A Local Health Department and Federally Qualified Health Center: The Public Entity Ninth Annual Rural Public Health Inst

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” E. DeLoss Popovits & Robinson jud@popovitslaw.com (708) 479-3230 Popovits & Robinson

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

3. 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

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

5. Federal Tort Claims Act • 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

6. 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

7. 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

8. 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

9. FTCA - Coverage • Coverage/Protection for Covered individuals • FTCA similar tooccurrence 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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

18. FTCA - Coverage • Continuity of care • 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

19. 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

20. 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

21. FTCA – Coverage in Emergencies 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

22. FTCA – Coverage in Emergencies • 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

23. 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

24. FTCA – Acceptance by Hospitals andManaged 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

25. 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

26. FTCA – Legal Claim Procedure Popovits & Robinson

27. 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

28. 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

29. 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

30. 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

31. 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

32. 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

33. 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

34. 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

35. 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

36. 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

37. 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

38. Risk Management Program • 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

39. Risk Management Program • 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

40. Risk Management Program • 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

41. Risk Management Program 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

42. 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

43. 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

44. 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

45. 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

46. 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

47. 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

48. 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

49. 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

50. 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