and disposed of in accordance with 45 CFR Parts 74.34 and 92.32. Applicants must identify the following elements for each piece of equipment to be purchased with Capital Improvement/Facility Investment Project funds; applicants must also include non-expendable supplies that are less than $5,000 to be purchased with FIP funds¹. Equipment type will be categorized as clinical or non-clinical.

Item Description	Unit Price	Quantity	Total Price	Equipment Type

• Other Requirements for Sites: to obtain information on the proposed site regarding ownership, site control, and Historic Preservation issues.

2. This section will identify the specific changes to previously cleared FQHC Application Forms and the justification for the change.

• Organization Contacts Form (previously knows as Points of Contact form):

  • Add the collection of Chief Executive Officer for the organization. We are asking for the name, Business phone number and business email address. An additional point of contact in the Health Center management team is often needed.

• Annual Emergency Preparedness Report Form:

  • This form will now be captured in a structured format, replacing a paper attachment. This will be a web based fill-able form for easier access to the application data for program decision making. As part of converting this form to a structured web based format, we have had to revise the format.

• Need For Assistance Worksheet Form:

  • This form will now be captured in a structured format, replacing a paper attachment. This will be a web based fill-able form for easier access to the application data for program decision making. As part of converting this form to a structured web based format, we have had to revise the format.

• Request for Waiver Governance Requirements From:

  • This form will now be captured in a structured format, replacing a paper attachment. This will be a web based fill-able form for easier access to the application data for program decision making.

• Community Characteristics Form:

  • This form will now be captured in a structured format, replacing a paper attachment. This will be a web based fill-able form for easier access to the application data for program decision making.

• Current Board Member Characteristics Form:

  • This form will now be captured in a structured format, replacing a paper attachment. This will be a web based fill-able form for easier access to the application data for program decision making.

• Health Center Affiliation Certification/Checklist Form:

  • This form will now be captured in a structured format, replacing a paper attachment. This will be a web based fill-able form for easier access to the application data for program decision making.

• Staffing Profile:

  • This form will now be captured in a structured format, replacing a paper attachment. This will be a web based fill-able form for easier access to the application data for program decision making.

  • We have deleted the section titled - Part 1: Non-Federal Share, Program Income; PROJECTED FEE FOR SERVICE INCOME and PROJECTED CAPITATED MANAGED CARE INCOME. This is information that is no longer needed from applicants to make funding decisions.

• Form 1A- General Information Worksheet:

• Business Entity Section: We have added 2 categories; Tribal Entity and Urban Indian so we can identify those Health Center Program Applicants that are Tribal or Urban Indians since they are eligible for Section 330 funding.

• Organization Type Section: This was changed from an open text box to a menu box. The applicant will be able to select all that apply. This will allow program to query the types of Health Center Program organizations.

• Funding Priority Section: This section was changed from an obsolete funding priority for high poverty counties to a funding priority for a target population at or below the federal poverty level.

3. Use of Improved Information Technology

The data collection forms are completed by applicants or grantees using a web based data collection system that is completely integrated with HRSA Electronic Handbooks (EHBs). The HRSA EHB provides authentication and authorization services to all applicants.

Application data can be submitted using standard web browsers through a Section 508 compliant user interface. The system presents users with electronic forms that clearly communicate what is required and provide assistance in completing their applications. Usability features such as those that pre-fill data from prior year applications based on business rules prevent redundant data entry. Users are able to work on the forms in part, save them online and return to complete them later. Programming rules routinely make edit checks to ensure that the data submitted meets the legislative and programmatic requirements. The users are provided with a summary of what is complete and what is incomplete along with links to jump to the appropriate sections to fix the identified incomplete parts.

4. Efforts to Identify Duplication

The applicant organizational information requested in these forms is unique to these Programs and is not available elsewhere.

5. Involvement of Small Entities

This activity does not have a substantial impact on small entities or small businesses.

6. Consequences if Information Were Collected Less Frequently

If the information is not collected annually the Bureau would be unable to make grant awards. The information is also required in order to monitor the progress of the Health Centers to ensure that they are in compliance of the 330 Statue and Program Expectations.

7. Consistency With Guidelines in 5 CFR 1320.5(d)(2)

The data are collected in a manner consistent with guidelines contained in 5 CFR 1320.5(d) (2).

8. Consultation Outside of the Agency

The notice required by 5 CFR 1320.8(d) was published in the Federal Register on March 29, 2010 (Vol. 75, pages 15436). One public comment was received from PEW Children’s Dental Campaign, a campaign of the PEW Center on the States. The comment letter, which was from Shelly Gehshan, Project Director and Kathy Patterson, Senior Officer for Government Relations, requested that HRSA revisit how dental services is listed on Form 5A of the FQHC Application Forms. PEW would like HRSA to expand what is considered required to reflect comprehensive dental services for adults and children, as stated in PIN 2001-18. HRSA recognizes the value of comprehensive oral health services and the relationship between oral health and overall health. Form 5A is not being modified since it reflects the specific language from Section 330 of the Public Health Service Act regarding what is classified as required versus additional services.  No comments were received.

The guidance and applications were provided to the National Association of Community Health Centers (NACHC) for review of the materials regarding clarity and the estimate of annualized burden. The NACHC members consulted were:

Freda Mitchum

National Association of Community Health Centers

202-659-8008

John Ruiz

Health Systems Specialist

National Association of Community Health Centers

202-659-8008

9. Remuneration of Respondents

Respondents will not be remunerated.

10. Assurance of Confidentiality

No assurance of confidentiality is made to the applicants. These applications specify the reporting of aggregate data on users and the services they receive, in addition to descriptive information about each grantee and its operations and financial systems. Grantee level data are covered under the Freedom of Information Act.

11. Questions of a Sensitive Nature

There are no questions of a sensitive nature.

12. Estimates of Annualized Hour Burden

Estimates of annualized reporting burden are as follows:

Type of Application Form	Number of Respondents	Responses per Respondent	Total Responses	Hours per Response	Total Burden Hours
General Information Worksheet	1,034	1	1,034	2.0	2,068
Planning Grant: General Information Worksheet	250	1	250	2.5	625
BPHC Funding Request Summary	1,034	1	1,034	2.0	2,068
Documents on File	1,034	1	1,034	1.0	1,034
Proposed Staff Profile	1,034	1	1,034	2.0	2,068
Income Analysis Form	1,034	1	1,034	5.0	5,170
Community Characteristics	1,034	1	1,034	1.0	1,034
Health Care Plan(Competing)	800	1	800	4.0	3200
Health Care Plan (Non-Competing)	1,034	1	1,034	2.0	2,068
Business Plan (Competing)	800	1	800	4.0	3200
Business Plan (Non-Competing)	1,034	1	1,034	2.0	2,068
Services Provided	1,034	1	1,034	1.0	1,034
Sites Listing	1,034	1	1,034	1.0	1,034
Other Site Activities	700	1	700	0.5	350
Change In Scope (CIS) Site Add Checklist	300	1	300	1.0	300
CIS Site Delete Checklist	200	1	200	1.0	200
CIS Relocation Checklist	200	1	200	1.5	300
CIS Service Add Checklist	100	1	100	1.0	100
CIS Service Delete Checklist	100	1	100	1.0	100
Board Member Characteristics	1,034	1	1,034	1.0	1,034
Request for Waiver of Governance Requirements	150	1	150	1.0	150
Health Center Affiliation Certification	250	1	250	1.0	250
Need for Assistance	900	1	900	3.0	2,700
Emergency Preparedness Form	1,034	1	1,034	1.0	1,034
Points of Contact	800	1	800	0.5	400
Capital Improvement/ Facility Investment Proposal Cover Page	700	1	700	1.0	700
Capital Improvement/ Facility Investment Project Cover	700	1	700	1.0	700
Capital Improvement/ Facility Investment Project Impact	700	1	700	0.5	350
Assurances	900	1	900	.5	450
Equipment List	900	1	900	1.0	900
Other Requirements for Sites	900	1	900	.5	450
Total	1,034	1	22,758		37,139

Basis for the estimates:

The burden estimates for the applications and forms were based on previous experience with these forms, and input from grantees using the EHB system and application forms.

The work can be performed by a senior staff person with an average wage rate of $35 per hour.

13. Estimates of Annualized Cost Burden to Respondents

There are no capital or start up costs for the data collection required to complete these applications and forms.

14. Estimated Cost to the Federal Government

The estimated annual cost to the government is approximately $138,000 (2 GS-12, 1 GS-13, 1 GS-14 FTE’s – 40% time of work) for reviewing the forms, and for processing and providing notification to applicants.

15. Change in Burden

The OMB Inventory currently contains 52,688 burden hours for this activity. This request is for 37,139 total burden hours, for a decrease of 15,549 total annual burden hours.

A part of the change in burden hours is due to program adjustments resulting from a decrease in the estimated number of hours (a decrease of 29,324 total annual hours) per respondent since the last clearance request. There are three major reasons for the decrease on total annual burden hours: 1) The streamlining of these application forms to ensure that health centers are not providing the same information on different forms;

2) The electronic structuring of required application forms; and

3) Further assessment of the previous burden hours showed that the burden was too high based on Health Center feedback.

The change in burden also shows a program change increase of 13,775 annual burden hours due to the addition of new forms, including the Health Care Plan (Competing), Health Care Plan (Non Competing), Business Plan (Competing), Business Plan (Non Competing), Checklist forms for deleting/adding sites and for deleting/adding services, and the Capital Improvement/Investment forms.

Due to the program adjustments and program changes, the net total annual burden for this activity is 37,139 hours.

For this clearance request, each form is being submitted separately to more accurately reflect the number of respondents per form. This results in a large total number of responses as each form is submitted as a single entity. OMB currently approves 15,131 annual responses for 1,021 respondents. This request includes an increase in the number of respondents to 1,034 respondents with a total number of responses of 22,758.

16. Time Schedule, Publication, and Analysis Plans

There will be no statistical analysis done on the information received nor will there be any publication of the information reported on the applications.

17. Exemption for Display of Expiration Date

The expiration date will be displayed.

18. Certifications

This project fully complies with CFR 1320.9. The certifications are included in this package.

1 Certain items of supply individually have a useful life of more than 1 year but generally do not have an acquisition cost greater than $5,000 (e.g., generator and personal computer).

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