DISCLAIMER...Affordable –the Sliding Fee Discount Program • Program Requirements 10 & 11: No One Stands Alone –Working with and within the Community • Program Requirements

3/25/2016

1

Warren J. Brodine

Marcie H. Zakheim, Esq.

De-Mystifying the Nineteen Health Center

Program RequirementsMarch 29 & 30, 2016

Tennessee Primary Care Association

2

DISCLAIMER

This training has been prepared by the attorneys of Feldesman Tucker Leifer Fidell LLP and consultants at W. J. Brodine & Co. The opinions expressed in these materials are solely their views and not necessarily the views of any other organization, including the Tennessee Primary Care Association or the National Association of Community Health Centers.

The materials are being issued with the understanding that the authors are not engaged in rendering legal or other professional services. If legal advice or other expert assistance is required, the services of a competent professional should be sought.

© 2016 Feldesman Tucker Leifer Fidell LLP. All rights reserved. |

www.ftlf.com

3/25/2016

2

3

PRESENTER: MARCIE ZAKHEIM

• Partner at Feldesman Tucker Leifer Fidell, specializing in, among other things, federal grants and grant-related requirements (in particular the requirements of and related to Section 330 of the Public Health Service Act) and nonprofit corporation law;

• Counsel to National Association of Community Health Centers, and numerous Primary Care Associations and health centers nationwide for 19 years; and

• Provides advice and technical assistance services on compliance with federal rules and requirements related to the operation, administration and governance of health centers and health center consortia; assists with development of federal grant applications; and analyzes and provides comments/advice on legislation, regulations and policies impacting health centers and the health care industry in general


www.ftlf.com

4

PRESENTER: WARREN BRODINE

• President of W. J. Brodine & Co., working with health centers, PCAs, national associations, family planning centers/networks, other health care associations, and accountable care entities on program design and implementation, operations, finance and compliance

• 20 years in Community Health Center industry, including COO, CEO, and chief of strategy for three FQHCs, deputy director of a PCA, and work with a national consulting practice


www.ftlf.com

3/25/2016

3


www.ftlf.com

5

ROAD MAP FOR DAY 1

• Welcome & Introductions

• Workshop Overview

• Introduction to the Nineteen Health Center Program Requirements

• Program Requirement 1: It All Starts with Need

• Program Requirements 2, 4, 5, 6: Services & Service Delivery Model

• Program Requirement 3: Ensuring Appropriate Clinical Staffing

• Program Requirement 9: Smooth Operations –Management and Administrative / Financial Staff


www.ftlf.com

6

ROAD MAP FOR DAY 1

• Program Requirement 8: Quality is Key

• Program Requirement 7: Making Care Affordable – the Sliding Fee Discount Program

• Program Requirements 10 & 11: No One Stands Alone – Working with and within the Community

• Program Requirements 17, 18, 19: the “Community” in “Community Health Center” –the Board of Directors

• Wrap-up of Day 1 and Q & A

3/25/2016

4


www.ftlf.com

7

ROAD MAP FOR DAY 2

• Day 1 Debrief

• Program Requirements 12, 13 14: Ensuring Fiscal Viability

• Program Requirement 15: It’s All About the Data

• Program Requirement 16: Bringing This All Together Under Scope of Project

• Assessing Compliance with the Nineteen Requirements – Tips for the HRSA Operational Site Visit

8

Introduction to the Nineteen Health

Center Requirements


www.ftlf.com

3/25/2016

5

CURRENT NATIONAL ENVIRONMENT

• Administration’s commitment to transparency and accountability in health care has led to an unprecedented emphasis on compliance

• Recent events have focused a greater level of attention on the health center program …

• … resulting in A LOT of audits of the health center program

• HRSA Division of Financial Integrity (use of HRSA funds in accordance with legal requirements)

• HRSA Office of Pharmacy Affairs (OPA) 340B audits

• HRSA Federal Tort Claims Act reviews

• Office of Inspector General (OIG) reports (health centers’ compliance with program requirements and grants management requirements)

9© 2016 Feldesman Tucker Leifer Fidell LLP. All rights reserved. |

www.ftlf.com

CURRENT NATIONAL ENVIRONMENT

• HRSA/BPHC has significantly increased its scrutiny of health centers’ compliance with program requirements

• New Policy Information Notices/guidance• PIN 2013-01: Health Center Budgeting and Accounting

Requirements

• PIN 2014-01: Health Center Program Governance Requirements

• PIN 2014-02: Sliding Fee Discount and Related Billing and Collections Program Requirements

• Scope of project guidance (service, mode of delivery and site descriptor guides … and more)

• Coming soon? Draft Program Requirements / Compliance Manual


www.ftlf.com

3/25/2016

6

INTRO TO 19 PROGRAM REQUIREMENTS

• Legal standards mandated by health center statute (Section 330 of the Public Health Service Act (42 USC 254b)) and regulations (42 CFR Part 51c and Part 56 for Migrant Health Centers)

• Grouped into four sections that generally reflect the core components of the health center program: need, services, management & finance, governance

• Program Requirement #1: Need – every health center must be located in or serve a medically underserved area (MUA) or medically underserved population (MUP


www.ftlf.com


• Program Requirements #2-8: Services: every health center must provide, or arrange for the provision of, all required services, which include comprehensive primary and preventive health care services, as well as essential ancillary and enabling services, regardless of ability to pay, payor source and/or insurance status

• Required and Additional Services• Staffing (includes credentialing/privileging)• Accessible hours of operation and locations• After hours coverage• Hospital admitting privileges and continuum of

care• Sliding fee discounts• Quality improvement / assurance plan


www.ftlf.com

3/25/2016

7


• Program Requirements #9-16: Management and finance: every health center must establish administrative, operational, financial and information systems that ensure autonomous / independent operation and fiscal viability

• Key management staff

• Contractual / affiliation agreements

• Collaborative relationships

• Financial management and control policies

• Billing and collections

• Budget

• Program data reporting systems

• Scope of project


www.ftlf.com


• Program Requirements #17-19: Governance: every health center must be governed by a community-based board that meets certain composition requirements and autonomously exercises certain authorities

• Board authority

• Board composition

• Conflict of Interest


www.ftlf.com

3/25/2016

8

15

Program Requirement 1

It All Starts with Need


www.ftlf.com

NEEDS ASSESSMENT

What Are the Key Documents?

• Most recent needs assessment(s)

• Service area map

• UDS patient origin data

• Health center’s list of sites with service area zip codes (Form 5B)


www.ftlf.com

3/25/2016

9

NEEDS ASSESSMENT

What Are the Requirements?

• Must demonstrate and document the needs of the health center’s target population

• Must review and update the service area, when appropriate


www.ftlf.com

NEEDS ASSESSMENT

What Are the Requirements? (cont.)• 42 CFR 51c.303(k): must review service area

annually to ensure that the following criteria are met

• Size is such that services are available and accessible to residents of service area promptly and as appropriate

• Boundaries conform, to the extent practicable, to relevant political subdivisions, school districts, and areas served by federal and state health and social service programs

• Boundaries eliminate, to the extent possible, barriers resulting from physical characteristics, residential patterns, economic and social groupings, and available transportation

• If criteria are not met, health center should revise its service area appropriately


www.ftlf.com

3/25/2016

10

NEEDS ASSESSMENT

What Are Some Compliance Tips?• Written needs assessment

• Comprehensive community needs assessment – more that just the needs section of the annual grant application

• Frequency? Comprehensive assessment at least once per project period (similar to strategic plan)

• Ensure that comprehensive needs assessment is reviewed annually to determine whether updates are necessary

• Utilize both qualitative “person-focused” approaches (interviews with stakeholders, focus groups, community forums) and quantitative data analysis


www.ftlf.com

NEEDS ASSESSMENT

What Are Some Compliance Tips? (cont.)• Ensure that defined service area is consistent

with patient origin data in UDS reports

• Do you include all zip codes served? NO –service area = zip codes/census tracts from where the majority of health center’s patients come

• If service area overlap exists, be prepared to address the overlap, including justification based on unmet need and support from other health centers in service area (see PIN 2009-07 for factors to consider)


www.ftlf.com

3/25/2016

11

21

Program Requirements 2, 4, 5, 6

Services & Service Delivery Model


www.ftlf.com

REQUIRED & ADDITIONAL SERVICES


• Most recent Forms 5A: Services Provided

• Clinical practice protocols and/or related policies and/or procedures that support the delivery of health center services

• Contracts, MOAs, MOUs, etc., for services provided via formal written agreements and/or formal written referral arrangements, including general tracking and referral policies and/or procedures


www.ftlf.com

3/25/2016

12


What Are the Requirements?• Must provide all required clinical and non-clinical

services, either directly, by established written contract, or by formal written referral arrangement (no informal referral arrangements)

• Basic primary and preventive care services

• Referrals to other medical providers and health related-services and agencies

• Patient case management services and eligibility assistance

• Enabling services (outreach, transportation, translation)

• Education regarding availability and use of health services


www.ftlf.com


What Are the Requirements? (cont.)

• If receiving funds to provide services to a targeted special population (migrant, homeless, residents of public housing), must provide full service package PLUS additional services as required by statute PLUS enhanced outreach, case management, eligibility assistance, enabling services


www.ftlf.com

3/25/2016

13


What Are the Requirements? (cont.)• All required services (including non-clinical

services) must be included in the scope of project

• Readily available and reasonably accessible to all patients equally and to all lifecycles of the target population(s)

• Available regardless of an individual’s or a family’s ability to pay, including discounted and nominal fees (applies to in-scope referral arrangements –Form 5A, column III)

• Furnished in a culturally and linguistically appropriate manner


www.ftlf.com



• Services listed on Form 5A under column I -service must be available across all sites of the health center (but not all sites must provide all services as long as all patients have access)

• Services listed on Form 5A under columns II and III (required AND additional) must be documented in a written contract or MOU that at a minimum includes all provisions listed in the Site Visit Guide … more on this under PR #10


www.ftlf.com

3/25/2016

14



• If serving patients with Limited English

Proficiency (LEP) or with disabilities, must take

reasonable steps to provide meaningful access

• Interpretation services

• Auxiliary aids and services (such as sign

language, TTY lines)

• Translation of written materials vital to patient’s

ability to access services

• Communicating the availability of these services to

the patient


www.ftlf.com


What Are Some Compliance Tips?

• Ensure that the mix and level of services reflects the needs assessment / strategic plan

• While not required, should have a plan to ensure access to oral health care, behavioral health care, and pharmacy services

• Confirm that the board-approved budget supports the approved scope, locations, and schedule of services

• Determine most effective mode of delivery for each in-scope service


www.ftlf.com

3/25/2016

15


What Are Some Compliance Tips? (cont.)

• May provide additional/specialty health services based on needs and priorities of the community and the target population, and the availability of other resources – but not required

• Additional/specialty services can be provided in scope or out of scope

• If in-scope, all rules on previous slides apply

• If out-of-scope, cannot support with 330 funds or program income pledged to 330 project and 330-related benefits are not available


www.ftlf.com



• Column III referrals• If providing in-scope service under column I / II

(directly and/or by contract) and by referral (column III), referral agreement may not need to include discounts if eligible patients can access through other means

• For “in-scope” additional/specialty services provided only by referral, if referral provider will not agree to meet requirements (including discounts for individuals who qualify for sliding fee), do not include on Form 5A and offer as an “informal referral”


www.ftlf.com

3/25/2016

16

ACCESSIBLE HOURS & LOCATIONS


• Hours of operation for health center sites

• Most recent Form 5B: Service Sites (Note that the form lists only the TOTAL number of hours per week each site is open, not the specific schedule)

• Most recent Form 5C: Other Activities/Locations

• Service area map with site locations noted


www.ftlf.com



• Must provide services at times and locations that assure access and meet population needs

• Ensure “real” access for the patient population• Hours – nights and weekends

• Locations – generally located in the areas where the target population lives/works, and can be reasonably accessed via public transportation (as necessary)


www.ftlf.com

3/25/2016

17



• Take into consideration input/feedback from patients

• If serving special populations, may need to go to where the patients are (e.g., homeless shelters, migrant camps, mobile vans)


www.ftlf.com

AFTER-HOURS COVERAGE


• Health center’s after hours coverage policies and/or procedures

• Agreements, systems and/or contracts that support after hours coverage, if applicable

• Most recent Form 5A: Services Provided ("Coverage for Emergencies During and After Hours“)


www.ftlf.com

3/25/2016

18


What Are the Requirements?• Must have clearly defined arrangements for

patients to access professional coverage for medical emergencies after regularly scheduled hours

• What does that mean? • Telephone access to a covering clinician (not

necessarily a health center clinician) …

• Who can exercise independent professional judgment in assessing a patient's need for emergency medical care and …

• Refer patients to appropriate locations for such care, including emergency rooms, as necessary


www.ftlf.com



• Specific arrangements for after-hours coverage may vary by community

• Ensure patients are aware of after-hours coverage and that patient information is available in culturally and linguistically appropriate manner – appropriate literacy levels and languages are a must!

• Ensure that after-hours telephone line has appropriate linguistic capabilities

• Call your center!


www.ftlf.com

3/25/2016

19

HOSPITALIZATION


• Hospital admitting privileges agreements/documentation

• Most recent Form 5C: Other Activities/Locations (if applicable, hospitals where health center providers have admitting privileges should be noted on the form)


www.ftlf.com

HOSPITALIZATION

What Are the Requirements?• Must have admitting privileges at one or more

referral hospitals

• In cases where hospital admitting privileges and membership are not possible, must have firmly established arrangements for patient hospitalization, discharge planning, and tracking, or other such arrangement to ensure appropriate communication and continuity of care

• Must admit and round (or arrange admission/rounding) for all patients and all lifecycles, including adults, pediatrics, obstetrics


www.ftlf.com

3/25/2016

20

HOSPITALIZATION


• Must have internal policies, systems, or procedures to assure continuity of care for hospitalized health center patients

• Hospitalization / emergency department referral procedure

• Discharge follow-up

• Patient tracking (e.g., tracking laboratory and radiology results not available at the time of discharge)


www.ftlf.com

HOSPITALIZATION

What Are Some Compliance Tips?• Don’t need arrangements with every hospital in

service area, as long as all patients can access inpatient care

• Use best efforts to get hospital to provide information on center patients admitted through emergency room (for follow-up care purposes)

• Ensure patients are aware of hospitalization coverage and that patient information is available in culturally and linguistically appropriate manner – appropriate literacy levels and languages are a must!


www.ftlf.com

3/25/2016

21

HOSPITALIZATION


• Do “rounding” services have to be available on discounted basis for patients who would otherwise qualify for discounts if health center rounded directly?

• Unclear – some say yes, some say no

• Best practice – distinguish between “rounding” versus inpatient procedures and services and

ensure “rounding” is available on discounted basis


www.ftlf.com

42


Ensuring Appropriate Clinical Staffing


www.ftlf.com

3/25/2016

22

STAFFING


• Staffing profile from grant application

• Provider contracts, agreements and sub-recipient arrangements related to staffing

• Credentialing and privileging policies and procedures along with actual credential/privilege files, documentation of provider licensure or certification for all licensed or certified health center practitioners, and privileging lists


www.ftlf.com


www.ftlf.com

44

STAFFING

What Are the Requirements?• Health center 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

• Affiliation policies allow contracting for core staff of primary care providers for good cause – must have contract that meets requirements of PR #10

• Staff must be appropriately licensed, credentialed and privileged

3/25/2016

23

STAFFING


• Health center must provide for a system of credentialing and privileging providers and other licensed or certified health care practitioners

• Ultimate authority for credentialing and privileging is vested in the governing board, may delegate (via resolution or bylaws) to an appropriate individual

• But still must approve policies and/or procedure


www.ftlf.com

STAFFING


• Seek to determine if the core staff (clinical and

non-clinical) is appropriate to serve the patient

population and adequate for carrying out the

approved scope of project (e.g., staffing for

services included on Form 5A Column I and for

sites on Form 5B) (MORE ON SCOPE LATER)

• NOTE: There is no required national health

center staffing number/ratio or threshold


www.ftlf.com

3/25/2016

24

STAFFING


• Establish plans for vacancies/succession

among providers

• Helps to mitigate against vacancies

• Upon site visit can demonstrate that the

organization is prepared to handle planned and

acute vacancy and absence


www.ftlf.com

STAFFING


• Credentialing and privileging is the heart of this

requirement

• Review PIN 2001-16 and PIN 2002-22 (which

updates 2001-16)

• Site Visit Guide (2014) pages 8-9 for frequency

and documentation requirements (see handout)


www.ftlf.com

3/25/2016

25

STAFFING


• Educate board and staff on the differences between

credentialing and privileging

• If credentialing and/or privileging is delegated,

create a regular discussion item with a frequency

(like quarterly) to make sure that the information is

still getting before the governing board

• If health center is FTCA deemed, compare and

contrast FTCA credentialing requirements with

Program Requirements (there is usually a PAL for

this)


www.ftlf.com

STAFFING


• Privileging and credentialing has to be done for

all licensed/certified practitioners providing

services at health center sites, including

• Employees

• Locum tenens

• Contracted providers

• Volunteers

• Credentialing with health insurance plans or

hospitals does not substitute for PR#3


www.ftlf.com

3/25/2016

26

STAFFING

What Are Some Compliance Tips? (cont.)• Use PIN 2002-22 to review:

• Provider types for credentialing

• Definitions of primary and secondary source verification

• Privileging

• Use Site Visit guide pages 8 & 9 as a template for compliance

• Ensure credentialing files are complete and up to date

• Ensure re-credentialing and re-privileging is current


www.ftlf.com

STAFFING

What Are Some Compliance Tips? (cont.)• For secondary source verification, if the health

center is relying on copies made of original documents (and the copies are made internally) the staff persons must be ”approved” (presumably designation by policy or procedure would suffice)

• Review the appeal process for a licensed independent practitioner if privileges are revoked or denied

• Make sure that either the board or the delegated individual properly documents the expiry or revocation of privileges for a provider/certified staff member who terminates employment or other provider status in a timely fashion


www.ftlf.com

3/25/2016

27

STAFFING


• If a health center uses temporary privileges,

according to PIN health centers may do so if

they follow guidelines of The Joint Commission

(and the process for temporary privileges

should be outlined in policy and/or procedure)

(http://www.jointcommission.org/assets/1/18/jcp

0713_revisions_req_ahc.pdf)

• N.B.: this is the most recent we could locate easily,

but may have been superseded


www.ftlf.com

54


Smooth Operations – Management and

Administrative / Financial Staff


www.ftlf.com

http://www.jointcommission.org/assets/1/18/jcp0713_revisions_req_ahc.pdf)

3/25/2016

28

KEY MANAGEMENT STAFF


• Health center organizational chart

• Key management staff position descriptions and

biographical sketches

• Key management vacancy announcements (if

applicable)

• Most recent Form 5A: Services Provided and

Form 5B: Service Sites

• UDS Summary Report


www.ftlf.com


What Are the Requirements?• Must have a CEO or Executive Director/Project

Director

• Affiliation policies require direct employment by health center (with exceptions for public entities only)

• Must have a key management team of a size and composition appropriate for the size and needs of the health center

• Affiliation policies allow contracting for key management for good cause – must have contract that meets requirements of PR #10


www.ftlf.com

3/25/2016

29



• Must be either fully staffed as it lays out its

organizational chart or be actively recruiting for

the vacancy or implementing interim measures

to address the key management capacity


www.ftlf.com


What Are Some Compliance Tips?• If the project director is not the CEO/ED, be

prepared to explain how it works, and how information gets to the board of directors*

• Highly recommended that the CEO/ED be the project director for purposes of HRSA

• Understand the rationale behind the organizational chart of the health center

• Size and complexity of the organization usually play a role

*We will assume that the CEO/ED is the PD for the remainder of this section, since it’s the most common arrangement.


www.ftlf.com

3/25/2016

30


What Are Some Compliance Tips? (cont.)• Have a succession plan in place for CEO/ED

• Elements of a succession plan that relate to the requirement:• Process for informing HRSA of vacancy, whether

acute or planned

• Plan for interim project directorship to manage HRSA relationship

• Recruitment plan that can be activated

• Consider a similar succession plan for the CMO and CFO

• Other senior positions should have a succession plan as well, but less critical from a HRSA perspective


www.ftlf.com


What Are Some Compliance Tips? (cont.)• If the health center has to activate a temporary

interim plan:• What are the criteria for designating an interim in a key

management position?

• Would the interim be from an internal source, or external source?

• Remember to advise project officer of any interim role in the key management staff

• Compare current staffing against staffing profile (a key benchmark in compliance review)

• If a substantive change occurs in organizational chart, advise project officer (CEO/ED/Project Director will require prior approval in EHB)


www.ftlf.com

3/25/2016

31

61


Quality is Key


www.ftlf.com

QUALITY ASSURANCE / IMPROVEMENT

What Are the Key Documents?• Quality improvement/quality assurance (QI/QA)

plan and related and/or supporting policies and/or procedures (e.g., incident reporting system, risk management policies, patient safety policies)

• Clinical Director’s job description

• HIPAA-compliant patient confidentiality and medical records policies and/or procedures

• Clinical care policies and/or procedures

• Clinical information tracking policies and/or procedures


www.ftlf.com

3/25/2016

32


What Are the Requirements?• Must have an ongoing Quality

Improvement/Quality Assurance (QI/QA) program that includes clinical services and management and maintains the confidentiality of patient records

• Management = clinical management (not administrative/financial management)

• Must include clinical director whose focus of responsibility is to support the quality improvement/assurance program and the provision of high quality patient care


www.ftlf.com


What Are the Requirements? (cont.)• Must include periodic assessment of the

appropriateness of the utilization and quality of services provided or proposed to be provided to individuals served by the health center, which shall

• Be conducted by physicians or by other licensed health professionals under the supervision of physicians

• Be based on the systematic collection and evaluation of patient records

• Identify and document the necessity for change in the provision of services by the health center and result in the institution of such change, where indicated


www.ftlf.com

3/25/2016

33



• Clinical director for QA

• May be full or part time staff

• Should have appropriate training/background (MD,

RN, MPH, etc.), as determined by the needs/size

of the health center

• Does not have to be the Medical Director, as long

he/she has clear responsibility, along with other

staff as appropriate, for conducting QI/QA

assessments/activities

• Ensure job description includes QA!


www.ftlf.com


What Are Some Compliance Tips? (cont.)• Medical records policies and/or procedures

should address • Establishing and maintaining a clinical record

for every patient receiving care at the health center

• Privacy and Confidentiality (in accordance with HIPAA)

• Procedures to enable patients to give consent for release of medical record information

• Security of current and archived medical record information


www.ftlf.com

3/25/2016

34



• Involve the board early - include relevant quality

information in board orientation and ongoing

training (e.g., common quality measures and

benchmarks, reporting requirements, health center

QA program, etc.)

• Have clinical information systems in place for

tracking, analyzing and reporting key performance

data related to the organization’s plan

• Develop and utilize a summary, or “dashboard,” of

key indicators


www.ftlf.com



• Conduct and document QI/QA assessments on

a regular basis, including assessments of

• Appropriateness of service utilization and quality

of services delivered

• Peer review

• Clinical performance measure trends

• Health status/outcomes of health center patients

• The plan should include methods for measuring

and evaluating patient satisfaction


www.ftlf.com

3/25/2016

35



• The findings of the QI/QA process should be used to improve organizational performance –results should be

• Shared or reviewed by key management staff to inform health center operations

• Reported to the governing board on a regular basis (dashboards, periodic briefings from staff) –minutes must show this!

• Review FTCA QA requirements (there is usually a PAL for this) and ensure that QA plan meets such requirements


www.ftlf.com


What Are Some Compliance Tips? (cont.)• Recent reviewer focus on QA/QI committee

minutes – at a minimum, must• Include dates of the meetings, attendees and

absentees, identified by title and name, summaries

• Demonstrate clear data-driven performance goals and regularly discusses objectives, action steps, improvement activities and proactive problem identification (including responsible parties, assigned tasks, open and closed action items)

• Demonstrate utilization of a recognized methodology to monitor, analyze, and evaluate data driven projects


www.ftlf.com

3/25/2016

36

71


Making Care Affordable – the Sliding Fee

Discount Program


www.ftlf.com

SLIDING FEE DISCOUNT PROGRAM

What Are the Key Documents?• Schedule of fees/charges for all services in scope

• Sliding fee discount schedules (SFDS)

• Policies and supporting operating procedures

• Sliding fee signage and/or notification methods

• Documents/forms that support the eligibility process for the sliding fee discount program

• Any other supporting documents such as evaluations of the sliding fee discount program or basis for setting nominal charges

• Most recent Form 5A: Services Provided

72

3/25/2016

37


What Are the Requirements – Application to Centers, Patients and Services?• Applies to all Section 330-funded health centers

(including sub-recipients and special population only grantees) and FQHC look-alike entities

• Applies to all patients served by the health center (can consider unique characteristics of populations served in establishing operating procedures)

• Applies to all in-scope services / service arrangements for which a charge has been established, regardless of service type or mode of delivery i.e., all required and additional services listed on Form 5A in any column (I, II, and III)

73


What Are the Requirements – Informing Patients & Evaluation/Revision?• Must have board-approved methods for

informing patients about the availability of sliding fee discounts that are effective and appropriate for the language and literacy levels of the patient population

• Must have board-approved policies and procedures to

• Revise the SFDS annually for compliance with the then current Federal Poverty Guidelines; AND

• To assess the effectiveness of the SFDS structure (annually) and of the entire SFDP (once every three years) in reducing financial barriers to care

74

3/25/2016

38


What Are the Requirements – Fee Schedule?• Fees must be designed to cover reasonable costs

and must be consistent with locally prevailing rates or charges for the service

• Relative weight may vary depending on the situation of the health center

• General “rule of thumb” – except under exceptional circumstances, cover costs first

• Fee schedule must address all in-scope services (required and additional) and be used as the basis for seeking payment from patients as well as third party payors

75


What Are the Requirements – Fee Schedule? (cont.)• Step #1: Determine which services will have distinct

fees• Can combine services into single fee (such as

visits with related supplies, lab) – consistent with locally prevailing standards of care and charges

• Can use global fee for services that require multiple visits (e.g. prenatal care) – but check payor rules and contracts

• Can have distinct fees for non-service in-scope elements (such as enabling services, outreach) if they are typically reimbursed separately within the marketplace

76

3/25/2016

39


What Are the Requirements – Fee Schedule? (cont.)• Step #2: Determine actual costs of providing in-

scope required and additional services

• Step #3: Consider “locally prevailing rates” for these services

• Look at charges of other community providers for the same or similar services – but be careful not to implicate potential antitrust concerns

• Medicare, Medicaid, private providers, or commercial sources

• Document that you have conducted this review!

77


What Are the Requirements – Eligibility Verification?• Must have a system in place to determine eligibility

for patient discounts adjusted on the basis of ability to pay

• Must assess all patients and all eligible patients must be offered opportunity to apply

• Income and family size are the sole factors in determining eligibility for SFDP – can consider “unique population characteristics” in developing supporting operating policies and procedures

• No net worth or asset tests

78

3/25/2016

40


What Are the Requirements – Eligibility Verification? (cont.)

• Board must define “income” and “family size” and necessary documentation; can use self-attestation as long as it is applied equally to similarly situated patients – must be included in board-approved SFDP policy

• “Income” can be defined using / adapting definitions from other sources, such as Census Bureau, IRS, other federal programs

• “Family size” can include individuals not living with patient but supported by patient’s income

79


What Are the Requirements – Eligibility Verification? (cont.)

• Cannot require patient to apply and be turned down for insurance or related third party coverage before offering opportunity to apply for SFDP

• HOWEVER, if patient refuses to provide documentation, may charge him/her the full fee

• Process – must be efficient, respectful and culturally appropriate

• Reevaluation – at least annually

80

3/25/2016

41


What Are the Requirements – Sliding Fee Discount Schedule (SFDS)?• For patients with incomes between 100% and

200% of Federal Poverty Guidelines (FPG), must charge fees in accordance with a sliding discount policy

• Must have at least three discount pay classes that are tied to “gradations” in income level

• Flexibility to determine number of pay classes and types of discounts (i.e. % of fee or flat / fixed fee) as long as not creating barriers to care

• If using multiple SFDS for distinct types/categories of services or different modes of delivery, each one must meet the structural requirements

81


What Are the Requirements – Sliding Fee Discount Schedule (SFDS)? (cont.)

• No regular discounts for patients with annual incomes above 200% FPG

• If receiving non-330 funds that require discounts above 200%, may reduce patient payments accordingly

82

3/25/2016

42


What Are the Requirements – Nominal Fee? • Must provide a full discount to patients with

annual incomes at or below 100% of the FPG; at most, can charge nominal fee

• Flat fee that does not reflect the true cost of the service and that is considered nominal from patients’ perspective

• Must be less than the fee paid by patient in lowest rung of SFDS

• Not a payment threshold, minimum charge/fee or co-payment

• TIP: document evaluations that nominal fee meets the above definition and is not a barrier to care

83


What Are the Requirements – Referral Agreements? • Services provided through in-scope referral

arrangements (Form 5A, Column III)• Referral provider must offer a discount schedule

that, at a minimum, is consistent with SFDS / nominal fee requirements (does not have to mirror center’s SFDS and can offer deeper discounts)

OR• Health center supports the cost of care by paying

the referral provider the difference between the provider’s charge and what the patients should pay under discount schedule

• More on this under PR #10

84

3/25/2016

43


What Are the Requirements – Supplies and Equipment? • Service-related supplies and equipment

charged separate from the underlying service (e.g., dentures, crowns, prescriptions drugs) can be discounted under a structure different from SFDP

• Applies to supplies and equipment related to but not included in underlying service as part of prevailing standards of care

• Charge should be less than prevailing charge, but can be higher than normal discount (such as recoupment of costs)

• Underlying professional service must be discounted under SFDP

85


What Are the Requirements – Supplies and Equipment? (cont.)

• Service-related supplies and equipment (cont.)• Should include availability of waivers / payment

reductions / payment plans to ensure access

• Must inform patient prior to providing service that the supplies / equipment will be charged separately and what that charge will be (and if payment plans are available, what those are)

86

3/25/2016

44


What Are the Requirements – Patient Co-Payments?• Not required to offer full slide to insured patients;

however, if patient co-payment is more than he/she would have paid based on his/her SFDS pay class, at a minimum, must reduce co-payment to applicable SFDS pay class amount (subject to legal/contractual limitations)

• TIP: review all payor contracts to determine whether they explicitly prohibit reduction of co-payments (versus shift financial responsibility of collection to the health center)

87


What Are the Requirements – Waivers / Reductions of Payments?

• Cannot deny services due to inability to pay for such services – must assure that any fees or payments for such services will be reduced or waived as necessary to ensure access

• More on this under PR #13

88

3/25/2016

45


What Are the Requirements – Board Role?• Full board approval of all required policies to

ensure that the SFDP remains patient centered, improves access to care and assures that no patient is denied services due to inability to pay

• Eligibility criteria, including definitions of family/income and frequency of re-evaluation

• Documentation and income verification requirements

• Structure of the Sliding Fee Discount Schedule (SFDS)

• Billing and collection policies• Policies to waive/reduce fees, etc.

89


What Are the Requirements – Board Role? (cont.)• If health center chooses to implement the

following, board also must approve:• Alternative eligibility verification

• Nominal charges (versus full discount)

• Discounts for supplies/equipment

• Alternative billing and collection policies (including payment incentives)

• Board should not approve supporting operating procedures that implement these policies BUT should get feedback as part of the board’s evaluation responsibility

90

3/25/2016

46



• Non-compliance with the SFDP is one of the

most common findings during the OSV, resulting

in grant conditions for numerous grantees –

why?

• Includes several elements, all of which must be

met

• Based on newest policy issued by HRSA – some

folks are still “figuring it out”

• Inconsistent interpretation and application among

reviewers


www.ftlf.com



• Carefully review PIN 2014-02 and all of the

questions posed in the Site Visit Guide under

both PR 7 and PR 13 and ensure that your

SFDP policy and procedure includes ALL

ELEMENTS addressed in both documents

• If some elements are included in other

policies/procedures (such as billing and

collection), include references / links


www.ftlf.com

3/25/2016

47


www.ftlf.com

93



• Secure board approval for entire SFDP

(especially important for “grey areas”)

• Ensure that all patients are asked about income

and family size (need this information for UDS)

• If patient formally ”opt outs” of assessment,

document refusal to be screened for discount


What Are Some Compliance Tips? (cont.)• Train and prepare all management, staff and board

members about the new policy / procedure and its various elements

• Coordinate implementation among different functional areas involved

• Ensure that everyone is on the same page regarding how the SFDP and its various elements are applied in practice (and make sure that what is on paper reflects what is being done)

• Especially if the health center has multiple sites – it’s easy for local workarounds to develop


www.ftlf.com

3/25/2016

48



• Update all materials and signage so that it

reflects the new SFDP policy and procedure –

must be clear and accurate regarding eligibility

requirements and availability of discounts AND

must be sufficiently visible to and understood by

patients


www.ftlf.com

96

Program Requirements 10 & 11

No One Stands Alone – Working with and within

the Community


www.ftlf.com

3/25/2016

49

CONTRACTUAL AND AFFILIATION AGREEMENTS

What Are the Key Documents? • Contract(s) or sub-award(s) (subrecipient agreements)

for a substantial portion of the health center project

• Agreements for a substantial portion of the health center project

• Contract with another organization for core primary care providers

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

• Any other key affiliation agreements, if applicable

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


www.ftlf.com


What Are the Requirements?• Must maintain independence and compliance

with all core requirements – arrangement• Cannot threaten or limit the health center’s

autonomy and/or integrity• Cannot compromise the health center’s

compliance with federal requirements, including procurement

• Must comply with HRSA affiliation policies

• Sub-recipient agreements must have: (i) assurances in place that the sub-recipient complies with all statutory and regulatory requirements; and (ii) provisions for monitoring by health center (including on-site reviews)


www.ftlf.com

3/25/2016

50


What Are the Requirements? (cont.)• Must exercise appropriate oversight and

monitoring, including

• Contract administration / management system that ensures contractor compliance

• Appropriate oversight of contractor performance and of the contracted services provided to the health center’s patients

• Must have board-approved policies that ensure appropriate procurements (don’t forget about those OIG audits!)


www.ftlf.com


What Are the Requirements –Procurement? • In general, must provide open and full competition

and eliminate unfair competitive advantage

• 45 C.F.R.§ 75.328(c): Solicitations must include

• Clear and accurate technical description but no unduly restrictive features

• Where practical, describe technical functions

• All requirements for bidders and offerors (clearly identified)

• Criteria for evaluation of bids and proposals –make it clear what they will be evaluated on


www.ftlf.com

3/25/2016

51


What Are the Requirements –Procurement? (cont.)• Award contracts only to “responsible”

contractors possessing the ability to perform successfully under the terms and conditions of a proposed procurement

• 45 C.F.R. §75.329: sole source can be used only if one of the following situations occur

• Item is available from only one source• Public exigency or emergency• Authorized by HHS awarding agency• After solicitation from a number of sources,

competition deemed inadequate


www.ftlf.com


What Are the Requirements –Procurement? (cont.)• Do not do business with businesses or

individuals who have been debarred or suspended

• 45 C.F.R. § 75.335 and Appendix II to Part 75– Provides contract requirements for “all” federally

funded contracts, including remedial actions in event of contractor breach, access to records, contractor compliance with certain federal laws

– Some apply to contracts over $10,000; Others over $100,000; Others over Simplified Acquisition Threshold (SAT) currently at $150,000


www.ftlf.com

3/25/2016

52


What Are the Requirements – Contract Administration?

• 45 C.F.R. § 75.327(b): must maintain a

contract administration system that ensures:

• Contractor’s compliance with terms, conditions

and specifications of the contract

• Health center’s monitoring and oversight of the

contractor’s performance

• Adequate and timely follow-up

• Appropriate contract dispute provisions


www.ftlf.com


What Are the Requirements – Contract Administration? (cont.)

• Additional items to include in procurement files

• Solicitation and any amendments

• Contract and any amendments

• Invoices

• Correspondence

• Monitoring reports

• Memos to file as necessary


www.ftlf.com

3/25/2016

53


What Are the Requirements – Other HRSA Requirements? (see handout)• Program Requirement #2 requires that the

written agreement describe how:• Service will be documented in patient record

• Health center will bill for service and provide payment to contractor

• Health center’s policies and procedures will apply to the contracted service

• Program Requirement #7 requires that the written agreement describe how contracted services will be discounted in accordance with a SFDS that meets the SFDS criteria


www.ftlf.com


What Are the Requirements – Formal Written In-Scope Referral Agreements? (see handout)

• Program Requirement #2 requires that the written agreement ensures that service will be available equally to all patients, regardless of ability to pay

• How the referral will be made and managed

• How the health center will track patients

• The process for referring patients back to the health center for appropriate follow-up care


www.ftlf.com

3/25/2016

54


What Are the Requirements – Formal Written In-Scope Referral Agreements? (cont.)• Program Requirement #7 requires that the

referred service be discounted in a manner that, at a minimum, meets requirements of PIN 2014-02 or the health center must pay the difference

• Meet the “structural requirements” in the PIN

• Be applied uniformly to similarly situated patients

• Take into consideration patient access

• Referral provider can offer deeper discount


www.ftlf.com

COLLABORATIVE RELATIONSHIPS


• Letters of Support

• Memoranda of Agreement/Understanding

• Other relevant documentation of collaborative relationships


www.ftlf.com

3/25/2016

55

COLLABORATIVE RELATIONSHIPS


• Must make efforts to establish and maintain collaborative relationships with other health care providers, including other health centers, in the service area of the center

• Must secure letter(s) of support from existing

health centers in the service area or provide an

explanation for why such letter(s) of support

cannot be obtained (remember service area

overlap)


www.ftlf.com

CONTRACTS, AFFILIATIONS & COLLABORATIONS


• Consider all collaborative partners serving the same underserved community(ies) / population(s)

• Document in writing all linkages, partnerships and collaborative arrangements/activities, regardless of whether they are included on Form 5A

• Coordinate with non-health care agencies, networks and programs serving / supporting the same special population


www.ftlf.com

3/25/2016

56

CONTRACTS, AFFILIATIONS & COLLABORATIONS

What Are Some Compliance Tips? (cont.)• Check State law for any limitations on

acceptable FQHC arrangements (such as limitations on co-location arrangements or including contracted sites in-scope)

• Ensure that contracts and referral agreements include ALL requirements from the health center site visit guide and procurement rules – no “points” for partial compliance or best efforts

• If the referral agreements do not offer patient access to a SFDS that is at least as generous as center’s SFDS, the health center can “subsidize”


www.ftlf.com

112

Program Requirements 17, 18, 19

The “Community” in “Community Health Center” –

the Board of Directors


www.ftlf.com

3/25/2016

57

BOARD AUTHORITY

What are the Key Documents?

• Organizational/corporate bylaws

• Minutes of recent board meetings

• Health center policies and/or procedures

• Board annual meeting schedule

• List of board committees

• If Applicable: Co-Applicant Agreement for public

centers


www.ftlf.com

BOARD AUTHORITY

What Are the Requirements? Board must exercise proscribed authorities in statute, regulations, Site Visit Guide, PIN #2014-01: Health Center Program Governance and/or other HRSA guidance and policies

• Hold 12 regular monthly meetings and keep appropriate minutes demonstrating exercise of authorities

• Select, annually evaluate and as necessary, dismiss of the CEO

• Approve applications related to the health center project, including annual grant applications, Change in Scope applications, and other requests to HRSA

• Approve annual health center operating and capital budgets and accept / approve annual audit


www.ftlf.com

3/25/2016

58

BOARD AUTHORITY


• Establish health care policies, including

• Scope, availability and mode of delivery of

services

• Locations and hours of service provision

• Quality of care audit policies and quality

assurance/improvement plan

• Establish general operating policies (personnel,

financial management, conflict of interest)


www.ftlf.com

BOARD AUTHORITY

What Are the Requirements? (cont.)• Engage in long-term strategic (3 years)

planning, including update of mission, goals and plans as necessary and appropriate

• Measure and evaluate progress in meeting annual and long-term financial and programmatic goals

• Evaluate health center activities: service utilization patterns; productivity; patient satisfaction; achievement of project objectives; patient grievances

• See handout


www.ftlf.com

3/25/2016

59

BOARD AUTHORITY

What Are Some Compliance Tips?• Make sure that you can prove that the board

properly exercises all proscribed authorities –remember, there is no partial compliance!

• Documentation should include board and committee meeting agendas and minutes, board packet attachments (including management reports and presentations), work plans, strategic planning meeting notes, etc.

• For big issues, craft resolutions that include why an action is being taken rather than just taking votes to be recorded in the minutes (makes it easier to follow the board’s decision-making)


www.ftlf.com

BOARD AUTHORITY

What Are Some Compliance Tips? (cont.)• Know the board “calendar” – what the board has

done this past year and when those activities where performed

• Be prepared to discuss specific examples of key responsibilities exercised during the year

• What type of information did the board review?

• What was the discussion during the board meeting?

• How was all of this used by the board to make decisions?

• Ensure that Bylaws are up to date and include all provisions specified in Site Visit Guide


www.ftlf.com

3/25/2016

60

BOARD COMPOSITION


• Composition of board of directors/most recent Form 6A: Board Composition

• Organizational/corporate bylaws

• Board member application and disclosure forms

• UDS Summary Report

• If Applicable: Form 6B: Waiver of Governance Requirements 5)


www.ftlf.com

BOARD COMPOSITION

What Are the Requirements?• Size of board must be between 9 – 25 members

• Patient board members must comprise majority of the board and collectively, must reasonablyrepresent patients in terms of demographic factors such as race, ethnicity and gender

• Must be current registered patient who, within the past 2 years, has accessed one or more in-scope services that generated health center visit(s)

• May be a legal guardian of a patient who is a dependent child or adult, or a legal sponsor of a patient who is an immigrant


www.ftlf.com

3/25/2016

61

BOARD COMPOSITION


• Non-patient board members must represent the community served by the health center andreflect a broad range of skills and expertise (consistent with regulatory requirements)

• No more than ½ of non-patient board members can earn more than 10% of income from health care industry

• Special population representation, as applicable


www.ftlf.com

BOARD COMPOSITION

What Are Some Compliance Tips?• Ensure that the board size complies with

regulations and with the health center’s Bylaws, and is appropriate for size and complexity of center and diversity of community

• Ensure that all patient board members meet the definition in governance PIN at the time of the OSV

• Don’t ignore the non-patient board member requirements – you must comply with those too!

• If non-patient board members do not live or work in the service area, document their connection to the community

• Define “health care industry”


www.ftlf.com

3/25/2016

62

CONFLICT OF INTEREST POLICY


• Corporate Bylaws

• Most recent update of Conflict of Interest policy

and related procedures

• Procurement policies and/or procedures


www.ftlf.com


What Are the Requirements? Bylaws, Conflict of

Interest (COI) Policy and/or Standards of Conduct

(SOC) must

• Prohibit / manage conflicts by board members,

employees, consultants and those who furnish

goods / services to the health center, including

• Disclosure of interests

• Recusal from voting

• Consequences of violating the standards

• Other provisions from procurement rules


www.ftlf.com

3/25/2016

63



• State explicitly that no board member will be an

employee of the health center or an immediate

family member (spouse, child, parent, sibling – by

blood, marriage or adoption) of an employee

• State explicitly that the CEO may serve only as a

non-voting ex-officio member of the board


www.ftlf.com


What Are Some Compliance Tips?• Ensure that the Bylaws, COI Policy and/or SOC are

up to date and include all provisions specified in Site Visit Guide

• If provisions are included in more than one document, ensure all documents are available to reviewers (make the connection) – for example

• SOC may include the conflict of interest policy

• Bylaws may include prohibitions on family members and CEO (see prior slide, last two bullets)

• Ensure that COI statements for all board members and staff are updated annually and kept on file


www.ftlf.com

3/25/2016

64

127

Program Requirements 12, 13, 14

Ensuring Fiscal Viability


www.ftlf.com

128

FINANCIAL MANAGEMENT AND CONTROL POLICIES

What Are the Key Documents?• Most recent independent financial audit and management

letter, including audit corrective action plans based on prior year audit findings, if applicable (for new grantees, most recent monthly financial statements if a first audit has not been completed)

• Most recent A-133 Compliance Supplement (grantees only)

• Financial management/accounting and internal control policies and/or procedures

• Chart of accounts

• Balance sheet and income statement

• Most recent Health Center Program required financial performance measures/UDS Report

• Most recent Income Analysis (Form 3)


www.ftlf.com

3/25/2016

65

129



• Must have accounting and internal control

systems

• Appropriate to size and complexity of the

organization

• Reflective of Generally Accepted Accounting

Principles (GAAP)

• Separates functions in a manner appropriate to

the organization’s size in order to safeguard

assets and maintain financial stability


www.ftlf.com

130



• Health center must assure that:

• Annual independent audit is performed in

accordance with federal audit requirements

• Corrective action plan addressing all findings,

questioned costs, reportable conditions, and

material weaknesses cited in the Audit Report is

submitted


www.ftlf.com

3/25/2016

66



• Accounting and internal controls appropriate to size and complexity

• Ask the independent auditor to review this (they will – it’s part of standard audit procedure, but ask anyway)

• Make sure they look at the separation of federal and non-federal transactions

• Review chart of accounts for federal vs. non-federal sources and expenditures

• And that tracks to the general ledger


www.ftlf.com



• Independent auditor’s assessment will be very

important

• A rigorous internal control review will be excellent

back-up

• Be sure to note any deviation from the state of

affairs at the time of the audit (position vacancies,

etc., and how internal control is being preserved)


www.ftlf.com

3/25/2016

67



• Reflective of GAAP (including accumulation of

costs)

• Generally-accepted accounting principles –

normal

• Again, auditors will reflect this in their report

• Helpful to use GAAP statements in board

presentations as well, rather than other kinds of

roll-ups (though executive summaries are

sometimes presented in non-GAAP ways)


www.ftlf.com



• Accumulation of costs

• Means health centers use the principles of cost

accounting within the accrual method

• Recording expenses at cost

• Regularly accumulating long-term costs over the

course of the year


www.ftlf.com

3/25/2016

68


What Are Some Compliance Tips? (cont.)• Safeguarding assets

• Ensure that assets are not misappropriated

• Maintain and utilize inventory

• Make good procurements (see PR#10 earlier)

• Maintaining financial stability• Include focus on revenue generation, billing, proper

and compliant rebilling and denials management

• Maintain cash flow appropriately

• Key term is “appropriate to the organization’s size” – no unrealistic expectations (though have your auditor acknowledge)


www.ftlf.com


What Are Some Compliance Tips? (cont.)• Support the distribution of an employee’s wages or

salary among various activities and cost objectives in a case where an employee:

• Works on more than one federal award

• Works on a federal award and a non-federal award (like a state grant or foundation grant)

• An indirect cost activity and a direct cost activity (indirect cost activity like building maintenance, for instance)

• Two or more indirect cost activities where the allocation method is different

• An unallowable activity (like an out-of-scope activity) and a direct or indirect cost activity


www.ftlf.com

3/25/2016

69



• Budget estimates are not sufficient, but may be

used for interim accounting, provided there are

specific reconciliation steps

• Can apply for alternative methods if

organization receives more than one federal

award, and all awarding agencies must agree

and approve before implementation


www.ftlf.com


What Are Some Compliance Tips? (cont.)• Personal activity reports that outline all the funding

sources are the gold standard in tracking time and effort

• Semi-annual certifications can be used for employees who do all of their work on one award or project (most likely example is a medical assistant who only works the floor)

• Health centers need written policies and procedures• Good faith estimates/employee’s independent

judgment

• Timeliness (no waiting and doing a year’s worth of time sheets in the last week of the year)

• Penalties for non-compliance

• Monitoring process


www.ftlf.com

3/25/2016

70



• Annual financial audit – complete audit means:

• Auditor’s report

• Compliance Supplement (grantees only)

• Reports to board/Management letter issued by the

auditor (and documentation that the board

reviewed in minutes of committees and board)


www.ftlf.com


What Are Some Compliance Tips? (cont.)• Single audit (or program-specific audit) threshold at

$750,000

• If exempt, records must be available to the federal agency, a pass-through agency (if any) and to the federal General Accounting Office (GAO)

• 45 CFR 75.503 (e) : HRSA (as an awarding agency) can request a single or program-specific audit for a non-federal entity that would otherwise not require one (e.g., below $750K in federal expenditures)

• Must request 180 days out

• Must pay incremental cost of additional audit work


www.ftlf.com

3/25/2016

71


What Are Some Compliance Tips? (cont.)• If the annual audit has corrective action plans must

address all previous

• Audit findings

• Questioned costs

• Reportable conditions

• Material weaknesses

• Make sure if these are present and cleared, that the subsequent audit report notes them cleared and closed

• DO NOT HAVE REPEATED FINDINGS YEAR OVER YEAR


www.ftlf.com

BILLING AND COLLECTIONS POLICIES


• Policies and/or procedures for billing and

collection

• Encounter form(s)


• Managed care or any other third party payor

contracts

• Most recent Health Center Program required

financial performance measures/UDS Report


www.ftlf.com

3/25/2016

72


What Are the Requirements?• Must have documentation of participation in Medicaid

and CHIP

• 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

• Must maximize revenue from public and private third party payers – must make every reasonable effort to collect such payments without application of discounts

• Cannot require patients to enroll in insurance – but can and should educate them of benefits


www.ftlf.com


What Are the Requirements? (cont.)• Must make reasonable efforts to bill and collect

from patients in a manner that does not create a barrier to care

• Must establish board-approved policies and procedures that identify circumstances to waive or reduce fees to ensure access

• Apply consistently and uniformly based on defined, board-approved circumstances with specified criteria (such as financial need that does not fit into the SFDS; unusual temporary circumstances that don’t rise to the level of re-assessment of eligibility)

• Define who has authority to make determinations and do not deviate (recommend by title not name)


www.ftlf.com

3/25/2016

73



• May establish board-approved policies to

incentive payment (such as cash/prompt pay

discounts, payment plans, grace periods)

• If this is done, it must be available to all

patients equally regardless of SFDS pay class


www.ftlf.com


What Are the Requirements? (cont.)• May discharge patients for refusal to pay as a last

resort – only after reasonable efforts have been made to secure payments and/or bill for amounts owed to the health center for services provided –board must approve patient discharge policies that include

• Objective criteria only for what constitutes refusal to pay

• Circumstances to be considered in making such determinations

• Collection efforts to be taken prior to discharge, and

• Who can sign off, and documentation standards/internal requirements


www.ftlf.com

3/25/2016

74



• Patient Discharge (cont.)

• May establish related policies for determining how

and when patients may rejoin the regular practice

at a future date

• Remember to consult local counsel regarding

state requirements for patient abandonment and

other contractual/licensure obligations that may

arise


www.ftlf.com


• Billing and collection policies and procedures cannot become a barrier to care or result in denial of care due to inability to pay

• What are “reasonable efforts” to collect?– “Reasonable efforts” may vary based on elements

unique to the health center (such as its target population and location)

• General community versus transient populations

• Rural / sparsely populated versus city / urban


www.ftlf.com


3/25/2016

75

What Are Some Compliance Tips? (cont.)• Collection procedures can include:

– Encouraging some or all up-front payment at time of service (but cannot deny care if patient does not have payment at time of service)

– Follow-up letters and phone calls

– Requiring patients with overdue balances to speak with financial counselor prior to next visit (as long as care is not denied)

– Establishing grace periods and / or payment plans

• Query – should collection procedures be different for nominal fee patients who are at or below FPL??


www.ftlf.com



• Remember: a patient discharge for refusal to pay policy is not a requirement (it’s a “may”)• If a health center is concerned about equitable

application do not institute a discharge for refusal to pay policy

• If the health center institutes this policy, make sure the procedure includes proper review and that all documentation is air-tight before taking the action


www.ftlf.com


3/25/2016

76


www.ftlf.com

151

WAIVER OF CHARGES CRITERIA (ACTUAL LANGUAGE FROM A HEALTH

CENTER THAT PASSED)

• Patients unable to pay will be referred to the following senior

management staff for a determination as to whether the patient may

be seen.

– Director of Clinical Services

– CFO

– CEO

– Medical Director

• To be seen for less than full payment a patient must meet one of the

following conditions:

– Have a condition for which their provider determines it is medically

necessary for them to be presently seen (provider should be consulted if

necessity is at all questionable)

– If partial payment is available, patient must commit to bringing balance

in and PSR will flag account.


www.ftlf.com

152

BUDGET


• Annual budget

• If applicable, operating plan


• Most recent Staffing Profile

3/25/2016

77


www.ftlf.com

153

BUDGET


• Must maintain an annual total

budget/operational budget (including the

section 330 grant) necessary to accomplish the

service delivery plan, including the number of

patients to be served (emphasis added)

• These are for in-scope services

• Further establishes the expectation of taking third-

party revenues into account


www.ftlf.com

154

BUDGET


• Grantees must have budgetary controls in

effect (example: monthly financials that

compare budget to actual) so the health center

will not draw federal funds in excess of

• Total funds authorized on the Notice of Award

• Total funds available in any cost category, if

restricted, on the Notice of Award

3/25/2016

78


www.ftlf.com

155

BUDGET

What Are Some Compliance Tips?• Carefully review PIN 2013-01 – this PIN controls the

establishment of the budget and accounting

requirements of health centers (Note that PINs 94-34

and 95-15 are superseded)

• Since FY 2014, federal dollars must be separated and

accounted for independently of non-federal resources in

the budget and must be tracked accordingly

• Federal cost principles apply to both federal and non-

federal dollars for in-scope activities


www.ftlf.com

156

BUDGET


• Allocation of total budget between 330 funds

and non-grant funds are at health center

discretion (but must meet all HHS policies and

other federal requirements)

• Every 330 dollar must be trackable to ensure

that it has been expended in accordance with

cost principles

3/25/2016

79


www.ftlf.com

157

BUDGET


• Salaries paid to individuals can only use

$185,100 of federal dollars (as of 1/10/16)

• Salary can be higher, but excess must be funded

with program income

• PIN footnote 13 indicates that salaries for

managers and/or providers can exceed the cap if

necessary to remain competitive in hiring qualified

persons

• Not clear for non-manager, non-provider


www.ftlf.com

158

BUDGET


• When using non-grant funds:

• They must be used “…either ’as permitted’ under

Section 330 of ‘for such other purposes ... not

specifically prohibited’ under Section 330 ‘if such

use furthers the objectives of the project.’”

• “Furthering the objectives of the project” is defined

to mean benefiting the health center’s

patient/target population

3/25/2016

80


www.ftlf.com

159

BUDGET


• Income analysis form is part of the budget from a compliance standpoint

• Will be reviewed as to how it was developed and its bearing on program income generation

• Major part of the total budget concept

• The total budget concept is what makes all the in-scope revenues and expenses subject to Section 330 requirements

• Including services performed by referral (more later)


www.ftlf.com

160

BUDGET


• Track grant drawdowns

• Not only totals per month, but also by SF 424 category

(Object Class)

• Report to the board regularly on drawdown progress

(target 1/12 per month or actual expenditures)

• Make sure finance can track every single federal dollar

from the moment of drawdown through expenditure

• Determine if health center needs to re-budget:

• 25% among categories to transfer

• $250,000 cumulative

3/25/2016

81


www.ftlf.com

161

BUDGET

What Are Some Compliance Tips? (cont.)• In addition to regular financial statements, make a quick

report to provide to finance committee and board that

tracks by object class and monitor against month of the

year by percentage

Total Proposed Budget Amount

Section 330 Federal funding (from Total Federal - New or

Revised Budget on Section A – Budget Summary)

Non-Federal funding (from Total Non-Federal - New or

Revised Budget on Section A – Budget Summary)

Total

Budget Categories Object Class Category Federal Non Federal Total (from Section B –

Budget Categories)

a. Personnel b. Fringe Benefits c. Travel d. Equipment

e. Supplies f. Contractual g. Construction h. Other i. Total Direct Charges (sum of a-

h)

j. Indirect Charges k. Total Budget Specified in

Section A - Budget Summary

162


It’s All About the Data


www.ftlf.com

3/25/2016

82


www.ftlf.com

163


• Most recent UDS report and UDS Health Center

Trend Report

• Most recent Clinical and Financial Performance

Measures Forms

• Clinical and financial information systems (e.g.,

EHR, practice management systems, billing

systems)

PROGRAM DATA REPORTING SYSTEMS


www.ftlf.com

164



• Health center must have systems in place that

• Accurately collect and organize data for program

monitoring

• Support management decision-making

• Looks at the quality and usability of the data in

the EHR, Practice Management system, the

financial reports, etc.

• Also investigates what kind of information the

board and management team is reviewing

3/25/2016

83


www.ftlf.com

165


• 45 CFR 75.342: HRSA has authority to require

regular monitoring reports, and also this section

grants the authority to make OSVs

• UDS

• FFR

• Clinical and Financial performance measures

• Other reporting requirements (like supplemental

funding)



www.ftlf.com

166


• Are these items available, trustworthy, and

based on good data inputs?

• Does the organization use information from

ongoing data reporting and needs assessments

to support decision-making?


3/25/2016

84


www.ftlf.com

167



• Health centers should make sure that they can

trace the elements in their required reports back

to their data sources

• In terms of clinical quality data, can the QI team

point to exactly which EHR fields drive the

numerators and denominators in the item?

• What are the subsidiary schedules in financial

reports that feed the FFR?


www.ftlf.com

168



• How does the health center use data in

decision-making?

• How often does the management team and board

review needs assessments?

• How does accuracy of reports feed the decision-

making of the management and board?

3/25/2016

85


www.ftlf.com

169



• Coming all the way back to PR#1 – how does that

needs assessment get updated, based on data,

so that the health center makes decisions like:

• Adding providers

• Adding sites

• Moving sites

• Extending services

• Entering into partnerships

• Arranging for additional enabling services


www.ftlf.com

170



• In terms of financial data:

• Are estimates of accounts receivable accurate

(and properly reserved against) so as not to distort

the asset base of the health center?

• Can the health center make sure that the staff and

board are not unrealistically viewing the financial

state of the organization?

• This ties in with the GAAP accounting requirements and

the use of the accrual method

3/25/2016

86

171


Bringing This All Together Under Scope of

Project


www.ftlf.com

172

SCOPE: A VISUALIZATION

Services

Service

Area

Target Population Providers


www.ftlf.com

3/25/2016

87

173

BASICS OF SCOPE

• Five elements together define the health center’s scope

• Defines the activities supported under the total

approved section 330-grant related project budget

(federal funds, program income and other funds) or

Look-Alike designation

• Defines the activities for which scope-related benefits

are available (check specific rules for those benefits for

exceptions)

• Defines the activities to which scope-related

requirements apply


www.ftlf.com

174

SCOPE-RELATED BENEFITS

• Fair reimbursement under Medicare/Medicaid

• 340B discount drug pricing program

• Medicare reimbursement for "first dollar" of services rendered to beneficiaries, i.e., deductible is waived

• Providers through National Health Service Corps

• Vaccine For Children program and eligibility to participate in the Pfizer Sharing the Care Program

• Federal Tort Claims Act coverage (grantees only)

• Expansion grants and federal loan guarantees (grantees only)

• Anti-kickback safe harbor for certain arrangements with other providers or suppliers of goods, services, donations, loans, etc. (grantees only)


www.ftlf.com

3/25/2016

88

175

SCOPE-RELATED REQUIREMENTS

• Established/approved by the board

• Available and accessible equally to all service area residents and to all lifecycles (not all services must be available at all sites)

• Offered at a discount to all patients at or below 200% FPL, regardless of mode of delivery (can use federal funds to support such discounts, even if provided by referral)

• Offered in culturally and linguistically appropriate manner

• Provided consistent with center’s policies/procedures

• Reported in grant application and scope forms

• Controlled by the center, which is legally responsible


www.ftlf.com

176

IF OUT OF SCOPE

• The programmatic requirements will not apply …

BUT

• You cannot support the activity with 330 funds or program income pledged to 330 project

AND

• With some exceptions, you cannot utilize the benefits from the previous slides


www.ftlf.com

3/25/2016

89


www.ftlf.com

177

ELEMENTS OF SCOPE

• Services: required and additional services listed on Form 5A (see PR #2)

• Must be provided directly or by established written arrangement (contract or referral)

• Formal procedures for providing in-scope services by formal written contract / referral (see PR #10)

• NOTE: “making a referral” is not the same as “providing a service by referral”

• Referrals are part of continuity of care under general primary health care – you are not providing a service by referral unless you list that service on Form 5A, column III


www.ftlf.com

178

ELEMENTS OF SCOPE

• Sites: locations at which services are provided

to a defined service area or target population

• Permanent, seasonal, intermittent, mobile vans

• Must meet all of the following conditions:

• Visits are documented in a patient’s medical

record

• Providers exercise independent judgment

• Services are provided directly by or on behalf of

center and board retains control and authority

• Services are provided on a regularly scheduled

basis

3/25/2016

90


www.ftlf.com

179

ELEMENTS OF SCOPE

• Providers: individual health care professionals who provide services on behalf of health center, exercise independent judgment and document services in the patient’s record

• Directly employed, contract with individual providers or contracts with other organizations

• Must be properly credentialed and licensed to perform the activities and procedures expected of them by the health center (see PR #3)

• TIP: better to not keep a specific provider “out of scope” within the health center - too complex to manage and fraught with risk, in the event of an unexpected outcome


www.ftlf.com

180

ELEMENTS OF SCOPE

• Service Area: geographic area served by the health center

• Area in which the majority of the health center’s patients reside

• Must be reviewed periodically (see PR #1)

• Must be federally designated as a Medically Underserved Area in full or in part or contain a federally designated Medically Underserved Population (MUP)

• HOWEVER, most health centers serve everyone who presents for care (at least when they come the first time)

3/25/2016

91


www.ftlf.com

181

ELEMENTS OF SCOPE

• Target Population: medically underserved population to be served

• Usually a subset of the service area population

• May be a special population: migrant or seasonal farmworkers, homeless individuals, residents of public housing

• Cannot be exclusively a single age group/range, gender, race, ethnicity

• Restricting services to a certain target population is rare as well (exceptions for services to special populations)

SCOPE OF PROJECT


• Health Center UDS Trend Report

• Health center’s official scope of project for sites and services ( Forms 5A, 5B, and 5C)

• Most Recent Form 2 Staffing Profile

• Notice of Award and information for any recent New Access Point or other supplemental grant awards


www.ftlf.com

3/25/2016

92

SCOPE OF PROJECT


• Must maintain funded scope of project (sites, services, service area, target population, and providers), including any increases based on recent grant awards

• Scope must reflect all services/activities health center is actually providing and where those services/activities are provided – must maintain accurate and up to date Forms 5A, 5B, 5C


www.ftlf.com

SCOPE OF PROJECT


• Scope must reflect all services/activities health center is currently providing and where those services/activities are currently provided

• Scope should not reflect what health center intends to due at a future date


www.ftlf.com

3/25/2016

93

SCOPE OF PROJECT

What Are Some Compliance Tips? (cont.)• Conduct ongoing review of scope (Forms 5A-C

in Electronic Handbook) • If there are inaccuracies on scope forms,

contact project officer and correct promptly –timing is essential!

• Review mode of delivery as well as the actual services

• Don’t forget operational dates and Medicare site certification for all sites

• Use scope-related guidance on BPHC website http://www.bphc.hrsa.gov/programrequirements/scope.html


www.ftlf.com

186

SCOPE OF PROJECT

What Are Some Compliance Tips – Form 5A? (cont.)

• Type of service• Required Services – must be provided by every

health center, either directly or by established arrangement

• Additional Services (optional) – may be provided, based on need and other relevant factors, as long as required services are not adversely impacted; typically reflect common additional service

categories provided by health centers


www.ftlf.com

http://www.bphc.hrsa.gov/programrequirements/scope.html

3/25/2016

94

187

SCOPE OF PROJECT

What Are Some Compliance Tips – Form 5A? (cont.)

• Type of service (cont.)• Specialty Services (optional) – subset of

Additional Services - only the specific service described in CIS request (not category) will be in scope; must support and be related to primary care provided


www.ftlf.com

188

SCOPE OF PROJECT

What Are Some Compliance Tips – Form

5A? (cont.)

• Mode of Delivery• Directly through health center staff – always in

scope

• Formal written contract – always in scope

• Formal written referral arrangement –arrangement is in scope but not the service itself


www.ftlf.com

3/25/2016

95

189

SCOPE OF PROJECT

What Are Some Compliance Tips – Form 5A? (cont.)• What’s not included on Form 5A? Informal

referral arrangements – not in scope BUT part of continuum of care

• The “golden rule”• If a service / referral arrangement is not listed on

Form 5A it is not in scope and requirements / benefits do not apply

• Conversely, anything listed on Form 5A (regardless of type of service or mode of delivery) is included in scope and requirements / benefits apply


www.ftlf.com

190

SCOPE OF PROJECT

What Are Some Compliance Tips – Form 5A? (cont.) • Service Descriptor Guide

• For each required service: (1) minimum elements of the service; (2) what also may be included; and (3) what is not included (would require separate CIS)

• For “pre-populated” additional services: (1) what may be included; and (2) what is not included (would require separate CIS)

• Column Descriptor Guide• For each mode of delivery, provides key elements

and distinctions


www.ftlf.com

3/25/2016

96

191

SCOPE OF PROJECT

What Are Some Compliance Tips – Form 5B? • Site Type

• Service Delivery Sites –visits are generated, providers exercise independent judgment, andservices are provided directly or on behalf of the health center (column I/II) on a regularly scheduled basis (must meet all elements)

• Administrative Sites – non-clinical services are provided and/or administrative work is performed

• Service Delivery/Administrative Sites –meet service delivery definition and at which administrative work is performed


www.ftlf.com

SCOPE OF PROJECT


• If health center was awarded additional funding in last 3 years that resulted in expanded scope (e.g., NAP funds), must ensure

• Newly funded activities were (or will be) implemented within required timeframe

• Projected goals (patients, encounters, etc.) are met


www.ftlf.com

3/25/2016

97

SCOPE OF PROJECT


• If restricting scope on any manner, conduct

significant risk management and training to make

sure limitations are applied consistently, fairly, and

in line with health centers’ main responsibility not to

erect barriers to access to care

• Ensure appropriate segregation of out-of-scope

activities from in-scope activities (cannot use 330

funds or grant-related resources and FQHC

benefits will not apply) - must think strategically

regarding in-scope versus out-of-scope


www.ftlf.com

194

Assessing Compliance with the

Nineteen Requirements

Tips for the HRSA Operational Site Visit


www.ftlf.com

3/25/2016

98

OPERATIONAL SITE VISIT 101: BASICS

• On-site audit of a health center’s compliance with 19 Health Center Program Requirements

• 3-day OSV at least once per project period

• Review team comprised of three HRSA consultants – not HRSA employees

• Project Officer and/or other BPHC staff, as well as PCA representative, may be at the review to “observe”

• Process is designed to ensure review is based on objective program requirements

• No gray areas or “partial” compliance – center is either compliant or not compliant at the time of the OSV


www.ftlf.com

OPERATIONAL SITE VISIT 101: BASICS

• Health Center Site Visit Guide = main (but not only) review instrument – includes:

• Standardized, objective questions

• List of documents that will be assessed

• List of legal authorities for each requirement

• Uniform site visit format and outcomes

• Site Visit Guide DOES NOT include performance improvement assessments for each requirement; reviewers can offer “recommendations” as long as they are not included in official compliance report

• Report is final and findings of non-compliance will result in grant conditions

• Average health center gets between 3-7 conditions


www.ftlf.com

3/25/2016

99

POTENTIAL CONSEQUENCES

• Special award conditions related to findings of non-compliance

• If significant number of conditions, or if conditions are unresolved within appropriate timeframes, may face:

• Ineligibility to apply for certain expansion grants• One year project period for Service Area Competition

(competitive project renewal)• “High-risk” designation• Cost disallowances• Draw-down restrictions• Suspension/termination of funding

• Ultimately, could result in re-competition of your grant

• Any other remedies legally available and appropriate


www.ftlf.com

COMMON MYTHS

• Myth #1: the OSV process is intended to be a punitive process

• While not “punitive” by nature, the process isintended to determine compliance and should be taken seriously

• Myth #2: the review teams are supposed to find something, regardless of whether non-compliance exists

• HRSA has explicitly instructed reviewers not to find something just for the sake of doing so

• However, old habits may be hard to break!


www.ftlf.com

3/25/2016

100

COMMON MYTHS

• Myth #3: the process is bias towards “certain” health centers – it’s who you know and not what you do that counts

• Formal bias based on the identity of the health center should not exist

• However, the reputation of a health center may come into play

• Further, a health center that is professional and knowledgeable, and presents a well-organized and efficient operation, starts off on a “good foot,” which may help during the review


www.ftlf.com

COMMON MYTHS

• Myth #4: you should not argue with the

reviewers – it will reflect poorly on the

report

• While “arguing” and getting defensive is

never a good approach, if you believe that

a finding is inaccurate, it is best to talk it

out with the reviewer while he/she is still

on-site, without fear of negative

repercussions – may be able to make

change at that time!


www.ftlf.com

3/25/2016

101

PRE-SITE VISIT ACTIVITIES

• HRSA consulting group assigns a review team

• Project Officer and the review team contact the health center to determine logistics/agenda

• Health center provides data and information to the review team, which conducts preliminary analysis of documents


www.ftlf.com


• What can you do before the OSV?

• START EARLY!!! Conduct internal review

• Discuss the review and prepare all management, staff and board members

• Ensure that everyone is on the same page regarding the health center’s governance and operations

• Identify point person(s) for each area, as well as overall point person

• Ensure that you meet deadlines for sending documents to the review team


www.ftlf.com

3/25/2016

102


• What can you do before the OSV? (cont.)• Review the Health Center Site Visit Guide

• Review all of the questions – run through samples and work on best answers - don’t let review questions take you by surprise

• Include all key staff – not just management

• Don’t assume the reviewers are or will be “experts” about your community or that they understand your specific program’s operations

• Prepare overview for entrance conference that highlights what you want to highlight

• Include your current strengths and future plan


www.ftlf.com

ON-SITE ACTIVITIES

• Entrance conference: review team provides overview of assessment and health center provides overview of organization

• Review team visits one or more sites, conducts on-site assessment of documents, and interviews staff and board members to determine compliance

• End of each day, review team meets with CEO to discuss preliminary findings

• Exit conference: review team discusses findings and health center is afforded opportunity to question findings and clarify details


www.ftlf.com

3/25/2016

103

ON-SITE ACTIVITIES

• What can you do during the OSV?• Put your best foot forward at all times

(including telling your strengths)

• Ask questions while the review team is on-site & don’t miss opportunities to clarify or add something that you forgot

• Make sure that you are answering the questions that are asked• Don’t go off on tangents

• Be accurate

• Focus your responses on the keys to the question

• Ask the reviewer to clarify or be more specific when necessary


www.ftlf.com

ON-SITE ACTIVITIES

• What can you do during the OSV? (cont.)

• Have accessible, accurate, easy-to-understand information available • Keep documentation for certain areas together in folders

/ binders / flash drives

• Don’t make the reviewers dig for information

• Actively provide information to reviewers throughout the review

• During exit interview, ask for rationale behind proposed findings – and don’t let the reviewers leave unless all findings are discussed, all issues are clarified, and all health center questions are answered


www.ftlf.com

3/25/2016

104

POST-SITE VISIT ACTIVITIES

• Review team drafts report and sends to consulting firm within 5 days of the exit conference

• Consulting firm reviews report and forwards to HRSA

• HRSA reviews and if necessary revises the report; revised report is finalized and sent to health center –should take 45 days, but may take longer if there is disagreement about findings

• HRSA issues NoA with conditions based on non-compliance findings

• Health center typically has 90 days from the NoA date to respond to NoA conditions (not report findings) –demonstrate either actual compliance or a plan to become compliant within 120 days


www.ftlf.com


• What can you do after the OSV?

• If you disagree with one or more findings of non-compliance discussed at the exit interview, and you are unable to either make change while reviewers are on-site or convince reviewers otherwise, contact your Project Officer immediately to discuss before final

• Review report as soon as it arrives

• If you disagree with one or more findings of non-compliance in the report, contact your Project Officer immediately

• Start to prepare responses to non-compliance (“not met”) findings, even if you disagree with them


www.ftlf.com

3/25/2016

105


• What can you do after the OSV? (cont.)• Upon receipt of the NoA from HRSA, review the

grant conditions – ensure all conditions are consistent with the review team’s findings of non-compliance and are based on legal requirements rather than areas of performance improvement

• Develop official response to grant conditions that are based on non-compliance findings

• Submit the response within the allotted time period


www.ftlf.com


www.ftlf.com

210

Warren J. Brodine, PresidentW. J. Brodine & Co.

[email protected]

(312) 402-0272

Marcie H. Zakheim, Esq., PartnerFeldesman Tucker Leifer Fidell LLP

[email protected] 20th Street N.W. – Suite 400

Washington, D.C. 20036(202) 466-8960

www.ftlf.com

QUESTIONS??

mailto:[email protected]

mailto:[email protected]

http://www.ftlf.com/