Supporting Statement

5/8/2013

Supporting Statement

The Health Center Program 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, Health Center Program Application Forms, and the current expiration date is October 31, 2013.

These forms are used to request funding under Section 330 of the Public Health Service (PHS) Act, as amended; change their scope of project and become designated as Look-Alikes. The revisions include the addition of eleven forms and some minor changes to previously approved forms. All revisions are documented below.

Health centers (section 330 and Look-Alikes) deliver comprehensive, high quality, cost-effective primary health care to patients regardless of their ability to pay. During that time, health centers have become the essential primary care provider for America’s most vulnerable populations. Health centers advance the preventive and primary medical/health care home model of coordinated, comprehensive, and patient-centered care, coordinating a wide range of medical, dental, behavioral, and social services. More than 1,200 health centers operate nearly 9,000 service delivery sites that provide care in every U.S. State, the District of Columbia, Puerto Rico, the U.S. Virgin Islands, and the Pacific Basin.

BPHC program-specific forms are critical to the Health Center Program grant and non-grant award process. In addition, the forms are used for program oversight and monitoring activities. The activities using these forms are as follows: New Access Points (NAP), Service Area Competition (SAC), Non-Competing Continuation, Expanded Medical Capacity (EMC), Service Expansion (SerXP), Look-Alike Applications, Changes in Scope (CIS), Increased Demand for Services (IDS), Outreach and Enrollment (O&E), Capital Development, Health Center Planning, Primary Care Associations (PCA), National Cooperative Agreements, Native Hawaiian Health Care Improvement and Quality Improvement programs.

2. Purpose and Use of Information

The purpose of these forms is to provide information to HRSA staff and objective review committee panels for application evaluation, funding recommendation & approval, designation and program oversight. Health centers will use a combination of the application forms to apply for one or more of the following various opportunities:

• NAP is a competitive application to receive support for new delivery sites to provide comprehensive primary and preventive health care services. NAPs can be either new starts that do not currently receive Health Center Program funding under section 330, or satellite sites of existing 330 health center organizations.

• SAC is a competitive application for existing and new Health Center organizations to receive Federal financial assistance to support comprehensive primary health care services for an announced underserved service area.

• EMC is a competitive application for funds to support expanding the medical capacity at sites currently operated by health center organizations receiving support under the Health Center Program. EMC funding 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 is a competitive opportunity to support the expansion or enhancement of services in mental health/substance abuse, oral health, vision screening and comprehensive pharmacy services.

• Non-Competing Continuations are progress reports from Health Center Program grantees to ensure they are meeting program requirements and expectations.

• IDS is a request 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.

• O&E is an application to expand current outreach and enrollment assistance activities and facilitate enrollment of eligible health center patients and service area residents into affordable health insurance coverage.

• Capital Development funding opportunities provide funding for construction, renovation, repair and/or improvement of health center service delivery sites.

• Health Center Planning opportunity provides support to organizations that are in the planning and development stages for a comprehensive primary care health center. 

• PCA cooperative agreements with state and regional organizations provide training and technical assistance (T/TA) to potential and existing health centers.

• National Cooperative Agreements provide national T/TA to potential and existing section 330 funded health centers with the goal of assisting them to meet program requirements, improve performance, and support program development and analysis activities.

• Native Hawaiian Health Care Improvement is a Congressional Special Initiative in support of the Native Hawaiian Health Care Systems (NHHCS) to improve the provision of comprehensive disease prevention, health promotion, and primary care services to Native Hawaiians.

• Quality Improvement Supplemental funding supports quality of care, access to services, and reimbursement opportunities for health centers by supporting the costs associated with enhancing quality improvement systems and becoming patient-centered medical homes (PCMH).

• CIS requests are submitted by existing health centers to change the current approved scope of project as they relate to services offered, sites, and other scope activities that require prior approval by HRSA.

• Look-Alike applications support organizations seeking initial designation or re-certification or renewal as a Look-Alike. Look-Alikes must meet all eligibility requirements of a Section 330 grant, but they do not receive Section 330 grant funds.

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

• Form 1A: General Information Worksheet: This form collects summary information on the applicant organization and the proposed project including specific applicant information, the proposed service area, target population, service providers, and patient and visit projections.

• Form 1B: BPHC Funding Request Summary: This form collects program specific project budget estimates.

• Form 1C: Documents on File: This form collects the date of the last review or revision of key documents used by the health center governing board and staff for ensuring compliance with Health Center Program requirements.

• Form 2: Staffing Profile: This form identifies the total personnel and number of FTEs for the proposed project.

• Form 3: Income Analysis: This form identifies the estimated non-Federal revenues (all other sources of income aside from the section 330 grant funds) for the requested budget.

• Form 4: Community Characteristics: This form identifies service area and target population data.

• Form 5A: Services Provided: This form identifies the mode of service provision for all clinical and non-clinical services.

• Form 5B: Service Sites: This form collects information on the site location including address, contact information, and site characteristics (e.g., zip codes from which the majority of the patients will come to the site, hours of operation).

• Form 5C: Other Activities/Locations: This form collects information on activities provided at a location other than a service site.

• Form 6A: Current Board Member Characteristics: This form collects information on board members, including areas of expertise, years of service on the board, and demographics.

• Form 6B: Request for Waiver of Governance Requirements: This form is used to request a waiver of governing board requirements. Only organizations seeking support for Migrant Health Centers, Health Care for the Homeless, and Public Housing Primary Care may request a waiver.

• Form 8: Health Center Agreements: This form identifies when the applicant organization has an agreement with another organization to carry out a substantial portion of the proposed scope of project and ensures compliance with governance requirements.

• Form 9: Need for Assistance Worksheet: This form collects specific data on core barriers to health care and other health and access indicators that determine the level of need in the proposed service area and target population.

• Form 10: Annual Emergency Preparedness Report: This form is a checklist that collects information on the applicant organization’s emergency preparedness and management plan.

• Form 12: Organization Contacts: This form collects contact information for the Chief Executive Officer, Contact Person, Medical Director, and Dental Director of the organization.

• Clinical Performance Measures (formerly Health Care Plan): This form collects information on specific clinical performance measures to be accomplished during the project period, including goals, baselines, methodology, key contributing and restricting factors, and major planned actions.

• Financial Performance Measures (formerly Business Plan): This form collects information on specific financial performance measures to be accomplished during the project period, including goals, baselines, methodology, key contributing and restricting factors, and major planned actions.

• Check list for Adding a New Service Delivery 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 Existing Service Delivery 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 deletion of this service site.

• Checklist for Adding New 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 Existing 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.

• Checklist for Replacing Existing Service Delivery 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 replacing this service site.

• Proposal Cover Page: This form collects information from applicants that address 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.

• Project Cover Page: This form requires applicants to present a framework and explanation of all aspects of a specific project, including a detailed project description, need, management, response, timeline and how the funds will be used.

• Equipment List: Applicants must provide a detailed equipment list to identify the equipment to be purchased with the Capital Development funding. Equipment type will be categorized as clinical or non-clinical.

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

The following section below describes the revisions from the last clearance package:

1. The addition of new structured and non-structured application forms:

The following forms are new forms for this clearance package.

• Checklist for Adding a New Target Population: this form is a combination of a checklist and narratives. It provides program with an understanding of the impact to the community and the existing target population by the addition of the new target population.

• Increased Demand for Services (IDS): This form collects information from applicants regarding how funding will be used to increase the number of total patients and uninsured patients served. Applicants will also describe the strategies to expand such as, adding new providers, expanding hours of operations, and/or expanding existing health center services.

• Funding Sources: This form identifies other sources of funding that will be necessary to fund the overall project proposal.

• Project Qualification Criteria: This form requires applicants to specifically address eligibility criteria identified in the funding opportunity.

• Implementation Plan: This form collects goals, action steps, focus areas, and related information to demonstrate that the applicant will be operational and compliant with Health Center Program requirements (for NAP and SAC).

• Project Work Plan: This form collects goals, activities, focus areas, and related information to demonstrate that the applicant will provide training and technical assistance in accordance with the Health Center Program requirements (for PCA and NCA).

• Verification Checklist: This form collects responses from applicants regarding their ability to implement a previously submitted application proposal.

• EHR Readiness Checklist: This form collects responses from applicants regarding their readiness to implement a certified EHR system.

• Look-Alike Budget: This form collects projected expenses and revenues.

• O&E Supplemental form: This form collects information from applicants regarding how funding will be used to increase the number of individuals assisted, enrollees and FTEs. Applicants will also describe the strategies to implement O&E activities.

• O&E Progress Report: This form collects performance information related to progress on O&E grants, including individuals assisted, individuals enrolled, FTEs.

• Supplemental Line item budget: This form collects federal and non-federal funding expenses by categories. Starting in FY 2015 the SF424 will be updated to capture these data.

2. This section will identify the specific changes to previously cleared Health Center Program Forms and the justification for the change.

• Form 1B: Added check boxes indicating one-time funding requested.

• Form 1C: Text changes – Added corresponding program requirement to list of documents.

• Form 2: Added column for total federal support requested.

• Form 3: Revised to simplify reporting of projected income and patients.

• Form 4: Text changes – changed from “refused to report” to “declined to report” and consolidated Medicaid option.

• Form 5A: Deleted HIV testing and Hepatitis C Screening, because they are included in Communicable Diseases Screening.

• Form 6A: Text changes – added unreported/declined to report option for gender, ethnicity, and race categories.

• Form 8: Changed to clarify questions and streamline governance checklist.

• Form 9: Text changes – changed “Methodology Utilized/Data Souce Description/Other” to “Methodology Utilized/Extrapolation method.”

• Clinical Performance Measures (formerly Health Care Plan): Text changes to some numerator, denominator, and performance measure descriptions. Added performance measures for Weight Assessment and Counseling for Children and Adolescents, Adult Weight Screening and Follow-up, Tobacco Use Assessment, Tobacco Cessation Counseling, Asthma – Pharmacological Therapy, Coronary Artery Disease, Ischemic Vascular Disease, and Colorectal Cancer.

• Check list for Adding a New Service Delivery Site: changes provide greater clarity of review criteria that must be addressed, ensure appropriateness and completeness of the CIS initial submission, and reduce the need for additional information.

• Check List for Deleting Existing Service Delivery Site: changes provide greater clarity of review criteria that must be addressed, ensure appropriateness and completeness of the CIS initial submission, and reduce the need for additional information

• Checklist for Adding New Service: changes provide greater clarity of review criteria that must be addressed, ensure appropriateness and completeness of the CIS initial submission, and reduce the need for additional information

• Checklist for Deleting Existing Service: changes provide greater clarity of review criteria that must be addressed, ensure appropriateness and completeness of the CIS initial submission, and reduce the need for additional information1

• Checklist for Replacing Existing Service Delivery 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 replacing this service site.

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-populate 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 information requested in these forms is unique to these Programs and is not captured 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 with Section 330 Statue and Health Center 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). 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:

National Association of Community Health Centers

202-659-8008

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
Form 1A: General Information Worksheet	1,700	1	1,700	2.0	3,400
Form 1B: BPHC Funding Request Summary	400	1	400	1.0	400
Form 1C: Documents on File	650	1	650	1.0	650
Form 2: Staffing Profile	1,600	1	1,600	2.0	3,200
Form 3: Income Analysis	1,600	1	1,600	3.0	4,800
Form 4: Community Characteristics	650	1	650	1.0	650
Form 5A: Services Provided	1,600	1	1,600	1.0	1,600
Form 5B: Service Sites	1,600	1	1,600	1.0	1,600
Form 5C: Other Activities/Locations	1,600	1	1,600	0.5	800
Form 6A: Current Board Member Characteristics	1,600	1	1,600	1.0	1,600
Form 6B: Request for Waiver of Governance Requirements	150	1	150	1.0	150
Form 8: Health Center Agreements	250	1	250	1.0	250
Form 9: Need for Assistance Worksheet	650	1	650	5.0	3,250
Form 10: Annual Emergency Preparedness Report	1,600	1	1,600	1.0	1,600
Form 12: Organization Contacts	1,600	1	1,600	0.5	800
Clinical Performance Measures	1,600	1	1,600	2	3,200
Financial Performance Measures	1,600	1	1,600	1	1,600
Checklist for Adding a New Service Delivery Site	700	1	700	2.0	1,400
Checklist for Deleting Existing Service Delivery Site	700	1	700	2.0	1,400
Checklist for Adding New Service	700	1	700	2.0	1,400
Checklist for Deleting Existing Service	700	1	700	2.0	1,400
Checklist for Replacing Existing Service Delivery Site	700	1	700	2.0	1,400
Proposal Cover Page	400	1	400	1.0	400
Project Cover Page	400	1	400	1.0	400
Equipment List	400	1	400	1.0	400
Other Requirements for Sites	400	1	400	0.5	200
Checklist for Adding a New Target Population	50	1	50	1.0	50
Increased Demand for Services	1,200	1	1,200	1	1,200
Funding Sources	400	1	400	0.5	200
Project Qualification Criteria	400	1	400	1.0	400
Implementation Plan	400	1	400	3.0	1,200
Project Work Plan	100	1	100	4.0	400
Verification Checklist	200	1	200	0.5	100
EHR Readiness Checklist	50	1	50	0.5	25
Look Alike Budget	100	1	100	1.0	100
O&E Supplemental	1,200	1	1,200	1.0	1,200
O&E Progress Report	1,200	1	1,200	1.0	1,200
Supplemental Line Item Budget	1,600	1	1,600	0.5	800
Total	1,500	1	32,450		44,825

Note: The above burden table has revised from the 60 day FRN to reflect recent programmatic updates.

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. With a total of 44,825 estimated burden hours, the resulting total projected cost is $1,568,875.

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 40,161 burden hours for this activity. This request is for 44,825 total burden hours, for an increase of 4,664 hours. The increase is due to program adjustments resulting from an increase in the number of health center organizations. In addition, the number of programs using forms has increased due to Congressional direction and the needs of health centers nationally.

For this clearance request, each form is being submitted separately to 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 23,976 annual responses for 1,138 respondents. This request includes an increase in the number of respondents to 1,500 respondents with a total number of responses of 32,450.

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.

29