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COMPLIANCE PLAN DEVELOPMENT

FQHC Conditions for Coverage Questionnaire

This questionnaire is designed to assure that Program meets all of CMS’s Conditions for Coverage (“CfCs”), which are the requirements that an FQHC must meet in order to qualify for Medicare reimbursement. The CfCs are located at 42 C.F.R. 491, et seq. and their criteria are further delineated in the Policy Information Notices (PINs) issued by HRSA which further delineate the CfCs. In some cases, the CfCs requirements are not expressly defined, but subjective goals towards which you must endeavor. In the questionnaire below, I have described the “standard” for each of the CfCs, whether it be expressly-defined or subjective. The questions that appear below each standard are the crtieria that HRSA will examine – as indicated in the CfCs themselves and the PINs – in determining whether a particular standard has been met.

I. NEEDS ASSESSMENT

a. Overview.

i. All FQHCs must assess, document, and be capable of demonstrating the needs of its target population and therefore must have up-to-date information on what their services areas area and the needs of the individuals in those services areas.

b. Questions

i. Do you perform written needs assessments?

A. If so who performs them?

B. How often?

C. Using what data?

ii. Do you have a defined service area?

iii. Is it consistent with the patient origin data in the HRSA Uniform Data System (UDS)?

iv. Do you maintain the following documents?

A. Need assessments?

B. Service area map?

C. UDS patient origin data?

D. List of sites with service area zip codes?

II. SERVICES

a. Overview

i. This section addresses the services and extent of care the FQHC must provide, the staffing required to provide those services and care, and the FQHC’s obligation to assess and improve the quality of those services and care.

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ii. Questions generally applicable to this section:

A. Do you maintain the following documents?

1. Official scope of project for services;

2. Clinical practices protocols and/or related policies and/or procedures governing its delivery of services?

3. Contracts, Memoranda of Agreement/Understanding, etc. for services provided via formal written agreements and/or formal written referral arrangements?

b. Required and Additional Services

i. Standard

A. An FQHC must provide all required primary, preventive, enabling health services and additional health services as appropriate and necessary, either directly or through established written arrangements and referrals.

B. Questions

1. What services are you required to provide? This information will be located in Program’s Form 5A

2. Which of these services do you provide directly?

3. For services provided indirectly, do you have formal written agreements or formal written referral agreements in place for these services?

4. Do the formal written agreements address the following?

a. How the service will be documented in your patient’s record?

b. How you will pay and/or bill for the service; and

c. How your policies and/or procedures will apply?

5. Do the formal written referral agreements address the following?

a. The manner by which the referral will be made and managed, and the process for referring patients back to you for appropriate follow-up care?

b. Whether the referred service is available equally to all health center patients? Note: The referred service must be available equally, but not necessarily via the same referral provider.

c. Do you provide tracking and follow-up care for referred patients?

6. Do you have procedures in place to deal with individuals with limited English proficiency and/or disabilities?

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a. Are interpretation/translation service(s) provided that are appropriate and timely for the size/needs of your patient population (e.g., bilingual providers, onsite interpreter, language telephone line)?

b. Are auxiliary aids and services readily available and responsive to the needs of patients with disabilities (e.g., sign language interpreters, TTY lines)?

c. Are documents or messages vital to a patient’s ability to access your services (e.g., registration forms, sliding fee discount schedule, after hours coverage instructions, signage) provided to patients in the appropriate languages, literacy levels, and/or alternative formats (for patients with disabilities), and in a timely manner?

d. Are patients made aware of these resources? If so, how?

c. Staffing

i. Standard

A. An FQHC must maintain a core staff as necessary to carry out all required primary, preventive, enabling health services and additional health services as appropriate and necessary, either directly or through established arrangements and referrals. Staff must be appropriately licensed, credentialed and privileged.

ii. Questions

A. Are all of your providers, whether employees, contractors, volunteers, or locum tenens, appropriately licensed or certified to perform the activities and procedures detailed within your approved scope of project?

B. Do your written, board-approved credentialing and privileging policies and/or supporting operating procedures meet or address all of the following requirements?

1. Do your credentialing/privileging policy follow one of the following required methods?

a. Ultimate approval authority for credentialing and privileging is vested in the governing board which may review recommendations from either the Clinical Director or a joint recommendation of the medical staff and the CEO.

b. The governing board delegates this responsibility (via resolution or bylaws) to an appropriate individual to be implemented based on board- approved policies and/or related operating procedures (including methods to assess compliance with these policies and/or procedures).

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2. Do your verification policies procedures comply with the following listed in the table below?

Note: HRSA contemplates two types of verification: primary source and secondary source.

a. Primary source verification (“PSV”) is verification by the original source of a specific credential to determine the accuracy of a qualification reported by a practitioner, e.g. director correspondence, telephone/internet verification, reports from credentials verification organizations, or databases such as the American Medical Association Masterfile, American Board of Medical Specialists, etc.

b. Secondary source verification (“SSV”) is verification by anything other than primary sources, such as the original credential, a notarized copy of the credential, or a copy of an original approved by FQHC staff

Credentialing or Privileging Activity

Licensed Independent Practitioner, e.g. physician, dentist, PA, NP

Other e.g. RN, LPN, certified medical assistant

Credentialing

Verification of licensure, registration, or certification

Primary source Primary source

Verification of education Primary source Secondary source

Verification of training Primary source Secondary source

Verification of current competence

Primary source, written Supervisory evaluation per job description

Health fitness (ability to perform the requested privileges) Confirmed statement

Supervisory evaluation per job description

Approval authority Governing body or other appropriate individual

(usually concurrent with privileging)

Supervisory function per job description

Government issued picture identification

Secondary source Secondary source

Immunization and PPD status


Life support training (if applicable)


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Drug Enforcement Administration (DEA) registration

Secondary source, if applicable


Hospital admitting privileges



Initial Granting Of Privileges

Verification of current competence to provide services specific to each of the organization’s care delivery settings

Primary source, based on peer review and/or performance improvement data



(usually concurrent with credentialing)


Renewal or revision of privileges

Frequency At least every 2 years At least every 2 years

Verification of current licensure, registration, or certification

Primary source Primary source

Verification of current competence

Primary source based on peer review and/or performance improvement data



Supervisory function per job description

Appeal to discontinue appointment or deny clinical privileges

Process required Organization option

C. Do you maintain the following documents which are necessary to appropriately document the adequacy of your staffing?

1. Staffing Profile

2. Provider contracts, agreements, and any subrecipient arrangements related to staffing (if applicable)

3. Credentialing and privileging policies and/or procedures

4. Documentation of provider licensure or certification for all licensed or certified health center practitioners

5. Privileging list

d. Hours of Operation, Locations & After Hours Emergency Care

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i. Standard

A. An FHQC must provide services at times and locations that assure accessibility and meet the needs of the population to be served, including providing professional coverage for medical emergencies during hours when the center is closed.

ii. Questions

A. Are the times that services are provided at sites reasonably appropriate to ensure access for the population to be served?

B. Are the locations at which services are provided accessible to the population to be served?

C. Is professional coverage for medical emergencies available to your patients after the center's regularly scheduled hours through clearly defined arrangements?

D. Are patients made aware of the availability of, and procedures for, accessing professional coverage after hours?

e. Continuum of Care

i. Standard

A. An FQHC’s physicians must have admitting privileges at one or more referral hospitals, or other such arrangement to ensure continuity of care. In cases where hospital arrangements (including admitting privileges and membership) are not possible, an FQHC must firmly establish arrangements for hospitalization, discharge planning, and patient tracking.

ii. Questions

A. Do you have arrangements for the hospitalization of your patients as needed (e.g., labor and delivery, emergencies, children, adults)?

1. Note: This may be accomplished either by the your own providers having admitting privileges at one or more hospitals, and/or by you having hospital admitting arrangements with non-health center providers (e.g., hospital, hospitalists, group practices).

B. Do you have internal policies, systems, or procedures addressing hospitalization/emergency department referrals, discharge follow-up, and patient tracking (e.g., tracking laboratory and radiology results not available at the time of discharge) to assure continuity of care for hospitalized patients?

C. If the non-health center providers care for your patients during hospitalization, do you have firmly established arrangements that address hospitalization, discharge planning, and patient tracking in order to assure appropriate

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communication and continuity of care between you and the non-health center providers?

f. Sliding Fee Services

i. StandardA. An FQHC must have a system in place to determine eligibility for patient

discounts adjusted on the basis of the patient’s ability to pay.ii. Questions

A. Are the following areas of the sliding fee discount program addressed in written board-approved policies and/or supporting operating procedures?1. Definitions of income and family size

2. Eligibility for sliding fee discounts based on income and family size for all patients and no other factors

3. Methods for making patients aware of the availability of sliding fee discounts that are effective and appropriate for the language and literacy levels of the patient population

4. Specific structure of all sliding fee discount schedule(s) (SFDS) (Please assess structural requirements based on the criteria below.)

5. Has the sliding fee discount program been evaluated, or is there a plan to ensure it will be evaluated, at least once every 3 years from the perspective of reducing patient financial barriers to care

B. Do you have a sliding fee discount system (SFDS) in place to adjust fees on the basis of the patient’s ability to pay that include the following?1. The income/family size figures reflect the current Federal Poverty

Guidelines (FPG)2. Adjusts fees for individuals and families with incomes above 100% of

the FPG and at or below 200% of the FPG using at least three discount pay classes and ensures no discounts are given to individuals or families with incomes above 200% of the FPG.

3. A full is discount provided for individuals and families with annual incomes at or below 100% of the FPG, unless you specifically elect to have a nominal charge?

4. If you have a nominal charge, is it:

a. Nominal from the perspective of the patient (e.g., based input from patient focus groups, patient surveys)?

b. A fixed fee (not a percentage of the actual charge/cost) that does not reflect the true cost of the service(s) being provided?

c. Not more than the fee paid by a patient in the first SFDS pay class above 100 percent of the FPG?

C. Are all required and additional services within your scope of project available to your patients regardless of ability to pay through a sliding fee

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discount program?a. Are sliding fee discounts applied to all services within your approved

scope of project for which there is an established charge, regardless of the service type (required or additional) or mode of delivery (direct, by contract, or by formal referral agreement?

b. For services provided directly, are all of the services for which there is an established charge, discounted in accordance with the health center’s SFDS?

c. For services provided via formal written agreement, does the written agreement describe how contracted services provided to your patients will be discounted in accordance with an SFDS that meets the SFDS discussed under bulletpoint (B) above?

d. For services provided via formal written referral arrangements, is the referred service discounted for your patients in accordance with the SFDS meeting bulletpoint (B)’s criteria or in a manner that provides greater discounts on the conditions that (1) all your patients at or below 200% of the FPG receive a greater discount for these services than if your SFDS were applied to the referral provider’s fee schedule; and (2) patients at or below 100% of the FPG receive no charge or only a nominal charge for these services.

D. Does the system ensure the following?1. A full discount to individuals and families with annual incomes at or

below100% of the Federal poverty guidelines (only nominal fees may be charged) and for those with incomes between 100% and 200% of poverty, fees must be charged in accordance with a sliding discount policy based on family size and income.

2. No discounts may be provided to patients with incomes over 200 % of the Federal poverty guidelines.

3. No patient will be denied health care services due to an individual’s inability to pay for such services by the health center, assuring that any fees or payments required by the center for such services will be reduced or waived.

E. Do you assess all patients for eligibility for sliding fee discounts, and apply discounts accordingly?

1. Are all patients assessed for income and family size (unless the patient declines/refuses to be assessed)?

2. Are all patients informed of their eligibility for sliding fee discounts?

3. Are all insured patients that are eligible for the SFDS, charged no more than they would have owed under the SFDS? If not, can/do you document that it is subject to limitations on further discounting amounts required by the insurer due to applicable Federal and State law for Medicare and Medicaid and/or terms and conditions of private payor contracts?

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g. Quality Improvement/Assurance Plan

i. Standard

A. An FQHC must have an ongoing Quality Improvement/Quality Assurance (QI/QA) program that includes clinical services and management, and that maintains the confidentiality of patient records.

ii. Questions

A. Do you have a QI/QA program in place, and if so, does it include/address all of the following? 1. Clinical and management services2. A clinical director whose primary responsibility is to carry out the QI/QA

program3. Periodic assessment of the appropriateness of the utilization and quality of

services and the quality of services provided that is:

a. Conducted by physicians or by other licensed health professionals under the supervision of physicians;*

b. Based on the systematic collection and evaluation of patient records; and

c. Identifies and documents the necessity for change in the provision of services and results in the institution of such change, where indicated, i.e. results are shared or reviewed by key management staff and reported to the governing board on a regular basis?

4. Confidentiality of patient records including medical records policies and procedures that address the following areas:

a. Establishing and maintaining a clinical record for every patient receiving care,

b. HIPAA Privacy and Confidentiality

c. Procedures to enable patients to give consent for release of medical record information, and

d. Security of current and archived medical record information?

III.MANAGEMENT AND FINANCE

a. Key Management Staff

i. Standard

A. An FQHC must maintain a fully staffed health center management team as appropriate for the size and needs of the center. Prior approval by HRSA of a change in the Project Director/Executive Director/CEO position is required.

ii. Questions

A. Do you have a CEO or Executive Director/Project Director

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B. Is the key management in terms of size and composition appropriate for your size and needs?

C. Is the team fully staffed with each of the key management positions listed your most recent organizational chart and/or staffing profile filled as appropriate? If not, are you actively recruiting for the vacancy and/or implementing interim measures to address the key management capacity roles?

D. Do you maintain the following documents?

1. Org charts

2. Key management staff position descriptions and biographical sketches

3. Key management vacancy announcements

b. Contractual/Affiliation Agreements

i. Standard

A. An FQHC must exercise appropriate oversight and authority over all contracted services, including assuring that any subrecipient(s) meets its requirements

ii. Questions

A. Do you have written board-approved policies and supporting operating procedures that ensure appropriate procurement and oversight over all contracted services and/or subrecipients, including provisions for the monitoring and evaluation of contractor and/or subrecipient performance?

B. Are appropriate provisions in place to assure that none of the contracts or affiliation agreements have the potential to

1. Limit your authority?

2. Compromise your compliance with Health Center Program requirements in terms of corporate structure, governance, management, finance, health services, and/or clinical operations?

C. Do you maintain the following documents?

1. Contracts or sub-awards

2. Memoranda of Understanding

3. Contracts with another organization for core primary care providers

4. Contracts with another organization for staffing the health center including any contracted key management staff (e.g., CEO, CMO, CFO)

5. Any other key affiliation agreements, if applicable

6. Procurement and/or other policies and/or procedures that support oversight of contracts or affiliations

c. Collaborative Relationships

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i. Standard

A. An FQHC must endeavor to establish and maintain collaborative relationships with other health care providers, including other health centers, in the service area of the center.

ii. Questions

A. Do you work to establish and maintain collaborative relationships (formal and/or informal) with other health care providers in its service area including?

1. Health centers (Health Center Program grantees and look- alikes)

2. Rural health clinics

3. Critical access hospitals

4. Health departments

5. Other major private provider groups serving low income and/or uninsured populations

d. Financial Management

i. Standard

A. An FQHC must maintain accounting and internal control systems appropriate to the size and complexity of the organization reflecting Generally Accepted Accounting Principles (GAAP) and separates functions appropriate to organizational size to safeguard assets and maintain financial stability.

B. An FQHC must assure an annual independent financial audit is performed in accordance with Federal audit requirements, including submission of a corrective action plan addressing all findings, questioned costs, reportable conditions, and material weaknesses cited in the Audit Report.

ii. Questions

A. Do/are your accounting and internal control systems?

1. Appropriate to the organization's size and complexity? Specifically, does the health center’s accounting system provide for

a. Separate identification of Federal and non-Federal transactions, and

b. A chart of accounts that reflects the general ledger accounts.

2. Reflective of GAAP, including accumulation of costs?

3. Designed to separate functions in a manner appropriate to the organization’s size in order to safeguard assets? To maintain financial stability?

B. Do you ensure that:

1. A financial audit is performed annually, in accordance with Federal requirements, including if applicable, the A-133 Compliance Supplement?

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2. A corrective action plan addressing all findings, questioned costs, reportable conditions, and material weaknesses cited in the Audit Report is submitted.

3. The corrective action plan addresses all previous findings, questioned costs, reportable conditions, and material weaknesses found in the Audit Report?

e. Billing and Collections

i. Standard

A. An FQHC must have systems in place to maximize collections and reimbursement for its costs in providing health services, including written billing, credit and collection policies and procedures.

ii. Questions

A. Do you have documentation of participation in Medicaid and the Children’s Health Insurance Program (CHIP)?

B. Do you make reasonable efforts to collect appropriate reimbursement from Medicare, Medicaid, CHIP, Marketplace qualified health plans, and any other public assistance programs, and private third party payors that are available to your patients?

C. Do you make reasonable efforts to secure payment from patients for amounts owed for services in a manner that does not create barriers to care?

D. Do you have written, board-approved policies and supporting operating procedures for billing and collections, including, but not limited to:

1. Provisions for waiving charges that identify circumstances with specified criteria for when charges will be waived, and specific staff with the authority to approve the waiving of charges?

2. If you have “refusal to pay” policies, do these policies or supporting operating procedures define:

a. What constitutes “refusal to pay”?

b. What individual circumstances are to be considered in making such determinations?

c. What collection efforts/enforcement steps are to be taken when these situations occur (e.g., offering grace periods, establishing payment plans, meetings with a financial counselor)?

f. Budget

i. Standard

A. An FQHC must develop a budget that reflects the costs of operations, expenses, and revenues (including the Federal grant) necessary to accomplish the service delivery plan, including the number of patients to be served.

ii. Questions

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A. Do you maintain an annual total budget/operational budget that reflects expenses and revenues (including the Federal grant, as applicable) necessary to accomplish the service delivery plan?

B. Does the budget include projections for all revenue sources to support the scope of project, including fees, premiums, and third-party reimbursements reasonably expected to be received to support operations, and State, local, private and other operational funding?

C. If applicable, are there budgetary controls in effect (e.g., comparison of budget with actual expenditures on a monthly basis) to preclude drawing down Federal funds in excess of:

1. Total funds authorized on the Notice of Award?

2. Total funds available for any cost category, if restricted, on the Notice of Award?

g. Program Data Reporting Systems

i. Standard

A. An FQHC must have systems that accurately collect and organize data for program reporting and which support management decision-making.

ii. Questions

A. Do you have appropriate systems and capacity in place for collecting and organizing the data required for UDS, FFR, Clinical and Financial Performance Measures (submitted with the annual renewal applications), and any other Health Center Program reporting requirements (e.g., those necessary for supplemental funding)?

B. Is information from your data reporting and needs assessments used to inform and support management decision- making?

C. Do you maintain the following documents or records?

1. UDS reports and UDS Health Center Trend Reports

2. Clinical and Financial Performance Measures Forms

3. Clinical and financial information systems (e.g., EHR, practice management systems, billing systems)

h. Scope of Project

i. Standard

A. An FQHC must maintain its funded scope of project (sites, services, service area, target population, and providers), including any increases based on recent grant awards.

ii. Questions

A. Are the following consistent with the scope of project?

1. Number of locations

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2. Specialty services provided

3. Formal agreements are in place for non-direct services

IV. GOVERNANCE

a. Board Authority

i. Standard

A. An FQHC’s Board must perform all of the tasks listed in the questions below?

ii. Questions

A. Does your governing board (Note: all the tasks below must be recorded and verifiable in the board minutes)

1. Hold monthly meetings

a. Does it maintain minutes/records of the meetings?

2. Approve your grant application and budget?

a. Approve the applications, including grants/designation applications and other HRSA requests regarding scope of project?

b. Approve the annual budget and audit?

3. Select/dismiss and evaluate your CEO

4. Select the services to be provided and the health center hours and locations of operations and ensure that its selections are appropriate to meet the needs of the community?

5. Measure and evaluate your progress in meeting your annual and long-term programmatic and financial goals

6. Develop plans for the long-range viability of the organization by engaging in strategic planning, ongoing review of the organization’s mission and bylaws;

a. Do the bylaws address each of the following?

i. Health center mission

ii. Authorities, functions, and responsibilities of governing board as a whole

iii. Board membership (size and composition) and individual member responsibilities

iv. Process for selection/removal of board members

v. Election of officers

vi. Recording, distribution and storage of minutes

vii. Meeting schedule and quorum

viii. Officer responsibilities, terms of office, selection/removal processes

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ix. Description of standing committees (which may include, but are not limited to: executive, finance, quality improvement, personnel, and planning committees) and the process for the creation of ad-hoc committees

x. Provisions regarding conflict of interest; and

xi. Provisions regarding board dissolution

7. Evaluate patient satisfaction, and monitoring organizational assets and performance; and

8. Establish general policies for the center.

b. Board Compositioni. Standard

A. An FQHC’s governing board must be composed of individuals, a majority of whom are being served by the center and, this majority as a group, represent the individuals being served by the center in terms of demographic factors such as race, ethnicity, and sex.

ii. QuestionsA. Does the board composed of at least 9 but no more than 25 members and do the

bylaws list a specific number or merely provide for a range?B. Are a majority of members of the board (at least 51 percent), individuals who

are served by Program?C. Are the patient board members currently registered as patients?D. Have they accessed the center in the past 24 months to receive at least one or

more in-scope service(s) E. Are board member visits as documented, face-to-face contacts between a

patient and a provider who exercises independent professional judgment in the provision of services?

F. As a group, do the patient board members reasonably represent the individuals who are served by the health center in terms of race, ethnicity, and sex?

G. Are the remaining non-patient members representative of the service area community?

H. Do the remaining non-patient members have a broad range of skills, expertise and perspectives, including expertise in community affairs, local government, finance and banking, legal affairs, trade unions, and other commercial and industrial concerns, or social service agencies within the community., etc.

I. Do no more than one half (50%) of the non-consumer board members derive more than 10% of their annual income from the health care industry.

c. Conflict of Interesti. Standard

A. The standards are uncomplicated and are explained in the questions belowii. Questions

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A. Do your bylaws or written corporate board-approved policies include provisions that prohibit conflict of interest by board members, employees, consultants, and those who furnish goods or services to the health center, including:1. Written standards of conduct governing the performance of your

employees engaged in the award and administration of contracts?2. Prohibitions on employees, board members, or agents from participating

in the selection, award, or administration of a contract supported by Federal funds if a conflict of interest would be involved? Such a conflict would arise when an employee, board member (or family member) or an organization that employs, or is about to employ, any such parties, has a financial or other interest in the firm selected for an award.

3. Prohibitions on board members, employees, and agents from soliciting or accepting anything of value from parties to subagreements? (Note: you may set standards for situations in which the financial interest is not substantial or the gift is an unsolicited item of nominal value)

4. Provisions, for disciplinary actions for violations of such standards by in the standards of conduct?

B. Is any board member an employee of Program or an immediate family member of an employee?

C. Does the CEO serve only as a non-voting ex-officio member of the board?

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