1. FTCA MEDICAL MALPRACTICE BASICS AND PROGRAM UPDATES Christopher W
FTCA MEDICAL MALPRACTICE BASICS AND PROGRAM UPDATES Christopher W. Gibbs, JD, MPH
Department of Health and Human Services
Health Resources and Services Administration
Bureau of Primary Health Care
Office of Quality and Data

2. Introduction FTCA Basics: The Who, When, Where, What, and How
FTCA Program Update
Summary of Deeming Requirements: Changes and Lessons Learned from CY 2012 Deeming
Helpful Resources and Technical Assistance
Question and Answer

3. How the Program Works A program that provides immunity from lawsuit.
Appears similar to an occurrence malpractice policy.
Very successful in terms of savings for health centers and coverage of health centers and staff.

4. How the Program Works (continued)
Under FSHCAA Health Centers are eligible to be deemed “federal employees”.
Provides immunity from lawsuit alleging medical malpractice.
Plaintiff’s only remedy is claim under Federal Tort Claims Act (FTCA).

5. How the Program Works (continued)
Who, what, when, where?
Who is covered - Relationship to Health Center.
What is covered – medical malpractice.
Where is it covered – scope of project.
When is it covered – scope of employment.

6. How the Program Works (continued)
Who is Eligible to be Deemed:
Community Health Centers [section 330 (e)].
Migrant Health Centers [section 330 (g)].
Health Care for the Homeless [section 330 (h)].
Public Housing Primary Care [section 330 (i)].

7. How the Program Works (continued)
Who is covered
Employees.
Officers.
Directors.
Governing board members.
Contractors (some, not all).

8. How the Program Works (continued)
Who is covered - Employees
All employees, full time or part time.
Volunteers are not employees.
Employees get a W-2 at end of year.

9. How the Program Works (continued)
Who is covered - Contractors
Any full time contract provider (over 32 1/2 hours per week).
Part time contract provider of services in the fields of family practice, ob-gyn, general internal medicine, or general pediatrics.
Contract must be between the deemed health center and the individual provider.
Contracts between the deemed health center and a corporation (including Professional Corporations) are not covered.

10. How the Program Works (continued)
What is covered?
Medical malpractice.
More specifically, medical, surgical, dental and related activities (if within the scope of employment and scope of project).

11. How the Program Works (continued)
Where is it covered – within the scope of project
Only incidents that occur within the scope of the project are covered. (See Policy Information Notice ).
Scope of Project are the activities described in the grant application that are approved by Public Health Service via Notice of Grant Award.
An existing Scope of Project can be changed by applying for a Change in Scope (CIS).

12. How the Program Works (continued)
When is it covered
Coverage is only for acts that are within the scope of employment of the covered individual.
No Moonlighting.
Must be acting on behalf of the deemed entity.

13. Non-Health Center Patients
Federal Register Notice September 25, 1995 (Volume 60 Number 185) page –
Community-Wide Intervention School-Based Clinics
School-linked Clinics
Health Fairs
Immunization Campaigns
Migrant Camp Outreach
Homeless Outreach
Hospital Related Activities
Coverage-Related Activities
Other situations require a “Particularized Determination” PIN
Application Information for PDs is located on page 9 and 10

14. Notice of Proposed Rule Making
Proposal to amend regulations at 42 CFR Part 6 (“FTCA Coverage of Certain Grantees and Individuals”)
Immunization campaigns for all, not just children (as currently stated)
FTCA coverage for services provided to non-health center patients in individual emergency situations
A health center provider is acting to provide care to a health center patient (and such care is part of the approved scope of project of the center) and the provider is then asked, as the result of a non-health center patient’s emergency situation, to temporarily treat or assist in treating that non-health center patient at that location. The health center has documentation (such as employee manual provisions, health center bylaws, or employee contract) that the provision of individual emergency treatment (when the practitioner is already on-site acting to provide care to health center patients) is a condition of employment at the health center.
The Rule is in the final clearance stage

15. FTCA CLAIMS PROCESS

16. FTCA Claims Procedures
Plaintiff files administrative claim against the United States.
DHHS reviews claim and may deny it, pay it or offer a settlement.
If DHHS denies claim plaintiff may file suit.
If DHHS does not act on claim within six months plaintiff may file suit.
When suit is filed case transferred to DOJ.
DOJ may attempt to settle suit otherwise it goes into litigation.

17. FTCA Claims Procedures (continued)
Plaintiffs often file suit in state court (Premature Claims).
What to do:
U.S. Department of Health and Human Services
Office of the General Counsel
General Law Division
330 Independence Avenue, S.W.
Mail Stop Capitol Place
Washington, DC 20201
(fax)
Have health center attorney request extension of time to reply.

18. FTCA PROGRAM UPDATES

19. Program Updates FTCA Branch FTCA Policy Manual (PIN 2011-01)
Branch within OQD
6 staff members
Acting Branch Chief: Naomi Tomoyasu
Focus on FTCA policies, procedures, risk management, presentations, TA and program development for Health Centers and Free Clinics
FTCA Policy Manual (PIN )

20. Program Updates (Continued)
Focus on implementation and quality
Creation of policies and procedures
Implementation of policies and procedures
Reevaluation of policies and procedures
Technical Assistance and Education

21. Future Plans FTCA Deeming PIN Clarification of Requirements Focus
QI/QA,
Application process expectations
Risk Management
Credentialing
Medical Records

22. Future Plans (continued)
QI/QA PIN
Clarify and articulate the standards for:
QI/QA Program and Committee roles and responsibilities
QI/QA Plan
Leadership Roles in QI/QA oversight
Risk Management Program
Medical Records

23. FTCA Site Visits FTCA Site Visits
Focuses specifically on FTCA requirements
Conducted by
FTCA Staff
MSCG Contractors
Regional Staff
Collaboration with project officers

24. FTCA Site Visits Types of Visits Verification of Implementation
Technical Assistance and Education
Claims and Liability Issues

25. FTCA by the Dollars
FTCA represents a significant savings for Health Centers
Significant money spent on claims
Increased focus on quality and risk management

26. 2011 – Top 5 incidents by Type 190 Claims filed in 2011
Diagnosis and treatment - related incidents lead to largest amount of claims
Closely followed by Obstetrics- related incidents

27. CY 2013 FTCA Deeming

28. Types of Applications
There are two types of applications for FTCA coverage:
EHB System was opened to receive applications on February 23, 2012
INITIAL DEEMING APPLICATION
May be submitted at any time during the year when the EHB system is open to receive applications.
Will be acted upon by HRSA within 30 days after receipt of a completed application
ANNUAL REDEEMING APPLICATION
All currently deemed health centers must file a renewal deeming application to be deemed for CY This year’s deadline was April 5, 2012

29. CY 2013 Requirement Updates
Minutes from any six QI/QA committee meetings. All minutes must be dated between June 1, 2011 and the submission date of the application.
Remove patient names and other identifiers
Minutes from any six Board meetings that reflect Board approval of QI/QA activities. All minutes must be dated between June 1, 2011 and the submission date of the application.
Remove all information not related to QI/QA activity

30. CY 2013 Requirement Updates (continued)
Board-approved Credentialing and Privileging (C&P) policies
Must be signed and dated by the Board
(C&P) Plan + Page with Board of Directors Signature
(C&P) Plan + Signed Board Minutes showing C&P plan was approved
Clinical policies and procedures for the following activities:
Referral Tracking
Hospitalization Tracking
Diagnostic Tracking (Should include X-Ray Tracking Lab Result Tracking)

31. Requirements A complete initial or redeeming application must include:
An Application Form completed in EHB
An approved Quality Improvement/Quality Assurance Plan, including governing board signature and approval date
Two Methods to demonstrate Board approval
QI/QA Plan + Page with Board of Directors Signature
QI/QA Plan + Signed Board Minutes showing QI/QA plan was approved

32. Requirements
Summary of professional liability history for cases filed or closed within the last 5 years, if applicable
Name of provider(s) involved
Area of practice/Specialty
Date of Occurrence
Summary of allegations
Status and outcome of claim

33. Requirements (continued)
Explanation of any “NO” responses
Deeming applications for any sub-recipients (as documented on the organization’s most recent approved scope from FORM 5B - see “sub-recipient submission instructions.”)

34. Requirements (continued)
Credentialing list (in an excel spreadsheet) of all licensed and/or certified health care personnel employed and/or contracted by the health center, with the following information:
Name & Professional Designation (e.g., MD/DO, RN, CNM, DDS)
Title/Position
Specialty
Employment Status (full-time employee, part-time employee, contractor, volunteer)
Date of Hire
Current Credentialing Date
Next Expected Credentialing Date
** Please note that for the 2012 application “Initial Credentialing Date (the first time the individual was credentialed by your organization)” has been removed and is no longer required.

35. TECHNICAL ASSISTANCE AND RESOURCES

36. FTCA WEBSITE http://www.bphc.hrsa.gov/ftca/

37. CY 2013 FTCA Application Technical Assistance (TA) Videos
Online Instructional Videos
Step by step instructional videos that demonstrate how to fill each section of the FTCA application and general EHB guidance.
Supplemental videos that reviews best practices and points out resources that are useful in developing policies and procedures that are connected to the FTCA Deeming process.
Currently Available on the ECRI website at the following link: :

38. Quality Improvement Resources
HRSA Quality Improvement Webinars:
ECRI Resource Page: Quality Improvement:

39. Risk Management Resources
Tracking Tool Kit
Credentialing Tool Kit
Credentialing Webinar Archived

40. Risk Management Resources
Risk Management Plan:
Event Reporting Toolkit:
Webinars
Clinical Risk Management Basics Part I
Developing a Risk Management Plan

41. Risk Management Resources
Sample Risk Management Policy: Physician Office Practice
Patient Satisfaction Questionnaire
Anecdotal Note for Patient Concerns
Handling Patient Complaints
Safety Attitudes Questionnaire (Ambulatory Version)

42. FTCA Website: http://www.bphc.hrsa.gov/ftca/
Office Contact
FTCA/BPHC Help Line
Phone: BPHC ( )
9:00 AM to 5:30 PM (ET)
FTCA Website:

43. Contact
Christopher W. Gibbs, JD, MPH 5600 Fishers Lane Rockville, Maryland