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A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud” E. DeLoss Popovits & Robinson [email protected] (708) 479-3230 Popovits & Robinson 1

A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

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Page 1: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

A Local Health Department and Federally Qualified Health Center: The Public Entity

Ninth Annual Rural Public Health InstituteMarch 5-7, 2013

Gerald “Jud” E. DeLossPopovits & [email protected]

(708) 479-3230

1

Page 2: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Legal Issues Confronting the FQHC andPublic Health Department

Popovits & Robinson 2

Page 3: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Federal Tort Claims Act

o Under the Public Health Service Act, employees of eligible FQHCs may be deemed to be federal employees qualified for protection under the FTCA

o There is no cost to participating FQHCs or their providers, and they are not liable for any settlements or judgments

o The FQHC, their employees, and eligible contractors are considered federal employees immune from suit for medical malpractice claims while acting within the scope of their employment

Popovits & Robinson 3

Page 4: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

Federal Tort Claims Act

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oDeemed FQHC grantees are immune from medical malpractice lawsuits resulting from:o Medicalo Surgicalo Dentalo Related functionso Within the approved scope of project

Page 5: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

Federal Tort Claims Act

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o Eligible FQHCs must submit an original deeming and annual renewal deeming applications

o A patient who alleges acts of medical malpractice by a deemed FQHC cannot sue the center or the provider directly, but must file the claim against the US Government

o These claims are reviewed and/or litigated by HHS Office of the General Counsel and DOJ

Page 6: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

FTCA - Eligibility

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o FTCA Grantees eligible to be deemed are:o Community Health Centers (CHC)o Migrant Health Centers (MHC)o Health Care for the Homeless (HCH) Health Centerso Public Housing Primary Care (PHPC) Health Centerso Subrecipients eligible for FTCA coverage

Page 7: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

FTCA - Subrecipient

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o What is a subrecipient?o Defined as an entity (not an individual contractor) that receives

a grant or a contract from a deemed FQHCo Provides the full range of health services on behalf of the

deemed FQHCo Only for those services under the scope of the project

o Contractual relationships with other entities for individual services (e.g., laboratory, pharmacy, physician services) are not subject to FTCA coverage

Page 8: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

FTCA - Coverage

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o FTCA is only available for:o FQHCo Full or part-time FQHC employeeso Individually contracted providers who furnish services in the

fields of:o General internal medicineo Family practiceo General pediatricso OB/GYN

o Individually contracted providers who furnish services in other fields of practices on full-time basis

o A contract between a FQHC and a provider's corporation does not confer FTCA coverage on the provider

Page 9: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

FTCA - Coverage

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o Coverage/Protection for Covered individualso FTCA similar to occurrence insurance policyo Do not need to purchase tail coverage

o Non-Covered Individualso Individuals who do not meet the statutory requirements for

covered individualso Examples include:

o Volunteer physicianso Part-time (less than 32.5 hours) contract dentists

o The FQHC remains covered, while the individual is not

Page 10: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

FTCA – Specific Situations

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o Indemnification of Other Entitieso FTCA coverage does not extend to

indemnification or hold harmless of other entities

oGoverning Board Members and Officerso The governing board members and officers are

covered under the FTCA only for medical malpractice

Page 11: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

FTCA - Coverage

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o Covered Activitieso FTCA coverage is restricted to scope of employmento For actions to be within the scope of employment, they must

occur during the provision of services to the FQHC’s patients and, in certain circumstances, to non-FQHC patients

o The FQHC is responsible to maintain current records

Page 12: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

FTCA - Coverage

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o Scope of Employmento Includes performance under a contracto All covered individuals should have current, written job

descriptionso FTCA matters may come to litigation, so job descriptions play

a key role in demonstrating scope of employment and FTCA coverage

o Moonlighting is not within the scope of project

Page 13: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

FTCA - Coverage

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o Scope of Projecto FTCA coverage is limited to the performance of medical,

surgical, dental, or related functionso New services and sites are dependent on approval of a

change in the scope of the project

o A request for a change in scope should be submitted to HRSA/BPHC for approval

Page 14: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

FTCA - Coverage

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o Services to FQHC Patientso A patient-provider relationship must be established

o For purposes of FTCA coverage, the patient-provider relationship is established when:o Individuals access care for initial or follow-up visits at

approved siteso Individuals access care at approved sites even if not

permanent residentso Triage services are provided by telephone or in person, even if

patient is not yet registered but is intended to be registered

Page 15: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

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FTCA – Coverage

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o FTCA coverage for services to non-FQHC patients is available in certain situations

o Examples of Covered Services to Non-FQHC Patients:o Community-Wide Intervention School-Based Clinicso School-Linked Clinicso Health Fairs

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FTCA – Particularized Determination

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o Other examples of Covered Services to Non-FQHC Patients:o Immunization Campaignso Migrant Camp Outreacho Homeless Outreacho Hospital-Related Activitieso Coverage-Related Activities

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Popovits & Robinson

FTCA – Particularized Determination

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o Acts and omissions related to services for non-FQHC patients may be covered if approved particularized determination of FTCA coverage

o The application for a particularized determination must provide:o Services to non-FQHC patients will benefit FQHC patients and

general populationso Services to non-FQHC patients facilitates the provision of

services to FQHC patientso Such services are otherwise contractually-required

o Request for a particularized determination of FTCA coverage must include sufficient detail

Page 18: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

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FTCA - Coverage

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o Continuity of careo Covered individual may follow FQHC patient to non-FQHC site

to maintain continuity of care

o Supervision of non-FQHC staffo Supervision of Students and Medical Residentso Activities under other grant fundingo Clinical researcho Assisting with community events

Page 19: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

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FTCA – Coverage Under Alternate Billing

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o FQHC providers may bill directly for services provided to FQHC facility patients

o If employee or contract provider, meeting all other FTCA requirements bills for a service delivered at a location not within its scope of project, FTCA coverage will apply to the provider

Page 20: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

FTCA – Coverage in Emergencies

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o Emergency situationso FTCA coverage will apply to the performance of

medical, surgical, dental, or related functions at temporary locations

o If covered individuals volunteer in their individual capacity to respond to an emergency, they will not be protected under FTCA

o Patients served by covered individuals at temporary locations are considered the FQHC’s patients

Page 21: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

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FTCA – Coverage in Emergencies

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o In rare cases emergency may impact an entire region or State

o If site of FQHC in the impacted area is destroyed or unable to operate, FQHC may submit a request for prior approval to temporarily change its scope of project

o If covered individuals volunteer in their individual capacity to respond to an emergency they will not be protected under FTCA

Page 22: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

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FTCA – Coverage in Emergencies

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o In emergency situations, FQHCs that are not directly impacted by the emergency may:o Assist at temporary sites within the FQHC’s own service

area and within neighboring counties, parishes, or political subdivisions

o Operate temporary sites within the service area and within neighboring counties, parishes, or political subdivisions by including the temporary locations within the scope of project

Page 23: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

FTCA – Public Health Department

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oFTCA coverage is available only to the FQHC and individuals identified above

oCannot be extended to the Health Department or its employeeso Unless they are individually contracted to

the FQHCo Satisfy the above-mentioned criteria for

individual coverage

Page 24: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

FTCA – Acceptance by Hospitals andManaged Care Plans

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o Covered individual cannot be denied hospital privileges solely because malpractice protection is FTCA

o Managed care plans, including HMOs and similar entities, must accept FTCA coverage as meeting malpractice insurance coverage requirements

o Hospitals or managed care plans that fail to comply in jeopardy of losing ability to collect payment under Medicare and Medicaid

Page 25: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

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FTCA - Insurance

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o FQHC has option to meet malpractice liability through FTCA or private insuranceo FQHCs not applied for, or have terminated FTCA, may use Federal grant funds

for private malpractice insuranceo Dual coverage (i.e., both FTCA and private malpractice insurance covering the

same activities) is not permittedo US Government may subrogate claims where FQHC has private coverage and

payment is made under FTCAo Gap Coverage non-covered activities or non-covered individualso Even with FTCA coverage, FQHCs will continue to need other types of insurance:

o Non-medical/dental professional liability coverageo General liability coverageo D & O coverageo Automobile and collisiono Fire and theft coverage

o FQHC applying for initial FTCA deeming, should have private malpractice insurance in place until deemed

Page 26: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

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FTCA – Legal Claim Procedure

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Page 27: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

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FTCA – Legal Claim Procedure

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o Statute of Limitationso Claim must be presented within two years after the

claim accrueso Generally, accrual occurs on the date of the injuryo However, also incorporates a discovery ruleo State statute of limitations periods do not apply to

claims filed under the FTCA.

Page 28: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

FTCA - Deeming

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o To be deemed, a grantee or subrecipient must complete an application that demonstrates that it:o Risk management policies and procedureso Credentialing and privileging systemo Has no history of claims or, if such a history exists, has fully

cooperated with DOJo Cooperate to provide information related to a claim

Page 29: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

FTCA – Deeming Process Tips

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o Deeming applicants must:o Submit FTCA application materials in a timely mannero Respond in a timely manner to all requests from HRSAo Demonstrate implementation of the required policieso Accurately present all material facts

o HRSA’s goal to support all FQHCs in successfully demonstrating compliance with and implementation of these requirements

Page 30: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

FTCA – Deeming Process Tips

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o Due to the number of applications, application requirements, and potential for incomplete application submissions, grantees should request FTCA coverage at least 90 days in advance

o HRSA will conduct its review within 30 dayso If additional information or clarification is needed, HRSA

will notify the grantee through the EHB, and the grantee will be given 10 business days to provide the requested information

o Should the requested information not be submitted within 10 business days of notification, the applicant will be required to submit a new application

Page 31: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

FTCA – Additional Requirements

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o Health Center policies and procedures for the following must be included:o Referral trackingo Hospitalization trackingo Diagnostic tracking

o Statement verifying that any professional liability claims were internally analyzed

o Statement should include the following for each claim filed within the last five years:o Name of provider(s) involvedo Area of practice/Specialtyo Date of occurrenceo Summary of allegationso Status and outcome of claim

Page 32: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

FTCA – Additional Requirements

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o Electronic Signature of the Executive Directoro Deeming Applications for any subrecipient(s)

o Considered part of the deeming application of the grantee

o Deeming applications by eligible entities must be submitted in the form and manner prescribed by HRSA and must demonstrate that the entity seeking FTCA coverage has successfully implemented all deeming requirements set forth in law

Page 33: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

FTCA – Annual Renewal

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o All currently deemed grantees must submit a FTCA renewal application for themselves and any subrecipients

o If additional information or clarification is needed to support the application, HRSA will notify the grantee and the grantee will be given ten (10) business days to provide the additional information

Page 34: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

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FTCA – Site Visits

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o HRSA may elect to conduct a site visit at any point during the application review process and/or as part of its oversight responsibilities

o Factors that may prompt a site visit include, but are not limited to:o Submission of an initial FTCA deeming applicationo Unresolved questions identified during the review of the FQHC’s

applicationo Need for follow-up based on prior site visit findings or other

identified issueso History of repeated pertinent conditionso History of claims

Page 35: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

FTCA – Site Visits

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o Site visit reviewers will assess whether applicant:o Risk management policies and procedureso Credentialed and privileged its physicians and other licensed

or certified health care practitionerso Has history of claims, then may validate that the grantee has

fully cooperated with the Attorney General in defending against any such claims and has taken necessary corrective steps to assure against future claims

Page 36: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

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FTCA - Risk Management

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o PHS Act requires as condition of deeming, to determine that the entity has implemented “appropriate policies and procedures to reduce the risk of malpractice and the risk of lawsuits arising out of any health or health-related functions performed by the entity

Page 37: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

Risk Management Program

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oRisk management program is critical:o Promote safe and effective patient care practiceso Maintain a safe working environmento Protect FQHC’s financial resources

Page 38: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

Risk Management Program

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oEffective program can:o Identify and mitigate liability exposureso Prevent and reduce the severity of adverse

eventso Improve patient experienceo Increase provider and staff satisfaction

Page 39: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

Risk Management Program

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o Value to FQHC:o Secure commitment to improveo Review injuries, adverse events, and near misses to prevent

re-occurrenceo Promote system improvemento Reduce liability exposureo Encourage open communication among providers and staffo Establish a culture of safety

Page 40: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

Risk Management Program

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o Key principles of the program include:o Claims managemento Complaint resolutiono Confidentiality and release of patient informationo Event investigation, root-cause analysis, and follow-upo Failure mode and effects analysiso Provider and staff education, competency validation, and

credentialing requirementso Reporting and management of adverse events and near

misseso Trend analysis of events, near misses, and claims

Page 41: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

Risk Management Program

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o Risk management program should be administered through the Risk Manager who reports to the administrator/CEO

o Risk Manager should interact with administration, staff, medical providers, and other professionals

o Risk Manager should chair the Risk Management Committee

Page 42: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

FTCA – Credentialing and Privileging

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o Entity must review and verify “the professional credentials, references, claims history, fitness, professional review organization findings, and license status of its physicians and other licensed or certified health care practitioners ….”

Page 43: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

FTCA – Credentialing Details

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o Credentialing of Licensed Independent Practitioners (LIPs) requires primary source verification of:o Current licensureo Relevant education, training, or experienceo Current competenceo Health fitness, or the ability to perform the requested privileges

o Credentialing of LIPs requires secondary source verification of:o Government issued IDo DEA registrationo Hospital privilegeso Immunization and PPD statuso Life support trainingo Query of the National Practitioner Data Bank (NPDB)

o Determination that LIP meets credentialing requirements by FQHC’s governing board

Page 44: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

FTCA – Credentialing Details

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o Credentialing of other health care practitioners requires primary source verification of:o License, registration, or certificationo Education and training may be verified by secondary source verificationo Verification of current competence through review of clinical

qualifications and performance

o Credentialing of other health care practitioners requires secondary source verification of the following:o Government issued IDo Immunization and PPD statuso DEA registrationo Hospital admitting privilegeso Life support training

Page 45: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

FTCA – Credentialing and Privileging

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o Licensed and certified staff members at all FQHC sites including employed or contracted practitioners, volunteers and locum tenems, must include evidence of credentialing and privileging within the last two years

o Credentialing list must include the following:o Name and Professional Designation (e.g., MD/DO, RN, CNM, DDS, LPN,

PA, MA, NP, etc.)o Title/Positiono Specialtyo Employment Status (full-time employee, part-time employee, contractor or

volunteer)o Hire Dateo Current Credentialing Date (must be within past two years)o Next Expected Credentialing Date (if known)

Page 46: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

FTCA - Privileging

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o Revision or renewal of a privileges at least every 2 yearso Include synopsis of peer review results for the 2 year period

and/or any relevant performance improvement informationo Approval of subsequent privileges vested in the boardo The FQHC should have an appeal process LIPso Appeal process is optional for other licensed or certified

health care practitioners.o NOTE: FTCA requirements may not be the same as

accreditation-related standardso FQHCs that are accredited or seeking accreditation should also review

the applicable accreditation body standards

Page 47: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

Credentialing & Privileging - Board

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o FQHC’s credentialing and privileging policies and procedures must include documentation of Board approval

o Credentialing and privileging policies and procedures must be approved, signed and dated by the Board

Page 48: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

FTCA - Quality Improvement/Quality Assurance

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o Initial or renewal application must contain Quality Improvement/Quality Assurance (QI/QA) Plano Clear documentation that the Board reviewed and approved

the plan within three (3) years of the date of submissiono QI/QA plan must be approved, dated, and contain the

appropriate signature(s) of the Board of Directors

Page 49: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

FTCA - Quality Improvement/Quality Assurance

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o Minutes from any six Board meetings evidencing oversight of QI/QA activities - must provide an explanation if less than six sets of minutes are provided

Page 50: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

Quality Improvement/Quality Assurance

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o FQHC has an ongoing Quality Improvement/Quality Assurance (QI/QA) which must include: o Clinical directoro Periodic assessment of the appropriateness of the utilization of

services and the quality of services providedo Conducted by physicians or by other licensed health

professionals under the supervision of physicianso Based on the systematic collection and evaluation of patient

records o Identify and document the necessity for change in the

provision of services by the FQHC

Page 51: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

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Quality Improvement/Quality Assurance

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o The clinical director must have clear responsibility for conducting QI/QA assessments/activitieso May be full or part time staff, and should have appropriate

training/background (MD, RN, MPH, etc.), as determined by the needs/size of the FQHC

o Plan must measure and evaluate patient satisfaction o The FQHC must have clinical information systems in

place for key performance datao The findings of the QI/QA process are used to

improve organizational performance

Page 52: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

State Tort Immunity

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o Illinois provides limited immunity from tort lawsuitso Local Governmental and Governmental Employees

Tort Immunity Acto Provides for coverage for medical facilities, public

health clinic, and physicianso Coverage available for certain injuries and claimso Each entity must make its own specific determination

of whether it falls under the protections of the Act and/or whether the FQHC/Health Department is immunized for its actions/inactions

Page 53: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

State Tort Immunity

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o Many public and local hospitals and medical centers are protected from medical malpractice claims by the Act

o Generally, failure to diagnose or treat a patient at a public health facility is immunized by the Act

o However, public medical personnel and entities are not immune from:o Negligently or wrongfully prescribing treatmento Negligence, wrongful act, or omission in administering the prescribed

treatment

o The Act may not immunize actions or omissions by “independent contractors”, who are not deemed “employees”

Page 54: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

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Governance

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o Organizations must have a governing body which assumes full authority and oversight responsibility for the FQHC

o The governing board must maintain an acceptable size, composition, and meeting schedule

o The board must have the authority to control the FQHC's budget and major resource decisions, set center policies, and approve the selection and dismissal of the FQHC program director or chief executive officer

Page 55: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

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Governance

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o FQHC must have governing body which:o Meets at least once a month, selects the services to be

provided by the center, schedules the hours during which services will be provided, approves the center's annual budget, approves the selection of a director for the center, and, except in the case of a public center (as defined in the second sentence of this paragraph), establishes general policy for the center

o In the case of the application for a second or subsequent grant for a public center, has approved the application or, if the governing body has not approved the application, the failure of the governing body to approve the application was unreasonable

Page 56: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

Popovits & Robinson

Governance – Public Entities

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o Public entities operating FQHC programs may meet the governance requirement in either of two wayso The public entity's board may meet FQHC board composition

requirements including having a consumer majorityo When the public entity's board does not meet FQHC composition

requirements, a separate FQHC governing board may be established

o FQHC board can be a formally incorporated entity and it and the public entity board are co-applicants for the FQHC program

o When there are two boards, each board's responsibilities must be specified in writing so that the responsibilities for carrying out the governance functions are clearly understood.

o Upon showing of good cause the Secretary may waive all or part of the requirements

Page 57: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

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Governance

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o Public centers with co-applicant boards must meet all the membership requirements and perform all the responsibilities expected of governing boards

o Except co-applicant board is permitted to retain authority for establishing general policies (fiscal and personnel policies)

Page 58: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

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Governance

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o FQHC’s board:o Meets monthlyo FQHCs with approved waivers ONLY may have appropriate

strategies in place to ensure regular oversight, if the board does not meet monthly

o Reviews and approves the annual FQHC (renewal) application and budget

o Conducts an annual review of the CEO’s performance

Page 59: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

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Governance

59

o FQHC’s board:o Reviews and approves the services to be provided and the

FQHC’s hours of operationo Measures and evaluates the FQHC’s progress in meeting

annual and long term clinical and financial goalso Engages in strategic and/or long term planning for the FQHC

Page 60: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

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Governance

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o FQHC’s board:o Reviews mission and bylaws on a periodic basiso Receives appropriate information that enables it to evaluate

FQHC patient satisfaction, organizational assets, and performance

o Establishes the general policies, including:o Personnelo Health careo Fiscal and quality assurance/improvemento With the exception of fiscal and personnel policies in the case of a

public agency grantee in a co-applicant arrangement

Page 61: A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Institute March 5-7, 2013 Gerald “Jud”

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Governance - Public Health Department

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o For Public Center Grantees with Co-Applicant Arrangements only—Public center grantee has a formal co-applicant agreement:o Roles, responsibilities, and the delegation of authoritieso Any shared/split responsibilities between the public center and

co-applicant board

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o The FQHC 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

o Governing board has at least 9 but no more than 25 members

o The remaining non-consumer members of the board shall be representative of the community

o No more than one half (50%) of the non-consumer board members may derive more than 10% of their annual income from the health care industry

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o A majority (at least 51%) of the board members receive services (i.e., are patients) at the FQHC

o There is no established ratio for board members to population served; however, board composition must be reasonably representative of the populations being served

o FQHCs with approved waivers only–appropriate strategies are in place to ensure consumer/patient participation and input from the target population

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o FQHC bylaws or written corporate board approved policy include provisions that prohibit conflict of interest by board members, employees, consultants, and those who furnish goods or services

o No board member shall be an employee of the FQHC or an immediate family member of an employee

o CEO may serve only as a non-voting ex-officio member of the board

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o The FQHC’s conflict of interest policy must address: o Disclosure of business and personal relationships, including

nepotismo Extent to which a board member can participate in board

decisions where the member has a personal or financial interesto Using board members to provide services to the center o Expense reimbursement policies o Acceptance of gifts and gratuities o Personal political activities of board memberso Consequences for violating the conflict policyo Written standards of conduct governing the performance of its

employees engaged in the award and administration of contracts

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o Options to assist the FQHC in its assessment of health service needs of special populations:o Inclusion on the board of persons who previously have been

FQHC consumers, but no longer receive serviceso Use of an advisory boardo Focus groups comprised of FQHC consumerso Representatives of other service organizations and/or local

advocacy groups

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o Relationship Models:o One organization refers its patients to the other organization

for services (referral arrangement)o One organization co-locates to the other organization’s facility

(co-location arrangement)o FQHC purchases services and/or capacity from the health

department (purchase of services arrangement)

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o Referral Arrangement Considerationso Under a referral arrangement, both the FQHC and

the health department typically continue to perform the same scope of services

o All services provided within an FQHC’s scope of project via referral to another provider must be provided through a formal referral arrangement

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o Under referral arrangement, the FQHC and the health department maintain their own employees and contractors

o Credentialing requirements, by-laws and clinical policies of the organization providing services govern

o FTCA coverage is available to the FQHC if it is the referral provider

o FTCA coverage is not available for the health department or its contracted or employed health care professionals

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o Co-Location Arrangementso Relationship under which a provider agrees to treat

patients who are referred to it by another providero Maintains its own practice and control over the

provision of the referral services and is legally and financially responsible for the referral services

o Health care professional furnishing the referral services is physically located at the other organization’s site

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o Co-Location Agreemento Patients are simply referred to the health department

as they would be under a standard referral relationship

o If FQHC establishes a site within the health department, the FQHC must obtain prior approval from HRSA to add the site to its scope of project

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o Lease of Space and/or Equipmento FQHC and health department should execute a

lease covering the space, equipment, utilities, supplies, and support personnel that will be utilized by the co-located provider, as well as other associated costs

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o Co-Location Agreement should contain assurances from the co-located provider regarding professional qualifications, licensure, certification, insurance, eligibility to participate in federal programs with regard to the other organization and its professionals

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o FTCA coverage is available if the FQHC co-locates to an health department facility, adds the site to its scope of project, and provides services within its scope of project

o Under the co-location arrangement, FTCA coverage is not available for the health department, its employees and its contracted health care professionals

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o Purchase of Services Arrangementso One organization purchases services from the other

organization, which provides such services as a vendor and on behalf of the other “purchasing” organization

o FQHCs and health departments may enter into arrangements for the purchase of administrative services

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o The purchasing organization is the provider of record for the contracted services rendered to patients

o Services provided by the vendor organization may be provided at either the purchasing organization’s facility or at the vendor organization’s facility

o FQHC and health department remain separate entities

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o Purchase of Services Agreemento If the service(s) provided to FQHC patients by the

contracted health department health care professional(s) are not within the FQHC’s scope of project, then the FQHC must request and obtain prior approval from HRSA to add the services

o FQHC must confirm that the location qualifies as a “site”

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o Reimbursement from Payors and Patientso Patients served under this arrangement would be considered

FQHC patients for all services provided and, the FQHC would bill appropriate third party payors and collect any fees from patients

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o Purchase of Services Agreement should include provisions to ensure that the health department health care professional provides services to the FQHC patients in the same manner as if the FQHC was providing the services directly

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o Agreement must be directly between the FQHC and the individual health professional providing services

o Agreement between the FQHC and health department will not extend FTCA coverage to the individual health professional who is an health department employee

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o Additional legal issues that should be addressed in structuring FQHC-health department partnerships:o Federal tax considerationso Federal fraud and abuse law (e.g., anti-kickback, false claims)o Federal physician self-referral law (Stark)o Federal Antitrust lawo HIPAA and 42 CFR Part 2o HHS Uniform Administrative Requirementso State counterparts to federal laws, including fraud, abuse, and self-referralo Clinic licensure and certificate of need lawso Professional licensure, certification and/or other authorization to render serviceso Zoning lawso Corporation/LLC statuteso Privacy of patient health informationo Insuranceo Scope of practice (including supervision requirements for non-physician providers

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Questions/Follow-up

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Gerald “Jud” E. DeLoss

Popovits & Robinson

[email protected]

(708) 479-3230

www.popovitslaw.com