Section Four MALPRACTICE FEDERAL TORT CLAIMS ACT FTCA

Section Four: MALPRACTICE, FEDERAL TORT CLAIMS ACT (FTCA) AND RISK MANAGEMENT Disclaimer: The materials for this Training were prepared by the National Association of Community Health Centers, Inc. (“NACHC”). The Training is designed to provide accurate and authoritative information in regard to the subject matter covered. However, it is being made available with the understanding that neither NACHC nor the Authors nor the Trainers are engaged in rendering legal or other professional advice and that the information presented does not constitute, and is not a substitute for, specific legal, professional or other expert advice. If legal advice or other expert assistance is required, the services of a competent professional should be sought after this Training.

Federal Tort Claims Act (FTCA): Background History of Medical Malpractice Coverage • Commercial insurance • Malpractice crisis of 1980 s • Return of commercial market in 1990 s • “Hardened market” in 2000 • State by state crisis 2003 2

FTCA Background (cont'd) Traditional Malpractice Insurance • “Claims Made” • “Occurrence” • “Tail Coverage” • “Nose Coverage” • “Gap Coverage” 3

FTCA: History • FTCA creates tort liability for actions of employees of U. S. • 1992 Federally Supported Health Centers Assistance Act (P. L. 102 -501) extended FTCA coverage to section 330 grantees who submit an FTCA application and meet statutory requirements • 1995 FSHCAA (P. L. 104 -73) made FTCA coverage permanent and clarified coverage 4

FTCA: History (cont'd) • As a result of these laws, health center employees “deemed” as federal Public Health Service employees • Provides immunity from lawsuits alleging medical malpractice (medical, surgical, dental, and related activities) • Plaintiffs’ only remedy is claim under FTCA 5

Deeming and Redeeming Your Executive Director requests that you assist with the Deeming or Redeeming application for your health center. • Why would they need a clinician to spend time on this administrative task? • What are some key areas that will need your attention? 6

FTCA: Deeming • Eligible Entities (330 funded) ü Migrant Health Centers ü Community Health Centers ü Health Care for the Homeless Programs ü Health Services in Public Housing ü School-Based Health Centers 7

FTCA: Deeming (cont'd) • “The Health Center Program: Policy Information Notice 2014 -02: Updated Federal Tort Claims Act (FTCA) Health Center Policy Manual” • “The Health Center Program: Program Assistance Letter (PAL) 2016 -03: Calendar Year 2017 Requirements for Federal Tort Claims Act (FTCA) Medical Malpractice Coverage for Health Centers • Ineligible Entities: ü Federally Qualified Health Center (FQHC) ‘Look-Alikes’ 8

FTCA: Deeming (cont'd) • Requirements: ü Credentialing and privileging of all licensed or certified health care providers • See Bureau of Primary Health Care (BPHC) Policy Information Notices (PINS) 2001 -16, 2002 -22, 2011 -01 (This Policy is applicable to all health centers deemed or not). ü Applies to all health center practitioners (employed or contracted), volunteers (not covered), contractors and locum tenens ü Querying National Practitioner Data Bank (NPDB) 9

FTCA: Deeming Applications • All health centers must apply to participate in FTCA program • Applications are submitted via Electronic Handbooks (EHB) • New applicants may submit at any time except when EHB is down for maintenance (typically January –April) • Re-deeming applications for CY 2017 are due May 24. 10

FTCA: Deeming Requirements (cont’d) • QI/QA Plan, board approved in last 3 years • Minutes of last 6 QI/QA committee meetings (redacted to remove patient and staff names) • Minutes of last 6 board meetings reflecting approval of QI/QA activities (redacted to remove patient and staff names and other non-relevant information) • Credentialing and privileging policies and procedures • List of all licensed and certified staff members, employed or contracted practitioners, locum tenens, and volunteers with evidence of credentialing in last 2 Y • Policies and procedures for 1) referrals tracking; 2) hospitalization tracking; and 3) diagnostic (x-ray & lab) tracking; 11

FTCA: Who is Covered? • Health center officers, governing board members, or employees (volunteers are not employees; employees who get a W-2 at year-end) • Full-time contractors (average of 32. 5 hours or more per week) • Part-time contract providers of services (<32. 5 hours/week): Primary Care: Family Practice, OB/GYN, General Internal Medicine, or General Pediatrics • Contracts must be between the health center and the individual provider (1099) 12

FTCA: Who Is Not Covered? • Volunteers – note: the 21 st Century Cures Act created a new program for FTCA coverage for volunteers in health centers. Until regulations and/or guidance are issued this new program is not in effect. • Residents • Providers billing directly ü See Bureau of Primary Health Care (BPHC) Federal Tort Claims Act (FTCA) Health Center Policy Manual • Part-time contract providers not in primary care specialties • Health professional students 13

FTCA: Who Is Not Covered? (cont'd) • Contracts between a deemed health center and a corporation (including “Dr. X. Y. Zed P. C. ” This is not an employee but a Private Corporation named Dr. X. Y. Zed) • Third parties seeking indemnification • Providers acting outside the health center federal scope of project or employment agreement • Sub-grantees* *A sub-grantee can apply to be deemed through its grantee and therefore have FTCA coverage 14

FTCA: What Is Covered? • Medical malpractice (medical, surgical, dental or related functions – 42 U. S. C. 233(a)) • Act or Omissions related to the grant supported activities (45 CFR Part 6. 6(d)) • Activities within approved scope of federal project only ü See Bureau of Primary Health Care (BPHC) Policy Information Notice (PIN) 2008 -01 • Activities within scope of employment or health center duties 15

FTCA: What Is Covered? (cont'd) • Activities on or after deeming date • Services to certain non-health center patients when approved by the Secretary DHHS • Request ‘Particularized Determination’ of services to non-patients from HHS, if necessary 16

FTCA: What Is Covered? (cont'd) • Covered Non-Health Center Patients ü Participants in screening or health fairs (if this is in your scope on form 5 c) ü After hours patients you see for a cross-covering practice (if you are required to see them by hospital policy and your employment contract) ü Unassigned ED patients (if you are required to see them by hospital policy and your employment contract) 17

FTCA: Other Provisions • No dual coverage; gap or wrap-around insurance acceptable • Hospitals and managed care plans must accept FTCA coverage • Protection only from personal injury or death resulting from performance of surgical, medical, dental or related functions 18

Hiring A resident who has worked in your health center is graduating next June and would like to know about FTCA and how it would compare to the private practice option that is his other possible opportunity. What would you want to highlight? 19

Recruiting • Advantages for a prospective provider – Provides immunity from lawsuit – No tail – Occurrence coverage – Part time work is possible – Medical Claims Review Panel 20

FTCA: Implementation Advantages to Health Centers • No cost to individual centers (No direct cost) • No dollar limit on liability • Decreases “frivolous” lawsuits ü Health and Human Services (HHS) Review the claims that are filed before a lawsuit is permitted ü Plaintiff’s attorneys prefer Jury vs. Federal Judge 21

Medical Claims Review Panel • Activated after relief (payment) is provided by settlement or court judgment • Provides review to determine if the National Practitioner Data Bank (NPDB) report is warranted • May name an individual NOT named in the request for relief or suit 22

FTCA: Implementation (cont'd) Concerns to BPHC • Clear “scope of project” definition (center) • Clear “job description” definition (provider) • Demand on FTCA Judgment Fund as participation grows and claims increase 23

Credentialing Once the resident has signed his/her offer letter what do you need to do to bring them onboard? What time pressures might you face? 24

New Provider • State license is usually the rate limiting step • How often does your state grant licenses? • Hospital privileges • Insurance plan approval • State Medicaid/Medicare approval 25

FTCA: Implementation (cont'd) Credentialing and Privileging • • A “critical issue” for health centers Directly impacts the FTCA program BPHC Guidance Definitions ü ü “Credentialing” – Who they are “Privileging” – What they can do Credentialing & Privileging PIN 2001 -16 Credentialing and Privileging PIN 2002 -22 26

FTCA: Implementation (cont'd) Credentialing and Privileging (cont'd) • Definitions (cont'd) ü Organizational “leaders” ü Credentialing and privileging authority ü Licensed Independent Practitioners (LIPs) ü Other licensed or certified practitioners ü Primary source verification 27

FTCA: Implementation (cont'd) Credentialing and Privileging (cont'd) • E-Credentials • An Effective Program ü Highly structured ü Formal ü Timely ü Re-privileging process ü Denials and appeals process ü Provider involvement and education 28

Scope of Project A board member and a provider come to you with a request to fill a specific need identified in your community. Are there any FTCA implications for adding the service? • What concerns might this raise? • How would you address these? 29

FTCA: Scope Of Project • Covers only incidents that occur within the scope of project üSee Bureau of Primary Health Care (BPHC) Policy Information Notice (PIN) 2008 -01 • Scope of project refers to activities described in the grant application that was approved via notice of grant award üIncludes any changes in scope of project approved after the original notice of grant award. üSites and services are key elements of scope of project üSummarized in EHB Forms 5 A, B, & C. 30

FTCA: Scope of Project (cont'd) • Separate process for requesting changes in scope of project • Changes in sites and services require prior approval • Pay attention to scope of project! 31

Touhy Regulation • A provider receives a subpoena to appear in court on behalf of a patient in an injury case. • Are there any FTCA implications, and if so what are they? 32

Touhy Regulation (cont’d) • Touhy regulation (45 CFR Part 2)(2008) prohibits Federal employees from giving testimony without prior approval from the HRSA Administrator • Applies to current & former employees and qualified contractors (covered under FTCA) regarding testimony for medical malpractice Ø “Information acquired in the course of performing official duties or because of the person's official capacity”, FTCA Policy Manual 33

Touhy Regulation (cont’d) • Applies to: civil proceedings involving allegations of medical malpractice where you or the United States is not a party • Determination: transmit subpoenas and requests for testimony to DHHS Office of the General Counsel (OGC) General Law Division (GLD) • Health and Human Services Office of the General Counsel will arrange Department of Justice (DOJ) representation or will deny request for testimony 34

Touhy Regulation (cont’d) • If HRSA denies or does not meet deadline: • • • Appear at stated time and place Produce Touhy regulations Respectfully decline to testify • FTCA Manual, Pages 23 -24 • Subpoenas and requests for testimony: ü DHHS Office of the General Counsel (OGC) General Law Division (GLD) Phone: (202) 691 -2369 Fax: (202) 619 -2922 E-mail: HHS-FTCA-Claims@hhs. gov 35

Risk Management • A provider calls you after a patient has an unexpectedly bad outcome. What steps should you take with: ü The medical record? ü Your attorney? ü Risk management? ü Quality improvement? 36

Risk Management (cont’d) Areas of Importance • Quality Management • Credentialing and Privileging • Clinical Management • Patient Records • Patient Communications • Incident Tracking and Reporting 37

Risk Management (cont'd) Risk Concern Areas ü Use of protocols ü Medical record documentation ü Credentialing and privileging ü Referral issues ü OB/GYN, procedures, failure to diagnose 38

NACHC Risk Management Resources • Clinical Issues/Risk Management http: //www. nachc. org/clinical-matters/clinical-quality/risk-management/ • ECRI Institute https: //www. ecri. org/Pages/default. aspx • Health Center Compliance. com https: //www. healthcentercompliance. com/ 39

FTCA: Final Words • FTCA and solid Risk Management is A Winning Partnership • An Effective Risk Management Program is: ü ü ü Structured Comprehensive Organization-wide Leader supported Legally sound “Top of Mind” 40

Key Link • HRSA – FTCA for Health Centers: Key Resources in Supporting Quality Care http: //bphc. hrsa. gov/ftca/index. html ü FTCA Policies ü Application Process ü Particularized Determination ü Health Center Claims ü FTCA for Health Center FAQs ü Risk Management Resources 41

Key Takeaways Takeaway 1: Credential and privilege your staff. Takeaway 2: Pay attention to scope. Takeaway 3: Be proactive when an incident occurs. Takeaway 4: Keep “FTCA Health Center Policy Manual” where you can find it, and read it yearly (http: //bphc. hrsa. gov/ftca/pdf/ftcahcpolicymanualpdf. pdf) Please note that while these are the “key takeaways, ” they are just that. All other information in this section also is important, relevant, and useful. 42

Additional Resources National Practitioner Data Bank (NPDB) http: //www. npdb. hrsa. gov/ HRSA FTCA Health Center Policy Manual http: //bphc. hrsa. gov/ftca/pdf/ftcahcpolicymanualpdf. pdf Health Center Compliance. com https: //www. healthcentercompliance. com/ 43

Additional Resources (cont’d) Bureau of Primary Health Care (BPHC) Policy Information Notices (PINs) & Program Assistance Letters (PALs) PIN 2001 -16: Credentialing and Privileging of Health Center Practitioners http: //bphc. hrsa. gov/programrequirements/pdf/pin 200116. pdf PIN 2002 -22: Clarification of Credentialing and Privileging Outlined in PIN 2001 -16 http: //bphc. hrsa. gov/programrequirements/pdf/pin 200222. pdf 44

Additional Resources (cont’d) PIN 2008 -01: Defining Scope of Project and Policy for Requesting Changes http: //bphc. hrsa. gov/programrequirements/pdf/pin 2008 -01. pdf PAL 2016 -03: Calendar Year 2017 Requirements for Federal Tort Claims Act (FTCA) Coverage for Health Centers http: //bphc. hrsa. gov/programrequirements/pdf/pal 201603. pdf 45