Ninth Annual Rural Public Health Institute

Ninth Annual Rural Public Health Institute
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 (708) Popovits & Robinson 1

Legal Issues Confronting the FQHC and Public Health Department
Popovits & Robinson 2 Popovits & Robinson 2

Federal Tort Claims Act
Under the Public Health Service Act, employees of eligible FQHCs may be deemed to be federal employees qualified for protection under the FTCA There is no cost to participating FQHCs or their providers, and they are not liable for any settlements or judgments 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

Deemed FQHC grantees are immune from medical malpractice lawsuits resulting from: Medical Surgical Dental Related functions Within the approved scope of project Popovits & Robinson 4

Eligible FQHCs must submit an original deeming and annual renewal deeming applications 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 These claims are reviewed and/or litigated by HHS Office of the General Counsel and DOJ Popovits & Robinson 5

FTCA - Eligibility FTCA Grantees eligible to be deemed are:
Community Health Centers (CHC) Migrant Health Centers (MHC) Health Care for the Homeless (HCH) Health Centers Public Housing Primary Care (PHPC) Health Centers Subrecipients eligible for FTCA coverage Popovits & Robinson 6

FTCA - Subrecipient What is a subrecipient?
Defined as an entity (not an individual contractor) that receives a grant or a contract from a deemed FQHC Provides the full range of health services on behalf of the deemed FQHC Only for those services under the scope of the project Contractual relationships with other entities for individual services (e.g., laboratory, pharmacy, physician services) are not subject to FTCA coverage Popovits & Robinson 7

FTCA - Coverage FTCA is only available for: FQHC
Full or part-time FQHC employees Individually contracted providers who furnish services in the fields of: General internal medicine Family practice General pediatrics OB/GYN Individually contracted providers who furnish services in other fields of practices on full-time basis A contract between a FQHC and a provider's corporation does not confer FTCA coverage on the provider Popovits & Robinson 8

FTCA - Coverage Coverage/Protection for Covered individuals
FTCA similar to occurrence insurance policy Do not need to purchase tail coverage Non-Covered Individuals Individuals who do not meet the statutory requirements for covered individuals Examples include: Volunteer physicians Part-time (less than 32.5 hours) contract dentists The FQHC remains covered, while the individual is not Popovits & Robinson 9

FTCA – Specific Situations
Indemnification of Other Entities FTCA coverage does not extend to indemnification or hold harmless of other entities Governing Board Members and Officers The governing board members and officers are covered under the FTCA only for medical malpractice Popovits & Robinson 10

FTCA - Coverage Covered Activities
FTCA coverage is restricted to scope of employment 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 The FQHC is responsible to maintain current records Popovits & Robinson 11

FTCA - Coverage Scope of Employment
Includes performance under a contract All covered individuals should have current, written job descriptions FTCA matters may come to litigation, so job descriptions play a key role in demonstrating scope of employment and FTCA coverage Moonlighting is not within the scope of project Popovits & Robinson 12

FTCA - Coverage Scope of Project
FTCA coverage is limited to the performance of medical, surgical, dental, or related functions New services and sites are dependent on approval of a change in the scope of the project A request for a change in scope should be submitted to HRSA/BPHC for approval Popovits & Robinson 13

FTCA - Coverage Services to FQHC Patients
A patient-provider relationship must be established For purposes of FTCA coverage, the patient-provider relationship is established when: Individuals access care for initial or follow-up visits at approved sites Individuals access care at approved sites even if not permanent residents Triage services are provided by telephone or in person, even if patient is not yet registered but is intended to be registered Popovits & Robinson 14

FTCA – Coverage FTCA coverage for services to non-FQHC patients is available in certain situations Examples of Covered Services to Non-FQHC Patients: Community-Wide Intervention School-Based Clinics School-Linked Clinics Health Fairs Popovits & Robinson 15

FTCA – Particularized Determination
Other examples of Covered Services to Non-FQHC Patients: Immunization Campaigns Migrant Camp Outreach Homeless Outreach Hospital-Related Activities Coverage-Related Activities Popovits & Robinson 16

FTCA – Particularized Determination
Acts and omissions related to services for non-FQHC patients may be covered if approved particularized determination of FTCA coverage The application for a particularized determination must provide: Services to non-FQHC patients will benefit FQHC patients and general populations Services to non-FQHC patients facilitates the provision of services to FQHC patients Such services are otherwise contractually-required Request for a particularized determination of FTCA coverage must include sufficient detail Popovits & Robinson 17

FTCA - Coverage Continuity of care Supervision of non-FQHC staff
Covered individual may follow FQHC patient to non-FQHC site to maintain continuity of care Supervision of non-FQHC staff Supervision of Students and Medical Residents Activities under other grant funding Clinical research Assisting with community events Popovits & Robinson 18

FTCA – Coverage Under Alternate Billing
FQHC providers may bill directly for services provided to FQHC facility patients 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 Popovits & Robinson 19

FTCA – Coverage in Emergencies
Emergency situations FTCA coverage will apply to the performance of medical, surgical, dental, or related functions at temporary locations If covered individuals volunteer in their individual capacity to respond to an emergency, they will not be protected under FTCA Patients served by covered individuals at temporary locations are considered the FQHC’s patients Popovits & Robinson 20

In rare cases emergency may impact an entire region or State 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 If covered individuals volunteer in their individual capacity to respond to an emergency they will not be protected under FTCA Popovits & Robinson 21

In emergency situations, FQHCs that are not directly impacted by the emergency may: Assist at temporary sites within the FQHC’s own service area and within neighboring counties, parishes, or political subdivisions 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 Popovits & Robinson 22

FTCA – Public Health Department
FTCA coverage is available only to the FQHC and individuals identified above Cannot be extended to the Health Department or its employees Unless they are individually contracted to the FQHC Satisfy the above-mentioned criteria for individual coverage Popovits & Robinson 23

FTCA – Acceptance by Hospitals and Managed Care Plans
Covered individual cannot be denied hospital privileges solely because malpractice protection is FTCA Managed care plans, including HMOs and similar entities, must accept FTCA coverage as meeting malpractice insurance coverage requirements Hospitals or managed care plans that fail to comply in jeopardy of losing ability to collect payment under Medicare and Medicaid Popovits & Robinson 24

FTCA - Insurance FQHC has option to meet malpractice liability through FTCA or private insurance FQHCs not applied for, or have terminated FTCA, may use Federal grant funds for private malpractice insurance Dual coverage (i.e., both FTCA and private malpractice insurance covering the same activities) is not permitted US Government may subrogate claims where FQHC has private coverage and payment is made under FTCA Gap Coverage non-covered activities or non-covered individuals Even with FTCA coverage, FQHCs will continue to need other types of insurance: Non-medical/dental professional liability coverage General liability coverage D & O coverage Automobile and collision Fire and theft coverage FQHC applying for initial FTCA deeming, should have private malpractice insurance in place until deemed Popovits & Robinson 25

FTCA – Legal Claim Procedure
Popovits & Robinson 26

FTCA – Legal Claim Procedure
Statute of Limitations Claim must be presented within two years after the claim accrues Generally, accrual occurs on the date of the injury However, also incorporates a discovery rule State statute of limitations periods do not apply to claims filed under the FTCA. Popovits & Robinson 27

FTCA - Deeming To be deemed, a grantee or subrecipient must complete an application that demonstrates that it: Risk management policies and procedures Credentialing and privileging system Has no history of claims or, if such a history exists, has fully cooperated with DOJ Cooperate to provide information related to a claim Popovits & Robinson 28

FTCA – Deeming Process Tips
Deeming applicants must: Submit FTCA application materials in a timely manner Respond in a timely manner to all requests from HRSA Demonstrate implementation of the required policies Accurately present all material facts HRSA’s goal to support all FQHCs in successfully demonstrating compliance with and implementation of these requirements Popovits & Robinson 29

FTCA – Deeming Process Tips
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 HRSA will conduct its review within 30 days 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 Should the requested information not be submitted within 10 business days of notification, the applicant will be required to submit a new application Popovits & Robinson 30

FTCA – Additional Requirements
Health Center policies and procedures for the following must be included: Referral tracking Hospitalization tracking Diagnostic tracking Statement verifying that any professional liability claims were internally analyzed Statement should include the following for each claim filed within the last five years: Name of provider(s) involved Area of practice/Specialty Date of occurrence Summary of allegations Status and outcome of claim Popovits & Robinson 31

FTCA – Additional Requirements
Electronic Signature of the Executive Director Deeming Applications for any subrecipient(s) Considered part of the deeming application of the grantee 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 Popovits & Robinson 32

FTCA – Annual Renewal All currently deemed grantees must submit a FTCA renewal application for themselves and any subrecipients 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 Popovits & Robinson 33

FTCA – Site Visits HRSA may elect to conduct a site visit at any point during the application review process and/or as part of its oversight responsibilities Factors that may prompt a site visit include, but are not limited to: Submission of an initial FTCA deeming application Unresolved questions identified during the review of the FQHC’s application Need for follow-up based on prior site visit findings or other identified issues History of repeated pertinent conditions History of claims Popovits & Robinson 34

FTCA – Site Visits Site visit reviewers will assess whether applicant:
Risk management policies and procedures Credentialed and privileged its physicians and other licensed or certified health care practitioners 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 Popovits & Robinson 35

FTCA - Risk Management 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 Popovits & Robinson 36

Risk Management Program
Risk management program is critical: Promote safe and effective patient care practices Maintain a safe working environment Protect FQHC’s financial resources Popovits & Robinson 37

Effective program can: Identify and mitigate liability exposures Prevent and reduce the severity of adverse events Improve patient experience Increase provider and staff satisfaction Popovits & Robinson 38

Value to FQHC: Secure commitment to improve Review injuries, adverse events, and near misses to prevent re-occurrence Promote system improvement Reduce liability exposure Encourage open communication among providers and staff Establish a culture of safety Popovits & Robinson 39

Key principles of the program include: Claims management Complaint resolution Confidentiality and release of patient information Event investigation, root-cause analysis, and follow-up Failure mode and effects analysis Provider and staff education, competency validation, and credentialing requirements Reporting and management of adverse events and near misses Trend analysis of events, near misses, and claims Popovits & Robinson 40

Risk management program should be administered through the Risk Manager who reports to the administrator/CEO Risk Manager should interact with administration, staff, medical providers, and other professionals Risk Manager should chair the Risk Management Committee Popovits & Robinson 41

FTCA – Credentialing and Privileging
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 ….” Popovits & Robinson 42

FTCA – Credentialing Details
Credentialing of Licensed Independent Practitioners (LIPs) requires primary source verification of: Current licensure Relevant education, training, or experience Current competence Health fitness, or the ability to perform the requested privileges Credentialing of LIPs requires secondary source verification of: Government issued ID DEA registration Hospital privileges Immunization and PPD status Life support training Query of the National Practitioner Data Bank (NPDB) Determination that LIP meets credentialing requirements by FQHC’s governing board Popovits & Robinson 43

FTCA – Credentialing Details
Credentialing of other health care practitioners requires primary source verification of: License, registration, or certification Education and training may be verified by secondary source verification Verification of current competence through review of clinical qualifications and performance Credentialing of other health care practitioners requires secondary source verification of the following: Government issued ID Immunization and PPD status DEA registration Hospital admitting privileges Life support training Popovits & Robinson 44

FTCA – Credentialing and Privileging
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 Credentialing list must include the following: Name and Professional Designation (e.g., MD/DO, RN, CNM, DDS, LPN, PA, MA, NP, etc.) Title/Position Specialty Employment Status (full-time employee, part-time employee, contractor or volunteer) Hire Date Current Credentialing Date (must be within past two years) Next Expected Credentialing Date (if known) Popovits & Robinson 45

FTCA - Privileging Revision or renewal of a privileges at least every 2 years Include synopsis of peer review results for the 2 year period and/or any relevant performance improvement information Approval of subsequent privileges vested in the board The FQHC should have an appeal process LIPs Appeal process is optional for other licensed or certified health care practitioners. NOTE: FTCA requirements may not be the same as accreditation-related standards FQHCs that are accredited or seeking accreditation should also review the applicable accreditation body standards Popovits & Robinson 46

Credentialing & Privileging - Board
FQHC’s credentialing and privileging policies and procedures must include documentation of Board approval Credentialing and privileging policies and procedures must be approved, signed and dated by the Board Popovits & Robinson 47

FTCA - Quality Improvement/Quality Assurance
Initial or renewal application must contain Quality Improvement/Quality Assurance (QI/QA) Plan Clear documentation that the Board reviewed and approved the plan within three (3) years of the date of submission QI/QA plan must be approved, dated, and contain the appropriate signature(s) of the Board of Directors Popovits & Robinson 48

FTCA - Quality Improvement/Quality Assurance
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 Popovits & Robinson 49

Quality Improvement/Quality Assurance
FQHC has an ongoing Quality Improvement/Quality Assurance (QI/QA) which must include: Clinical director Periodic assessment of the appropriateness of the utilization of services and the quality of services provided Conducted by physicians or by other licensed health professionals under the supervision of physicians Based on the systematic collection and evaluation of patient records Identify and document the necessity for change in the provision of services by the FQHC Popovits & Robinson 50

Quality Improvement/Quality Assurance
The clinical director must have clear responsibility for conducting QI/QA assessments/activities 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 Plan must measure and evaluate patient satisfaction The FQHC must have clinical information systems in place for key performance data The findings of the QI/QA process are used to improve organizational performance Popovits & Robinson 51

State Tort Immunity Illinois provides limited immunity from tort lawsuits Local Governmental and Governmental Employees Tort Immunity Act Provides for coverage for medical facilities, public health clinic, and physicians Coverage available for certain injuries and claims 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 Popovits & Robinson 52

State Tort Immunity Many public and local hospitals and medical centers are protected from medical malpractice claims by the Act Generally, failure to diagnose or treat a patient at a public health facility is immunized by the Act However, public medical personnel and entities are not immune from: Negligently or wrongfully prescribing treatment Negligence, wrongful act, or omission in administering the prescribed treatment The Act may not immunize actions or omissions by “independent contractors”, who are not deemed “employees” Popovits & Robinson 53

Governance Organizations must have a governing body which assumes full authority and oversight responsibility for the FQHC The governing board must maintain an acceptable size, composition, and meeting schedule 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 Popovits & Robinson 54

Governance FQHC must have governing body which:
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 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 Popovits & Robinson 55

Governance – Public Entities
Public entities operating FQHC programs may meet the governance requirement in either of two ways The public entity's board may meet FQHC board composition requirements including having a consumer majority When the public entity's board does not meet FQHC composition requirements, a separate FQHC governing board may be established FQHC board can be a formally incorporated entity and it and the public entity board are co-applicants for the FQHC program 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. Upon showing of good cause the Secretary may waive all or part of the requirements Popovits & Robinson 56

Governance Public centers with co-applicant boards must meet all the membership requirements and perform all the responsibilities expected of governing boards Except co-applicant board is permitted to retain authority for establishing general policies (fiscal and personnel policies) Popovits & Robinson 57

Governance FQHC’s board: Meets monthly
FQHCs with approved waivers ONLY may have appropriate strategies in place to ensure regular oversight, if the board does not meet monthly Reviews and approves the annual FQHC (renewal) application and budget Conducts an annual review of the CEO’s performance Popovits & Robinson 58

Governance FQHC’s board:
Reviews and approves the services to be provided and the FQHC’s hours of operation Measures and evaluates the FQHC’s progress in meeting annual and long term clinical and financial goals Engages in strategic and/or long term planning for the FQHC Popovits & Robinson 59

Governance FQHC’s board:
Reviews mission and bylaws on a periodic basis Receives appropriate information that enables it to evaluate FQHC patient satisfaction, organizational assets, and performance Establishes the general policies, including: Personnel Health care Fiscal and quality assurance/improvement With the exception of fiscal and personnel policies in the case of a public agency grantee in a co-applicant arrangement Popovits & Robinson 60

Governance - Public Health Department
For Public Center Grantees with Co-Applicant Arrangements only—Public center grantee has a formal co-applicant agreement: Roles, responsibilities, and the delegation of authorities Any shared/split responsibilities between the public center and co-applicant board Popovits & Robinson 61

Governance 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 Governing board has at least 9 but no more than 25 members The remaining non-consumer members of the board shall be representative of the community 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 Popovits & Robinson 62

Governance A majority (at least 51%) of the board members receive services (i.e., are patients) at the FQHC There is no established ratio for board members to population served; however, board composition must be reasonably representative of the populations being served FQHCs with approved waivers only–appropriate strategies are in place to ensure consumer/patient participation and input from the target population Popovits & Robinson 63

Governance 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 No board member shall be an employee of the FQHC or an immediate family member of an employee CEO may serve only as a non-voting ex-officio member of the board Popovits & Robinson 64

Governance The FQHC’s conflict of interest policy must address:
Disclosure of business and personal relationships, including nepotism Extent to which a board member can participate in board decisions where the member has a personal or financial interest Using board members to provide services to the center Expense reimbursement policies Acceptance of gifts and gratuities Personal political activities of board members Consequences for violating the conflict policy Written standards of conduct governing the performance of its employees engaged in the award and administration of contracts Popovits & Robinson 65

Governance Options to assist the FQHC in its assessment of health service needs of special populations: Inclusion on the board of persons who previously have been FQHC consumers, but no longer receive services Use of an advisory board Focus groups comprised of FQHC consumers Representatives of other service organizations and/or local advocacy groups Popovits & Robinson 66

Relationship Between FQHC and Public Health Department
Relationship Models: One organization refers its patients to the other organization for services (referral arrangement) One organization co-locates to the other organization’s facility (co-location arrangement) FQHC purchases services and/or capacity from the health department (purchase of services arrangement) Popovits & Robinson 67

Referral Arrangement Considerations Under a referral arrangement, both the FQHC and the health department typically continue to perform the same scope of services All services provided within an FQHC’s scope of project via referral to another provider must be provided through a formal referral arrangement Popovits & Robinson 68

Under referral arrangement, the FQHC and the health department maintain their own employees and contractors Credentialing requirements, by-laws and clinical policies of the organization providing services govern FTCA coverage is available to the FQHC if it is the referral provider FTCA coverage is not available for the health department or its contracted or employed health care professionals Popovits & Robinson 69

Co-Location Arrangements Relationship under which a provider agrees to treat patients who are referred to it by another provider Maintains its own practice and control over the provision of the referral services and is legally and financially responsible for the referral services Health care professional furnishing the referral services is physically located at the other organization’s site Popovits & Robinson 70

Co-Location Agreement Patients are simply referred to the health department as they would be under a standard referral relationship 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 Popovits & Robinson 71

Lease of Space and/or Equipment 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 Popovits & Robinson 72

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 Popovits & Robinson 73

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 Under the co-location arrangement, FTCA coverage is not available for the health department, its employees and its contracted health care professionals Popovits & Robinson 74

Purchase of Services Arrangements One organization purchases services from the other organization, which provides such services as a vendor and on behalf of the other “purchasing” organization FQHCs and health departments may enter into arrangements for the purchase of administrative services Popovits & Robinson 75

The purchasing organization is the provider of record for the contracted services rendered to patients Services provided by the vendor organization may be provided at either the purchasing organization’s facility or at the vendor organization’s facility FQHC and health department remain separate entities Popovits & Robinson 76

Purchase of Services Agreement 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 FQHC must confirm that the location qualifies as a “site” Popovits & Robinson 77

Reimbursement from Payors and Patients 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 Popovits & Robinson 78

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 Popovits & Robinson 79

Agreement must be directly between the FQHC and the individual health professional providing services Agreement between the FQHC and health department will not extend FTCA coverage to the individual health professional who is an health department employee Popovits & Robinson 80

Additional legal issues that should be addressed in structuring FQHC-health department partnerships: Federal tax considerations Federal fraud and abuse law (e.g., anti-kickback, false claims) Federal physician self-referral law (Stark) Federal Antitrust law HIPAA and 42 CFR Part 2 HHS Uniform Administrative Requirements State counterparts to federal laws, including fraud, abuse, and self-referral Clinic licensure and certificate of need laws Professional licensure, certification and/or other authorization to render services Zoning laws Corporation/LLC statutes Privacy of patient health information Insurance Scope of practice (including supervision requirements for non-physician providers Popovits & Robinson 81

Questions/Follow-up Gerald “Jud” E. DeLoss Popovits & Robinson (708) Popovits & Robinson 82

Ninth Annual Rural Public Health Institute

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