Look-Alike Overview and Initial Designation Application Process U.S. Department of Health and Human Services Health Resources and Services Administration Bureau of Primary Health Care February 13, 2013

Agenda Health Center, Look-Alike and FQHC Overview Changes from 2011/2012 Instructions Eligibility Requirements Need, Target Population, and Service Area Operational and Compliant at the Time of Application Services Contracts/Written Agreements Application Process, Components and Submission Preparing a Successful Application Questions and Answers 2

What is a Look-Alike? 3 FQHCs: All health centers in the Health Center Program are eligible to apply to be reimbursed using specific Federally Qualified Health Center (FQHC) payment methodologies. Tribal Organizations Look-alikes are health centers that don’t receive a grant Health Centers Health Center Program

What is an FQHC? A Federally Qualified Health Center (FQHC) is an entity defined under Medicare and Medicaid statutes.* The term “FQHC” is used by CMS to indicate eligibility for reimbursement by Medicare, Medicaid, and CHIP using specific payment methodologies. To be an FQHC, an entity must fall under at least one of the following categories: Meet requirements of the Health Center Program and receive a grant under section 330 of the Public Health Service Act. Meet requirements of the Health Center Program but do not receive a grant under section 330 of the Public Health Service Act. Organizations that qualify as an outpatient health program or facility operated by a tribe or tribal organization.** * Social Security Act §1861(aa)(4)(B) and §1905(l)(2)(B). ** Under the Indian Self-Determination Act or by an Indian organization receiving funds under Title V of the Indian Health Care Improvement Act. 4

Fundamental Principles of Health Centers Private non-profit or public entities that serve a high-need community or population. Governed by a community board; at least a majority must be health center patients who represent the patient population served. Provide comprehensive primary medical care and enabling and supporting services as their primary purpose. Provide services to all, with fees adjusted based upon ability to pay. Collaborate with safety net providers and others (e.g., State and local health departments) in the area. Meet all performance and accountability requirements for administrative, clinical and financial operations. 5

Benefits BenefitApplicable to Look-Alikes Health Center Program grant fundingNO Eligible to apply for Medicaid FQHC Payment Methodologies (Prospective Payment Systems [PPS]) YES Eligible to apply for Medicare FQHC Payment Methodologies YES Access to 340B drug pricingYES Eligible for Federal Tort Claims Act medical malpractice insurance NO Automatic Health Professional Shortage Area (HPSA) Designation YES 6

Highlights of 2013 Changes Guidance for Annual Certification and Renewal of Designation applications will be released separately. HRSA has final authority to designate new and recertify existing look-alikes and to approve change in scope requests. –The Centers for Medicare and Medicaid Services (CMS) will continue to have authority over FQHC payment methodologies and FQHC provider enrollment processes. Applicants must demonstrate the organization has been operational for a minimum of 6 months prior to application submission. Applicants must document that primary medical care is the organization’s primary purpose. Applicants must document that it operates at least one full-time, permanent site. 7

Look-Alike Eligibility Requirements Eligibility Requirements Must be a private, charitable, tax-exempt nonprofit organization OR public entity (direct or co-applicant arrangement). Must serve a currently designated medically underserved area (MUA) or medically underserved population (MUP). Must demonstrate that the organization is not owned, controlled or operated by another entity. Have at least one full-time permanent service delivery site operating at least 40 hours per week. 8

Look-Alike Eligibility Requirements (continued) 9 Eligibility Requirement Must be operational for at least six months prior to application. The primary purpose of the applicant organization must be to provide primary medical care. Applicants must be compliant with all Health Center Program requirements at the time of application.

Documenting Operational Status Applicants must provide the following evidence of operational status: At least 6 months of governing board meeting minutes, demonstrating a compliant board that meets monthly and exercises its required authorities over an operating health center. An independent financial audit or at least 6 months of financial statements that provide sufficient information for the board to exercise associated decision making and which reflect the organizational structure for which look-alike designation is requested. 10

Documenting Operational Status (continued) Billing to Medicaid and Medicare for primary care visits and documentation of current primary care provider numbers. Billing for primary care services using a compliant sliding fee discount scale. The operational period may include time during which the organization is coming into compliance with Health Center Program requirements (e.g., part of the 6 months may include finalizing contracts or formal referral arrangements for required services). 11

Compliance at the Time of Application Applicant must demonstrate full compliance with Health Center Program requirements, at the time of application Need 11 Collaborative Relationships 2 Required and Additional Services 12 Financial Management and Control Policies 3 Staffing 13 Billing and Collections 4 Accessible Hours of Operation/Locations 14 Budget 5 After Hours Coverage 15 Program Data Reporting Systems 6 Hospital Admitting Privileges and Continuum of Care 16 Scope of Project 7 Sliding Fee Discounts 17 Board Authority 8 Quality Improvement/Assurance Plan 18 Board Composition 9 Key Management Staff 19 Conflict of Interest Policy 10 Contractual/Affiliation Agreements

Primary Purpose is Primary Medical Care Primary medical care patient visits for current and projected patients must be at least 50% of the combined visits for all services provided. Primary medical services include basic health services related to family medicine, internal medicine, pediatrics, obstetrics, or gynecology that are furnished by physicians or, where appropriate, mid-level providers. 13

Need for Services Applicants must demonstrate there is sufficient need in the proposed service area to support a new health center. In addition to the conducting a needs assessment and completing the Need for Assistance Worksheet, applicants must: Define a logical service area based on need and organizational capacity. Produce a service area map using HRSA’s UDS Mapper and provide data from the UDS Mapper to support the need for services in the proposed service area. 14

Service Area The service area is the area in which the majority of the organization’s patients reside. When defining a service area, applicants must ensure the following: –Services provided are available and accessible to the residents of the area; –Boundaries of the area conform, to the extent practicable, to relevant boundaries of political subdivisions, school districts, and Federal and State health and social service programs; and –Boundaries eliminate, to the extent possible, barriers to access to the services of the center, including barriers resulting from the area’s physical characteristics, its residential patterns, its economic and social grouping, and available transportation. 15

Target Population A target population is the population to whom the look- alike targets its services. The target population may be a subset of the service area, e.g., all low income residents in the service area, or it may include all residents of the service area, as appropriate. Services must be available to all residents of the service area without regard for ability to pay. 16

Required Services Overview Services Provided Directly by Applicant (Form 5A, Column 1) –Applicant provides the services directly. Services Provided via a Formal Written Contract/Agreement (Form 5A, Column 2) –Applicant pays (and bills) for services provided by individual providers or a provider group under a formal contract/agreement. 17 Services included in the scope of project must be available equally to all, regardless of ability to pay.

Required Services Overview (continued) Formal Written Referral Arrangement/Agreement (Form 5A, Column 3) –Applicant maintains responsibility for the patient’s treatment plan and provides all required preventive, enabling, and additional health services as appropriate and necessary. –The applicant does not pay or bill for the service. –Applicant must describe: How visits will be documented in the patient record; How follow-up care will be assured; and How services will be provided on a sliding fee discount scale. 18

Specialty and Other Services Applicants may not include specialty and other services in the initial designation scope of project. Specialty and other services may be added to the scope of project through a Change in Scope request after look- alike designation. 19

Documenting Contracts and Agreements Attachment 7—Contracts and Affiliation Agreements –Comprehensive account of each contract, agreement and formal referral arrangement. Form 8—Health Center Agreements –All agreements that constitute a substantial portion of the proposed scope of project. –Applicants must attach all contracts in full and summarize them in Attachment 7. 20

Application Process 21

Application Process: Grantee and Look-Alike Comparison GranteeLook-Alike CompetitiveNot competitive Announced application deadlinesRolling Submitted application is finalMay have the opportunity to provide additional information 22

Initial Designation Application Preparation: One Example Assess need for additional primary care services in the community Operate as a primary care provider under governing board’s authority and establish compliance with all Health Center Program Requirements (6 months prior to application submission) Demonstrate full compliance with all Health Center Program requirements Submit initial designation application Address look- alike eligibility requirements as needed Establish a compliant governing board Collaboratively explore options to address unmet needs Develop coordinated plan to establish a new look-alike

Application Review Process Initial Designation Application* HRSA completeness and eligibility review Disapproval and TA HRSA reviews for compliance with all Health Center Program requirements Request for additional information Disapproval HRSA issues Notice of Look- Alike Designation (NLD) Newly designated look-alike applies to CMS and State Medicaid agency for FQHC reimbursement and for other benefits (e.g., 340B drug pricing), as appropriate *Applications must be responsive to the most current Look-Alike Initial Designation Instructions. HRSA will not review applications that are not responsive to the specific requirements for look-alike designation. Additional information submission

Allotted Time for Application Review 25 Responsible Entity Step in ProcessNumber of Days ApplicantDevelopment and submission of application once the application process has been initiated in the EHB. 90 HRSAInitial review of the application once received in the EHB. 90 ApplicantResponse to additional information requested by HRSA (as necessary) HRSAHRSA review of applicant response to additional information and issuance of Notice of Look-Alike Designation or Disapproval. 45 HRSA timeframes are approximate and may vary due to extenuating issues.

Enrolling for FQHC Medicare and Medicaid Reimbursement Look-alike designation establishes eligibility to enroll in Medicare as an FQHC and for enrollment in State Medicaid program as an FQHC provider. Each new look-alike organization should: –Prepare and submit a Medicare enrollment application for each permanent and seasonal site and receive appropriate approvals prior to billing under the FQHC benefit. –Enroll in the state Medicaid program as an FQHC provider. 26

Application Components Program Abstract Program Narrative –Need –Response –Collaboration –Evaluative measures –Resources/capabilities –Governance Forms Other Attachments 27

Required Forms Form 1A: General Information Worksheet Clinical Performance Measures Financial Performance Measures Form 2: Staffing Profile Form 3: Income Analysis Form Form 3A: Look-Alike Budget Form 4: Community Characteristics Form 5A: Services Provided Form 5B: Service Sites Form 5C: Other Activities/Locations (if applicable) Form 6A: Current Board Member Characteristics Form 6B: Request for Waiver of Governance Requirements Form 8: Health Center Agreements Form 9: Need for Assistance Form 10: Annual Emergency Preparedness and Management Report Form 12: Contact Information MS Word versions of all forms are located at /about/lookalike. These forms can be used for planning purposes. However, forms submitted as part of the official application must be completed in the EHB.

Required Attachments Project Abstract Project Narrative Attachment 1: Patient Origin Study Attachment 2: Service Area Map Attachment 3: Current MUA/MUP Designation Attachment 4: Governing Board Bylaws Attachment 5: Governing Board Meeting Minutes Attachment 6: Co-Applicant Agreement for Public Centers (if applicable) Attachment 7: Affiliation, Contract, and/or Referral Agreements (if applicable) Attachment 8: Articles of Incorporation Attachment 9: Evidence of Non-Profit or Public Agency Status Attachment 10: Medicare and Medicaid Provider Documentation Attachment 11: Organizational Chart Attachment 12: Position Descriptions for Key Personnel Attachment 13: Resumes for Key Personnel Attachment 14: Schedule of Discounts/Sliding Fee Scale Attachment 15: Most Recent Independent Financial Audit Attachment 16: Letters of Support Attachment 17: Floor Plans Attachment 18: Other Information

Application Submission Applications must be submitted through the HRSA EHB –Refer to HRSA’s Electronic Submission User Guide, available online at for detailed application and submission instructions. Applicants have a maximum of 90 calendar days to complete an application in the EHB system. HRSA will not review ineligible applications or applications not submitted within 90 calendar days. 30

Preparing a Successful Application Follow all look-alike initial designation application instructions for the Project Narrative and for each required form and attachment. Ensure that information is consistent across forms, attachments, and the Project Narrative. Demonstrate clearly and thoroughly how the organization has been operational (e.g., providing primary health care services in its current organizational structure, under a compliant governing board) for at least 6 months. Demonstrate clearly and thoroughly how the organization currently meets all Health Center Program requirements. Program requirements are located at

Preparing a Successful Application (continued) Ensure that all contracts and affiliation agreements comply with HRSA policy. Develop time-framed and realistic clinical and financial performance measure goals. Identify a logical service area based on need. Provide a service area map using HRSA’s UDS Mapper and indicate the locations of all other safety net providers. –See and go to How to Create a Service Area Map and Data Tablehttp:// 32

Preparing a Successful Application Request assistance from your primary care association, state primary care office, and other HRSA partners. A list of HRSA partners is located at: Consult BPHC Policy Information Notices (PINs) and Program Assistance Letters (PALs) for guidance as needed. PINs and PALs are located at:

Pursue collaboration with all health centers (grantees and look-alikes) and other safety net providers in and adjoining your service area. Consult PIN : Service Area Overlap, Policy and Process located at: 09.html html Provide letters of support from health centers and others (e.g., other safety net providers, State and local health departments) in your service area. 34

Questions 35

Technical Assistance HRSA Partner Links (Primary Care Associations, Primary Care Offices, National Cooperative Agreements) Office of Policy and Program Development Instructions and TA: Telephone: (301)