FEDERAL TORT CLAIMS ACT FTCA COVERAGE FOR HEALTH

FEDERAL TORT CLAIMS ACT (FTCA) COVERAGE FOR HEALTH CENTERS Lexington, Kentucky March 8, 2017 Martin J. Bree © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com

FTCA Part 1 May 8, 2017 8: 30 AM – 9: 30 AM © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 2

DISCLAIMER This training has been prepared by the attorneys of Feldesman Tucker Leifer Fidell LLP. The materials are being issued with the understanding that in conducting this training program the authors are not engaged in rendering legal services. If legal assistance is required, the services of a competent attorney should be sought. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 3

MARTIN J. BREE • Marty’s practice involves general health law matters with a focus on professional liability and FTCA problems as well as other grant related compliance issues. • Marty was a Commissioned Officer of the U. S. Public Health Service from 1976 to 2004. He started his career in Philadelphia as a project officer working with Health Centers and the National Health Service Corps. During his career he held various positions in the HRSA’s Philadelphia, New York, Chicago and Kansas City Regional Offices. From 1998 through 2004 he directed the Health Center FTCA medical malpractice protection program. • From 2004 to 2010, Marty was the Senior Partner in the Triton Group, LLC providing technical assistance to Health Centers, HRSA, and other federal and state agencies on medical malpractice, risk management and the FTCA program. • MBree@FTLF. com • (202) 466 -8960 © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 4

The Federal Tort Claims Act © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 5

FEDERAL TORT CLAIMS ACT • • Signed into law on June 25, 1946. Waived the sovereign immunity of the United States allowing individuals to sue the United States for negligence of government officers and employees. This waiver is limited. The government maintains its sovereign immunity for a variety of offenses committed by its employees, e. g. , intentional torts, discretionary functions. Plaintiffs must follow specific statutory rules to be successful in seeking monetary damages. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 6

The Federally Supported Health Centers Assistance Act © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 7

FEDERALLY SUPPORTED HEALTH CENTERS ASSISTANCE ACT - IMMUNITY But before you can understand where you are, you have to understand where you’ve been…. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 8

A BRIEF HISTORY… BEFORE FSHCAA ‘ 80 s & ‘ 90 s: Malpractice crisis for health centers: • Malpractice costs were large proportion of budgets. • Evidence of low rates of claims against health centers. • Only 10% of premiums were paid out in claims (H. R. Report 823). Model Solution: 1988 Indian Self-Determination and Education Assistance Act. Provided immunity to health care contractors under certain grants from Indian Health Service or Department of Interior. Patients remedy was claim against the United States under FTCA. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 9

A BRIEF HISTORY… 1992 LEGISLATION • In 1992 Congress passes the Federally Supported Health Centers Assistance Act of 1992. • Makes health centers and certain staff Public Health Service employees. • Grants immunity from suit for professional services (medical, surgical, dental and related activity. ) • Patient only remedy a claim under the FTCA. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 10

A BRIEF HISTORY… 1992 LEGISLATION Problems with the FSHCAA of 1992 • No advance coverage/after the fact coverage determination created uncertainty • Hospitals didn’t want to grant privileges to health center provider • Coverage of non-health center patients not certain • Expiration of the law in 1995 made buy-in difficult Regulations released in 1995 attempted to remedy these problems. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 11

A BRIEF HISTORY… 1995 REGULATIONS May 1995 Rule: The rule published in 45 CFR Part 6 that “set forth information whereby an entity or a person can determine when, and the extent to which, it is likely to be protected” by the FTCA program. September 1995 Rule: Clarified the May 1995 rule adding a process to secure FTCA program coverage for care to non-health center patients, as well as examples of pre-approved care to non-health center patients. **THESE REGULATIONS PREDATE 1995 AMENDMENTS TO FSCHAA of 1992 © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 12

A BRIEF HISTORY… 1995 LEGISLATION Federally Supported Health Centers Assistance Act (FSHCAA) of 1995: • Signed into law December 26, 1995 • Clarified the 1992 Act (in some respects) • Eliminated the 1992 Act’s sunset provision, making the program permanent • Incorporated some of the prior regulations into law. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 13

1995 -PRESENT (PINS & PALS) Health Resources & Services Administration (HRSA) publishes Policy Information Notices (PINs) 93 -07, 9319, and 96 -7 that provide policy information on the FTCA program. PIN 99 -08: The first comprehensive statement of HRSA’s policy regarding the FTCA program. – Repeals earlier PINs; – Explains scope of coverage; – Sets forth the now familiar application process; and – Does not define a “health center patient. ” © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 14

1995 -PRESENT (PINS & PALS) PIN 2001 -16 (July 2001) – Establishes guidance on credentialing and privileging for health center practitioners. PIN 2001 -19 (September 2001) – Establishes the application of the Touhy rule to deemed health centers and individuals. PIN 2002 -22 (July 2002) – Lays out specific requirements for credentialing and privileging of clinical staff in all Bureau of Primary Health Care (BPHC) funded activities. PIN 2007 -16 (August of 2007) – Establishes policy for FTCA coverage in times of local, state or national disasters. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 15

1995 -2016 (PINS & PALS) PIN 2011 -01, the FTCA Manual is published on January 3, 2011. – “the primary source for information on FTCA for health center program grantees…”(PIN 2011 -01). – BUT “if there any conflicts between its content and FTCA law as interpreted by the courts (including federal statutes, regulations, and case law), the law prevails” (PIN 2011 -01). Updated and Reissued on July 21, 2014 as the “Federal Tort Claims Act Health Center Policy Manual” © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 16

1995 -PRESENT (2013: A NEW REGULATION) • FSHCAA and 42 CFR section 6. 6(d) authorize FTCA coverage for services to non-health center patients in certain situations. • FTCA Program regulatory amendments published on September 23, 2013, (78 Federal Register 58202) incorporate, clarify, and add to the situations identified in the September 1995 Notice. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 17

A BRIEF LEGAL PRIMER How do FSHCAA, the regulations, the PINs and PALs, and the FTCA Policy Manual interact with each other? © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 18

A BRIEF LEGAL PRIMER U. S. Constitution 42 U. S. C. § 233 “Immunity” y Federall ed Support enter Health C Act ce Assistan Statutes Part 6 R F C 2 4 ons for i s s i m and O s t c A d nters e C Covere h t l Hea ) 14 -02 0 2 # al (PIN u n a rage M e v y o c i l C Po FTCA 6 -03) r FTCA o f s ment # 201 e L r i A u P ( q Re enters C 2017 h t l a for He Regulations Guidance © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 19

CONTINUUM OF “COVERAGE” HRSA Policy Guidance, regulations & law support action taken by health center Regulations &/or law support action taken by health center No clarity in the regulations or law © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 20

FEDERALLY SUPPORTED HEALTH CENTERS ASSISTANCE ACT - IMMUNITY What is immunity? Section 233(a) - The remedy against the United States provided by Sections 1346(b) and 2672 of Title 28, or by alternative benefits provided by the United States where the availability of such benefits precludes a remedy under Section 1346(b) of Title 28, for damage for personal injury, including death, resulting from the performance of medical, surgical, dental, or related functions, including the conduct of clinical studies or investigation, by any commissioned officer or employee of the Public Health Service while acting within the scope of his office or employment, shall be exclusive of any other civil action or proceeding by reason of the same subject-matter against the officer or employee (or his estate) whose act or omission gave rise to the claim. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 21

FEDERALLY SUPPORTED HEALTH CENTERS ASSISTANCE ACT - IMMUNITY Key Components of Immunity: • Damages action for personal injury or death • Resulting from the performance of medical, surgical, dental, or related functions • Acts or omissions within the scope of employment © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 22

FEDERALLY SUPPORTED HEALTH CENTERS ASSISTANCE ACT - IMMUNITY What’s NOT in FSHCAA: • Any language regarding: • Sites • Services • Scope of Project • Form 5 A, B, C © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 23

FEDERALLY SUPPORTED HEALTH CENTERS ASSISTANCE ACT - IMMUNITY Reasons why the FTCA Program fails to achieve its objective (in many ways): • Disconnect between the concepts of waiver and immunity • The Program is implemented by policy/guidance “requirements” (an oxymoron) © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 24

FEDERALLY SUPPORTED HEALTH CENTERS ASSISTANCE ACT - IMMUNITY © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 25

FEDERALLY SUPPORTED HEALTH CENTERS ASSISTANCE ACT - IMMUNITY © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 26

FTCA PART 2 May 8, 2017 9: 45 AM – 10: 45 AM © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 27

FEDERALLY SUPPORTED HEALTH CENTERS ASSISTANCE ACT - IMMUNITY • Who has immunity? – Deemed health centers; – Board members, officers, directors; – All employees, full-time or part-time; – Full time contract providers (at least 32. 5 hours per week for the period of the contract); and – Part time contract provider of services in the fields of family practice, ob-gyn, general internal medicine, or general pediatrics. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 28

FEDERALLY SUPPORTED HEALTH CENTERS ASSISTANCE ACT - IMMUNITY • Contractors – 42 U. S. C. § 233(g)(1)(A) “…any contractor of such an entity who is a physician, or other licensed or certified health care practitioner. ” – 42 U. S. C. § 233 (g)(5) “an individual may be considered a contractor. ” © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 29

FEDERALLY SUPPORTED HEALTH CENTERS ASSISTANCE ACT - IMMUNITY Scope of Employment • Determined by state law. • Must be acting on behalf of the deemed entity. • Documentation of scope of employment should be “of sufficient detail to provide clarity in determining if the individual in question was acting within the scope of his employment. ” and therefore “covered under FSHCAA and the FTCA”. (FTCA Policy Manual) © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 30

FEDERALLY SUPPORTED HEALTH CENTERS ASSISTANCE ACT - IMMUNITY • Per HRSA Policy, Immunity may also limited to actions within the Scope of Project. • Activities must be “within the approved scope of the project, including sites, services, and other activities and locations as defined in PIN 2008 -01: Defining Scope of Project and Policy for Requesting Changes (relevant forms are 5 -A, 5 -B, and 5 -C)” – PIN 2011 -01. • But, “Only acts or omissions related to the grantsupported activity of entities are covered” – 42 CFR Part 6 § 6. 6(d) published May 8, 1995). • The activity must occur during the provision of services to the covered entity’s patients and, in certain circumstances, to non-health center patients. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 31

FEDERALLY SUPPORTED HEALTH CENTERS ASSISTANCE ACT - IMMUNITY “Scope of Project” • Activities listed in Forms 5 A, 5 B and 5 C. • PIN 2008 -01, “Defining Scope of Project & Policy for Requesting Changes”. • FTCA coverage for new services and sites is dependent on HRSA/BPHC approval of a change in scope. • A request for a change in scope must be submitted separate from grant application. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 32

FEDERALLY SUPPORTED HEALTH CENTERS ASSISTANCE ACT - IMMUNITY 42 U. S. C. 233 Statute “scope of employment" 42 CFR Part 6 Regulations “grant supported activity” Policy Manual “scope of project” © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 33

FEDERALLY SUPPORTED HEALTH CENTERS ASSISTANCE ACT - IMMUNITY • Services • Only services listed in Form 5 A in EHB are covered. • It is not necessary to specify procedures on Form 5 A. • To add or delete a service, a health center must go through the “Change in Scope” process. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 34

FEDERALLY SUPPORTED HEALTH CENTERS ASSISTANCE ACT - IMMUNITY • Sites • With a few exceptions only the provision of services at sites within the scope of project (Form 5 B) are covered. • Exceptions (from PIN 2011 -01). • Form 5 C, Intermittent sites (PIN 2008 -01). • Only care delivered to existing health center patients at Form 5 C sites is covered (with exceptions). © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 35

FEDERALLY SUPPORTED HEALTH CENTERS ASSISTANCE ACT - IMMUNITY • • Who is a “Health Center Patient”? Turns on the establishment of a patient/provider relationship which occurs when (per FTCA Policy Manual): – Individuals access care for initial or follow-up visits at approved sites that are owned or operated by the covered entity; – Individuals access care at approved sites even if they are not permanent residents of the service area or may only be receiving care temporarily; or – Health center triage services are provided by telephone or in person, even when the patient is not yet registered with the covered entity but is intended to be registered. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 36

FEDERALLY SUPPORTED HEALTH CENTERS ASSISTANCE ACT - IMMUNITY • • No immunity for care to non-health center patients. Except: – Secretary of HHS has pre-approved certain situations where care is delivered to non-health center patients. – These examples must be strictly interpreted. Health centers must be “painstakingly exact” to make certain that what they do “fits squarely” within the examples. – Examples are found in September 23, 2013 Federal Register Notice. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 37

FEDERALLY SUPPORTED HEALTH CENTERS ASSISTANCE ACT - IMMUNITY • Examples of care to non-health center patients that the Secretary has approved: School-based clinics School-linked clinics Health fairs Immunization campaigns Migrant camp outreach Homeless outreach Periodic hospital call or emergency room coverage • Cross-coverage activities • Individual emergencies • • © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 38

FEDERALLY SUPPORTED HEALTH CENTERS ASSISTANCE ACT - IMMUNITY • “Covered” Services to Non-Health Center Patients – School-Based Clinics: Health Center staff provide primary and preventive health care services at a facility located in a school or on school grounds. The Health Center has a written affiliation agreement with the school. – School-Linked Clinics: Health Center staff provide primary and preventive health care services, at a site not located on school grounds, to students of one or more schools. The Health Center has a written affiliation agreement with each school. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 39

FEDERALLY SUPPORTED HEALTH CENTERS ASSISTANCE ACT - IMMUNITY • “Covered” Services to Non-Health Center Patients – Health Fairs: On behalf of the health center, health center staff conduct or participate in an event to attract community members for purposes of performing health assessments. Such events may be held in the health center, outside on its grounds, or elsewhere in the community. – Immunization Campaign: On behalf of the health center, health center staff conduct or participate in an event to immunize individuals against infectious illnesses. The event may be held at the Health Center, schools, or elsewhere in the community. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 40

FEDERALLY SUPPORTED HEALTH CENTERS ASSISTANCE ACT - IMMUNITY • “Covered” Services to Non-Health Center Patients – Migrant Camp Outreach: Health Center staff travel to a migrant farmworker residence camp to conduct intake screening to determine those in need of clinic services (which may mean health care is provided at the time of such intake activity or during subsequent clinic staff visits to the camp). – Homeless Outreach: Health Center staff travel to a shelter for homeless persons, or a street location where homeless persons congregate, to conduct intake screening to determine those in need of clinic services (which may mean health care is provided at the time of such intake activity or during subsequent clinic staff visits to that location). © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 41

FEDERALLY SUPPORTED HEALTH CENTERS ASSISTANCE ACT - IMMUNITY • “Covered” Services to Non-Health Center Patients – Hospital Related Activities: Periodic hospital call or hospital emergency room coverage, as required by the hospital as a condition for obtaining hospital admitting privileges. There must also be documentation for the particular health care provider that this coverage is a condition of employment at the Health Center. – Coverage Related Activities: As part of a Health Center’s arrangement with local community providers for after-hours coverage of its patients, the Health Center’s providers are required by their employment contract to provide periodic or occasional cross-coverage for patients of these providers. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 42

FEDERALLY SUPPORTED HEALTH CENTERS ASSISTANCE ACT - IMMUNITY • “Covered” Services to Non-Health Center Patients – Coverage in Certain Individual Emergencies: A health center provider is providing or undertaking to provide covered services to a health center patient within the approved scope of project of the center, or to an individual who is not a patient of the health center under the conditions set forth in this rule, when the provider is then asked, called upon, or undertakes, at or near that location and as the result of a non-health center patient’s emergency situation, to temporarily treat or assist in treating that non-health center patient. In addition to any other documentation required for the original services, the health center must have documentation (such as employee manual provisions, health center bylaws, or an employee contract) that the provision of individual emergency treatment, when the practitioner is already providing or undertaking to provide covered services, is a condition of employment at the health center. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 43

FEDERALLY SUPPORTED HEALTH CENTERS ASSISTANCE ACT - IMMUNITY No immunity: • • • Volunteers (unless specifically applied for under 233(q). Good Samaritan Coverage. Providers billing directly (for exceptions, see FTCA Policy Manual)? Part-time contract providers not in primary care specialties. Health professional students. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 44

FEDERALLY SUPPORTED HEALTH CENTERS ASSISTANCE ACT - IMMUNITY No Immunity: • Contracts between a deemed health center and a corporation (including PCs). • Sub-grantees (unless an application has been submitted for them by the grantee). • Third parties seeking indemnification. • Providers acting outside the health center federal scope of project. • Providers acting outside their scope of employment. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 45

FEDERALLY SUPPORTED HEALTH CENTERS ASSISTANCE ACT - IMMUNITY No Immunity: • • Prior Acts – incidents occurring before initial deeming or hiring. Moonlighting (scope of employment). Intentional torts? Criminal activities. General Liability (e. g. , motor vehicle accidents, slip and fall). Failure to have written employment agreements? Contracts with hospitals and other providers of services. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 46

FEDERAL TORT CLAIMS ACT PROGRAM Deeming of Volunteers in Community Health Centers © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 47

VOLUNTEERS 21 st Century Cures Act provides for protection for volunteers in health centers (42 U. S. C. 233(q)). • Volunteer must be a health care practitioner at a deemed entity. • Must provides services at health center sites or offsite events carried out by entity. • The health center “sponsors” the volunteer by submitting an application to HHS for the volunteer. • The volunteer does not receive any compensation (other than reasonable expenses). • The health center posts a “clear and conspicuous” notice of the volunteers limitations of liability. • Volunteer is licensed or certified per Federal and State laws. • Health Center maintains relevant documentation certifying volunteer meets all requirements. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 48

VOLUNTEERS Unanswered Questions: • What form will application take? - Part of the existing deeming application, or Separate application(s). • What constitutes a “clear and conspicuous” notice? • Do “offsite events” include in-patient care? • When can applications be submitted, annually or when a volunteer comes on board? • Can requirements to be deemed be challenged by DOJ or plaintiff after Secretary’s deeming decision? © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 49

FTCA PART 3 May 8, 2017 11: 00 AM – 12: 00 PM © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 50

The FTCA Deeming Application: How To Obtain Immunity © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 51

2017 REVIEW PROCESS • Completeness and Accuracy (CA) Review: is the application complete? • FTCA Review: A review of the substance of the application. • Program Quality Check (PQC) Review: Insure consistency in decisions. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 52

2017 DEEMING APPLICATION • PAL 2016 -03 Calendar Year 2017 Requirements for Federal Tort Claims Act (FTCA) Coverage for Health Centers • Re-deeming applications were due May 24, 2016, EHB opened to receive applications on April 22, 2016. • Deeming applications are discoverable in an FTCA case. • CY 2018 application instructions delayed “a few weeks”. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 53

2017 DEEMING APPLICATION • Initial deeming applications may be submitted at any time during the year that EHB is open. • HRSA expects new deeming applicants to be operational for six months prior to submission. • For CY 2018, deeming application will be streamlined. Expect a “ 30%” reduction in documents submitted in application. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 54

2017 DEEMING APPLICATION REQUIREMENTS Referral tracking, hospitalization tracking and diagnostic tracking policies are now required to be board approved or approval may be delegated by the board. • Triage, walk-in, telephone triage and no-show appointment policies are also required to be Board approved or approval may be delegated by the board. • Clinical protocols that define appropriate treatment and diagnostic procedures for selected medical conditions are required to be Board approved or approval may be delegated by the board. • © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 55

REFERRAL TRACKING • Track all referrals from their origin until they are returned and evaluated by a provider. • Health center follows up with referral provider in a timely manner to ensure that information is received back from the referral provider. • Clearly identify titles of health center staff who are responsible for each of the duties throughout the referral tracking process. • Make documented efforts to follow up with patients who miss referral appointments. • The policy has been signed and approved by the Governing Board or the board has delegated its approval authority. Policy should state the delegation authority. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 56

DIAGNOSTIC TRACKING • A tracking and monitoring system is maintained for all diagnostic orders. • Agreements with labs that define “critical values” and process for contacting health center providers. • Procedures for contacting patients with critical lab values. • Responsibility is assigned for documentation of all pertinent diagnostic tracking activities. • Policy has been signed and approved by the Governing Board or the board has delegated its approval authority. Policy should state the delegation authority. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 57

HOSPITAL TRACKING • A tracking and monitoring system for receiving information regarding hospital or ED admissions. • Identify staff members, by title, who are responsible for receiving ED and hospital admission information. • Implement a mechanism to follow up with the patient, provider, or outside facility to request pertinent medical information related to hospital or E. D. visit. • Policy has been signed and approved by the Governing Board or the board has delegated its approval authority. Policy should state the delegation authority. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 58

2017 DEEMING APPLICATION • Note: Quality Assurance/Improvement and Credentialing & Privileging policies must be approved by the governing board with no delegation of approval authority allowed. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 59

2017 DEEMING APPLICATION • If a deeming application is determined to be incomplete health centers will receive a notice in EHB. • There will be 10 business days to provide missing information. • If required information is not submitted within the 10 days the application will be voided – not reviewed. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 60

QUALITY ASSURANCE • The health center has included a Quality Improvement and Assurance Plan that has been board approved within the last 3 years. • The QI/QA committee minutes demonstrate that QI/QA committee has met at least six times in the past year, or provides a valid explanation if less than six. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 61

QUALITY ASSURANCE • Minutes demonstrate that the health center has clear data-driven performance goals and regularly discusses objectives, action steps, improvement activities and proactive problem identification. • Minutes demonstrate that the health center utilizes a recognized methodology to monitor, analyze, and evaluate their data driven QI/QA projects (i. e. , PDSA). • Minutes demonstrate that the committee has reported its findings and recommendations to the Board at least six times in the past year. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 62

QUALITY ASSURANCE • Minutes from any six Board meetings evidencing oversight of QI/QA activities that took place between April 1, 2015, and the submission date of the application. • Minutes should be redacted to eliminate “all patient and staff identifiers as well as sensitive unrelated material” (PAL 2016 -03). • The health center may also submit health center committee reports that further evidence QI/QA activities. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 63

CREDENTIALING AND PRIVILEGING • PIN 2001 -16: General Statement on BPHC policy regarding credentialing and privileging of health center staff. – “All Health Centers shall assess the credentials of each licensed or certified health care practitioner. ” – “A Health Center must verify that its licensed or certified health care practitioners possess the requisite skills and expertise to manage and treat patients and to perform the medical procedures that are required to provide the authorized services. ” © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 64

CREDENTIALING AND PRIVILEGING • PIN 2002 -22: Clarification of C&P policy with significantly more detail: – Provides definitions. – Explains credentialing requirements in detail. – Explains privileging and re-privileging requirements. – Allows use of Credentials Verification Organization (CVO) to perform credentialing. – Permits temporary privileges but not temporary credentialing. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 65

KEY C&P REQUIREMENTS FROM PIN 200222 • Must credential all licensed or certified health care practitioners. • Credentialing process for licensed independent practitioners (LIP) is rigorous, requiring primary source verification of many items. • Credentialing of non-licensed independent practitioners (e. g. , RNs, LPNs, radiology techs, ultrasound techs, etc. ) requires primary source verification of license only. • Requirements are a minimum. Health centers can do more (e. g. , criminal background checks). © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 66

KEY C&P REQUIREMENTS FROM PIN 200222, CON’T. • Credentialing requirements for LIPs: – Primary source verification of: • • Current license. Relevant education, training and experience. Current Competence. Health fitness or ability to perform the requested privileges. – Secondary source verification of: • • • Government issued picture I. D. DEA registration (as applicable). Hospital admitting privileges (as applicable). Immunization and ppd status. Life support training (as applicable). – NPDB query © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 67

KEY RISK AREAS: CREDENTIALING AND PRIVILEGING Draft and implement clear, written policies. Crosswalk your policy with PIN 2002 -22. Document health center’s compliance. Draft and implement confidentiality policies. Educate practitioners in credentialing and privileging. • Insure board involvement. Should review and approve credentialing policies minimum of every three years. • • • © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 68

KEY RISK AREAS: CREDENTIALING AND PRIVILEGING • Submission of governing board approved policy. Clear evidence of board approval must be present. • Staff list of all licensed and certified staff members providing services at all health center sites and their current credentialing/ privileging status. Make certain all current credentialing dates are within two years of application due date. Double check this! © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 69

KEY RISK AREAS: CREDENTIALING AND PRIVILEGING • Staff list is used to determine if your C&P policy works. • Staff list is not a list of deemed individuals. • Note: Changes to the staff list that occur during the year do not need to be reported to HRSA. • HRSA moving from Excel spreadsheet to EHB format for staff list. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 70

STATEMENT ON PRIOR MALPRACTICE CLAIMS • List of malpractice claims filed over the last five years. • Include FTCA and non-FTCA claims. • Provide name of provider(s), specialty, dates, summary of allegation(s), status and outcome (if known). • Application also requires summary of internal analysis if case not resolved. Assume case is not resolved unless you have documentation from HRSA, HHS/OGC, or DOJ stating that it is resolved (closed). © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 71

2017 DEEMING APPLICATION • 2017 Application continued to require documentation of: – Policies/procedures re: how PAs and APNs and other support staff are supervised; – Medical record policies and procedures; – Periodic review of medical records to determine quality, completeness and legibility; – Periodic assessments to identify, prevent and monitor malpractice risk; – Medical malpractice risk management trainings and related continuing education; and – Board approved continuing education and annual risk management plan. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 72

2017 DEEMING APPLICATION • 2017 Application continues to require that health center has policies/procedures for: – Triage; – Walk-in patients; – Telephone triage; – No show appointments; and – Clinical protocols. • Above policies must be governing board approved or board may delegate approval authority. • None of the above need be submitted with CY 2017 application. • The triage policies may be combined as one policy addressing all triage activities. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 73

2017 DEEMING APPLICATION NUGGETS • A full application must be included for each sub-recipient seeking FTCA coverage. • Application not changeable once submitted. • If application is incomplete you have 10 business days to revise if sent back. You get only one attempt at revising the application to make it complete. • FTCA Reviewers will not contact you for clarification. Application must be clear on its face. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 74

2017 DEEMING APPLICATION NUGGETS • Use the most recently published FTCA Deeming Application Evaluation Self Checklist (aka ‘FTCA Tip Sheet”). Make certain that all the policies/procedures are consistent with the “tip sheet”. Crosswalk “tip sheet” requirements with your policies and procedures. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 75

DEEMING APPLICATION RESOURCES • 2017 FTCA Deeming Application Self Evaluation Checklist: http: //bphc. hrsa. gov/ftca/healthcenters / selfchecklist. pdf • ECRI: https: //www. ecri. org/components/hrsa / Pages/default. aspx • FTCA Subscription Services: www. healthcentercompliance. com © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 76

FTCA PART 4 May 8, 2017 1: 30 pm – 2: 30 pm © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 77

FEDERAL TORT CLAIMS ACT PROGRAM Department of Justice Proposed Rule on De-deeming of Individual Health Center Practitioners © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 78

FTCA PROPOSED RULE: “DE-DEEMING” • NEW: Department of Justice (DOJ) Proposed Rule Determination That an Individual Shall Not Be Deemed an Employee of the Public Health Service regarding “de-deeming” released March 6, 2015 – Explains and interprets section 233(i) of the Federally Supported Health Centers Assistance Act, which authorizes the Attorney General, (AG) in certain circumstances, to bar an individual clinician from participation in the FTCA program – Proposed rule outlines criteria and a process by which the DOJ can determine that an individual shall not be deemed an employee of the Public Health Services for purposes of FTCA as it may expose the Government to an unreasonably high degree of risk of loss – Comments must be submitted on or before May 5, 2015 © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 79

FTCA PROPOSED RULE: “DE-DEEMING” • Proposed criteria, which mirror the statute, include one or more findings that the individual: – Did not comply with procedures set by the health center to reduce the risk of malpractice – Has a history of malpractice claims filed against him or her (outside the norm for similarly licensed or certified providers in that specialty) – Refused to reasonably cooperate with the Attorney General (AG) in defending the claim – Provided false information relevant to his or her duties in relation to the claim – Was the subject of disciplinary action taken by a state medical licensing authority or a state or national professional society • Rule provides for due process in connection with a proposed determination to “de-deem” an individual © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 80

FTCA PROPOSED RULE: “DE-DEEMING” • Proposed Process for making a determination to “dedeem” an individual: – Using the proposed criteria, a DOJ “Initiating Official’’ makes a determination that treating an individual as an employee of the Public Health Service for FTCA purposes may expose the Government to an unreasonably high degree of risk of loss. – After consultation with the Secretary of DHHS, the DOJ Initiating Official notifies the individual that an administrative hearing will be held. – Both parties have a brief period for discovery and depositions, to the extent allowed by an administrative law judge (ALJ). © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 81

FTCA PROPOSED RULE: “DE-DEEMING” • Proposed Process for making a determination to “de-deem” an individual: – ALJ conducts a hearing, submits written findings of fact, conclusions of law, and a recommended decision to the “Adjudicating Official”. – Parties have 30 days to submit certain additional materials in response to the ALJ’s findings and recommendations. – Adjudicating Official makes a final agency determination. – Individual may seek a rehearing if (s)he disagrees with the determination and, if unsuccessful, may apply for reinstatement after a period of time. – DOJ will notify the National Practitioner Data Bank (NPDB) of the issuance of a final order deeming an individual not to be an employee of the Public Health Service under this rule. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 82

FTCA PROPOSED RULE: “DE-DEEMING” • Initial concerns about the criteria and process under the proposed rule: – What constitutes an unreasonably high degree of risk of loss? – What is “outside the norm”? – How many claims constitute a “history” of malpractice claims? – What does it mean to be the “subject” of disciplinary action? What if an individual was not, in fact, disciplined? – Is notification to the National Practitioner Data Bank (NPDB) an appropriate sanction when de-deeming an individual? © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 83

FTCA Claims Process © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 84

FTCA CLAIMS PROCESS/PROCEDURE © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 85

FTCA CLAIMS PROCESS/PROCEDURE Terms of Art • • • Administrative Claim SF-95 State Court Claim (“preemie”) Removal Statute of Limitations © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 86

FTCA CLAIMS PROCESS/PROCEDURE What’s an FTCA administrative claim? A claim against the United States under the Federal Tort Claims Act for property damage, personal injury, or death allegedly caused by a federal employee’s negligence or wrongful act or omission occurring within the scope of the employee’s federal employment. A claim shall be deemed to have been presented when a federal agency (HHS) receives from a claimant, his duly authorized agent, or legal representative, an executed Standard Form 95 or other written notification of an incident, accompanied by a claim for money. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 87

FTCA CLAIMS PROCESS/PROCEDURE © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 88

FTCA CLAIMS PROCESS/PROCEDURE © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 89

FTCA CLAIMS PROCESS/PROCEDURE How the Claims Process Should Work: • The plaintiff files an administrative claim against the United States. • The HHS Office of General Counsel (OGC) notifies the health center about the claim and the health center provides OGC with all of the necessary documentation. • HHS gets expert opinion of standard of care. • HHS reviews the claim and may deny it, pay it, or offer a settlement. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 90

FTCA CLAIMS PROCESS/PROCEDURE How the Claims Process Should Work: • If HHS denies the claim or does not act on a claim within six months, the plaintiff may file a lawsuit in federal court. • When suit is filed, the case is transferred from DHHS to the Department of Justice (DOJ). DOJ may attempt to settle the suit, otherwise the lawsuit will proceed in litigation against the United States in federal court. • If payment is made on an FTCA claim, the Medical Claims Review Panel determines whether the standard of care was met for purposes of National Practitioner Data Bank reporting. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 91

FTCA CLAIMS PROCESS/PROCEDURE How the Claims Process Usually Works: • The plaintiff files a medical malpractice lawsuit against the health center in state court (referred to as a “premature lawsuit” or “preemie”). • The health center notifies HHS Office of General Counsel (OGC) about the lawsuit and provides OGC with all of the necessary documentation as quickly as possible. • The health center proceeds in state court (motions to extend deadlines, etc…) while waiting for the OGC to verify the applicability of the FTCA to a particular claim. • HHS verifies the applicability of the FTCA to a claim and refers the case to the DOJ, who assigns an Assistant U. S. Attorney to the case. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 92

FTCA CLAIMS PROCESS/PROCEDURE How the Claims Process Usually Works (cont’d): • The AUSA removes the case to federal court and files a motion to dismiss the case against the health center. • The U. S. District Court dismisses the health center from the case and substitutes the United States as the defendant. • The AUSA moves to dismiss the case against the United States for the plaintiff failing to exhaust his/her administrative remedies. • The U. S. District Court dismisses the case against the United States and the case proceeds as an FTCA claim as described in the “How the Claims Process Should Work” slide. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 93

FTCA CLAIMS PROCESS/PROCEDURE NARRATIVE STATEMENT © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 94

FTCA CLAIMS PROCESS/PROCEDURE • • • OGC LITIGATION HOLD LETTER Identify all employees who have information related to the litigation and provide it to OGC. Issue written notification to all health center employees (sample litigation hold notice provided by OGC). Identify and provide OGC with a list of relevant health center IT and HIMS supervisors who have responsibility for IT systems. Send IT Department litigation hold memo and discuss record retention, backup practices and related items. Provide OGC with information related to the health center’s document retention policies. Re-issue litigation hold notice to all health center employees every three months. Provide OGC with a copy of the health center’s litigation hold notice. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 95

FTCA CLAIMS PROCESS/PROCEDURE OGC LITIGATION HOLD LETTER • • All medical records. All billing records. All communications between patient and health center (and any of its employees). All communications between any third party and the health center (and any employees concerning patient’s medical care and treatment). All records pertaining to health center’s employee(s) named in the complaint licensure, certification, and employment history with the health center, including any personnel files maintained by the health center. Any documentation the health center and/or its employees distributed to the patient. Any policies of the health center in effect during the time the patient was being treated by the health center that bear upon standards for medical treatment. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 96

FTCA CLAIMS PROCESS/PROCEDURE Who to Contact if You Receive Notice of a Claim or Lawsuit: U. S. Department of Health and Human Services Office of the General Counsel General Law Division 330 C Street SW Switzer Bldg, Suite 2600 Washington D. C. 20201 202 -691 -2369 202 -619 -2035 (fax) HHS-FTCA-Claims@hhs. gov **IMPORTANT- CONFIRM RECEIPT OF ALL DOCUMENTS E-MAILED OR FAXED. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 97

MEDICAL CLAIMS REVIEW PANEL Purpose: The MCRP assists HHS in meeting its responsibility to provide quality health care in its facilities and by its practitioners. The collective clinical knowledge and expertise of the membership shall be applied to the review of claims of medical negligence and substandard practice, addressing issues such as standards of care and provider competence. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 98

MEDICAL CLAIMS REVIEW PANEL Function: • Review and evaluate analyses performed by HHS or consultant physicians and other health care professionals on claims for damage, injury, or death filed under the FTCA against an HHS facility or health care practitioner covered under the FTCA. • After a claim has been paid pursuant to a settlement or adverse judgment, identify the clinician(s) who provided the treatment giving rise to the claim and determine whether the standard of care was breached. • Provide professional recommendations to HHS clinical programs and personnel systems on matters of quality assurance and risk management activities, within the context of cases reviewed. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 99

MEDICAL CLAIMS REVIEW PANEL Reports: The Chairperson of the MCRP shall transmit a report to the Claims Officer on each claim reviewed. This report shall include the name(s) of the provider(s) who provided the treatment giving rise to the claim for use in the event of a report to the NPDB. In the event the Panel determines that the adverse event was the result of a systems failure, no provider of record shall be named. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 100

MEDICAL CLAIMS REVIEW PANEL • MCRP Reconsideration Policy and Procedure under review at the department level. • No formal reconsideration process in place at this time. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 101

NPDB – MEDICAL MALPRACTICE • All malpractice payments, in any amount, made for the benefit of any type of licensed practitioner: • Both settlements and judgments. • No dollar threshold for reporting. • A report does not mean that actual malpractice occurred, only that a payment was made. • HRSA voluntarily participates in the NPDB. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 102

NPDB – HRSA REPORTING TO NPDB • In general, if the HHS Medical Claims Review Panel reviews an FTCA claim and finds that the standard of care was met, despite a payment being made in settlement of the claim, that payment is not reported to the NPDB. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 103

HANDLING SUBPOENAS - TOUHY REGULATION • 45 CFR Part 2. • Prohibits federal employees (THAT MEANS YOU) from giving testimony without prior approval from the HRSA Administrator. • Applies to current and former employees and qualified contractors of covered entities with respect to testimony for medical malpractice tort litigation that related to the performance of medical, surgical, dental, or related functions performed while the health center and its covered individuals were covered by FSHCAA. • DOES NOT APPLY to: – Any civil or criminal proceedings where the United States or HHS is a party. – Employees making appearances in their private capacity in legal or administrative proceedings that do not relate (traffic accidents, crimes, domestic relations). – Any civil or criminal proceedings in state court brought on behalf of HHS. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 104

HANDLING SUBPOENAS - TOUHY REGULATION • • Fax subpoenas to HHS OGC CELB U. S. Department of Health and Human Services Office of the General Counsel/General Law Division 330 C Street SW Switzer Bldg, Suite 2600 Washington D. C. 20201 202 -691 -236 9202 -619 -2035 (fax) HHS-FTCA-Claims@hhs. gov HHS OGC determines if Touhy regulation applies. If Touhy regulation applies and HRSA Administrator denies approval for the health center provider to comply with a subpoena for testimony or if the HRSA Administrator does not act by the deadline, the health center provider must: (1) appear at the stated time and place unless advised by OGC that responding would be inappropriate; (2) produce a copy of Touhy regulations; and (3) respectfully decline to testify or produce any documents on the basis of the regulations. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 105

FTCA PART 5 May 8, 2017 2: 45 PM – 3: 45 PM © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 106

FTCA Case Law: Background © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 107

CASE LAW: FEDERAL LAW PRIMER U. S. Constitution 42 U. S. C. § 233 y Federall ed Support enter Health C Act ce Assistan Statutes art 6 P R F C s for n 42 o i s s i and Om s t c A d nters e C Covere h t l Hea ) 14 -02 0 2 # al (PIN u n a ge for a M r y e c v i l o Po TCA C -03) F FTCA r o f ents 2016 m # e L r i A u P Req ters ( n e 2017 C h Healt Regulations Guidance © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 108

CASE LAW: FEDERAL LAW PRIMER 42 U. S. C. 233 Statute “scope of employment" 42 CFR Part 6 Regulations “grant supported activity” Policy Manual “scope of project” © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 109

CASE LAW: FEDERAL LAW PRIMER Administrative Procedure Act The reviewing court shall— (1) compel agency action unlawfully withheld or unreasonably delayed; and (2) hold unlawful and set aside agency action, findings, and conclusions found to be— (A) arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law; (B) contrary to constitutional right, power, privilege, or immunity; (C) in excess of statutory jurisdiction, authority, or limitations, or short of statutory right; (D) without observance of procedure required by law; (E) unsupported by substantial evidence in a case subject to sections 556 and 557 of this title or otherwise reviewed on the record of an agency hearing provided by statute; or (F) unwarranted by the facts to the extent that the facts are subject to trial de novo by the reviewing court. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 110

CASE LAW: CONTINUUM OF FTCA HRSA Policy Guidance, regulations & law support action taken by health center Regulations &/or law support action taken by health center No clarity in the regulations or law © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 111

CASE LAW: COST/BENEFIT ANALYSIS Try mightily to live up to HRSA policy and be compliant with all PINS, PALS, guidance documents, etc…. BUT If you fail, there ARE options © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 112

NEGATIVE DECISIONS OF AGENCY • Denial of Deemed Status: – Rejecting deeming application, or – Revoking deeming after FTCA Site Visit. • Denial of FTCA Coverage in Medical Malpractice Claim: – Office of General Counsel determines that a particular malpractice claim is not covered by the FTCA, or – DOJ refuses to defend a claim that HHS OGC determines is covered by FTCA. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 113

FTCA Case Law: Denial of Deemed Status © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 114

DEEMING REQUIREMENTS 42 U. S. C. § 233(h) requires HRSA, as a condition of deeming an entity to be a PHS employee, to determine that the entity is compliant with the following standards: • The entity must implement appropriate policies and procedures to reduce the risk of malpractice and the risk of lawsuits arising out of any health or health-related functions, • The 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 and, where necessary, has obtained the permission from these individuals to gain access to this information, © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 115

DEEMING REQUIREMENTS (CONT’D) • The entity must have no history of claims having been filed against the United States as a result of the application of [FSHCAA] to the entity or its [covered individuals], or, if such history exists, has fully cooperated with the Attorney General in defending against any such claims and either has taken, or will take, any necessary corrective steps to assure against such claims in the future, • The entity must cooperate fully with the Attorney General in providing information on claims. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 116

EXAMPLE: DENIAL OF DEEMING APPLICATION • Operative Facts: – Health center submits a deeming application to HRSA pursuant to the current year’s PAL (e. g. , PAL #201603). – HRSA initially denies application and gives health center time to resubmit a corrected one. – Health center resubmits corrected deeming application. – HRSA denies the deeming application. – Health center has no FTCA coverage and must go out on the private market to purchase coverage. • Rest of the Story. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 117

EXAMPLE: DENIAL OF DEEMING APPLICATION • Is the denial arbitrary & capricious? – Is the Agency’s decision based on law or regulations? – Has the Agency taken inconsistent positions in similar matters? – Has the Agency departed from longstanding custom and practice? – Did the Agency fail to examine relevant information that the health center submitted in support of its application for coverage? – Did the Agency have the authority to deny the application on those grounds? – Did the Agency articulate a rational basis for its denial? • Is denial contrary to law? – Was the coverage determination made in 30 days? © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 118

HRSA ON DEEMING APPLICATIONS THEN. . . PAL 2012 -02 stated: It is HRSA’s goal to support all health centers in successfully demonstrating compliance with and implementation of these requirements. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 119

HRSA ON DEEMING APPLICATIONS NOW. . . PALs 2013 -05 and 2014 -03 contain the following: Please note that 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 and further described in this PAL. Applications that do not meet the applicable requirements in the evaluation of the program will not be approved, and affirmative deeming determinations will not be issued. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 120

FTCA Case Law Denial of FTCA Coverage for a Malpractice Claim © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 121

EXAMPLE: DENIAL OF FTCA COVERAGE FOR CLAIM • Operative Facts: – Patient files lawsuit in state court against health center and its physicians for alleged malpractice. – Health center asks HHS for FTCA coverage for itself and its physicians. – HHS agrees that the alleged malpractice is covered by FTCA and asks the US Department of Justice (DOJ) to remove the case to federal court and substitute the United States as the defendant. – DOJ believes that the health center and physicians are not covered by FTCA and refuses to remove the case. – Health center removes case to federal court itself. – DOJ fights the removal and asks the federal court to remand the case back to state court. • Rest of the Story © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 122

EXAMPLE: DENIAL OF FTCA COVERAGE FOR CLAIM • Is HHS’s favorable coverage determination final and binding on DOJ? • Are the services provided to the patient covered by FTCA? • Is the health center site an “FTCA covered” site? • Is the patient a “health center patient? ” © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 123

EXAMPLE: DENIAL OF FTCA COVERAGE FOR CLAIM Court’s Decision… “Because Ms. X was a patient of ABC with respect to the services at issue in this case, and because it is undisputed the other requirements for FTCA coverage are met in this case, Defendants are entitled to FTCA coverage with respect to the acts and omissions giving rise to Plaintiff’s malpractice claims. ” © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 124

OTHER CASES IN THE PIPELINE • Disclosure of protected health information of health center employee/breach of confidentiality • Coverage of case management services (especially housing assistance) • Coverage of care provided to a health center patient when site does not appear in Form 5, Part B • Coverage of health center physician for care provided when default judgment is entered in state court. • Coverage of health center physician when physician bills for service. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 125

ANOTHER IMPORTANT EXAMPLE: EL RIO V. U. S. • Health center contracts with obstetricians through their professional corporation. • Each individual physician signs a contract with the health center guaranteeing the performance of the contract with the corporation. • Suit is filed in state court alleging malpractice on part of the physicians. • HHS denies FTCA coverage because physicians had contracted with health center through their professional corporation. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 126

OTHER ISSUES ON THE HORIZON? • Particularized Determinations • 42 U. S. C. 233(g)(1)(C) (Secretary’s approval of care to non-health center patients via the deeming application) v. particularized determination process in PIN 2014 -02. • Failure to act on particularized determination requests. • Peer Review Privilege • Lack of federal peer review privilege. • Disagreement in the courts on application of state law privilege. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 127

CASE LAW: PRACTICE TIPS • If HHS/DOJ denies FTCA coverage for an activity that the health center should be doing (i. e. , a traditional health center activity), then that denial is likely WRONG. In many cases, adverse decisions are vulnerable because they are based on guidance documents and not statutes and regulations. • YOUR WORDS MATTER (e. g. , grant application narrative, change in scope request, deeming application, particularized determination). © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 128

Proposed Compliance Manual © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 129

PROPOSED COMPLIANCE MANUAL Proposed health center compliance manual: • Comments were due Nov. 22, 2016. • Supersedes some prior PINs and PALs. • Proposes minor changes to C & P policy. • Includes chapter on Deeming Applications that may or may not conflict with future FTCA issuances. • FTCA changes to be incorporated in 130 © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com

Gap Insurance © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 131

GAP INSURANCE • Benefits of Gap Insurance – Can provide broad coverage for beyond FTCA. – Provide access to risk management services. – Can assist in management of claims. © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 132

GAP INSURANCE • Limitations of Gap Insurance: – Claims of discrimination – Violations of civil rights – Violations of the federal Anti-Kickback statute or False Claims Act – Breach of electronic data security – Violations that result in a fine, penalty, or other sanction – Certain criminal or intentionally wrongful acts © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 133

GAP INSURANCE • Limitations of Gap Insurance: – Acts covered by the FSHCAA and the FTCA • If dual coverage exists, the United States has a right of subrogation with respect to any FTCA claims. 42 U. S. C. § 233(g)(2). – Violations of any statute, ordinance, or regulation that result in a fine, penalty, or other sanction (including attorney fees) – Employees or facilities not named in the policy – Audits or investigations © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 134

GAP INSURANCE BUT: While certain claims may not be covered under the basic gap insurance policy, the health center may be able to add coverage for various claims, employees, or facilities not included in the basic policy in the form of a rider to the policy © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 135

CONTACT INFORMATION Martin J. Bree MBree@FTLF. com 202 -466 -8960 © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 136

CONTACT INFORMATION Feldesman Tucker Leifer Fidell, LLP 1129 20 th St. NW Washington, D. C. 20036 (202) 466 -8960 www. FTLF. com www. Health. Center. Compliance. com © 2017 Feldesman Tucker Leifer Fidell LLP. All rights reserved. | www. ftlf. com 137