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

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

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.

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).

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.

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)].

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

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.

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.

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).

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 2011-01). 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).

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.

Non-Health Center Patients Federal Register Notice September 25, 1995 (Volume 60 Number 185) page 49417 – 49418. 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 2011-01. Application Information for PDs is located on page 9 and 10

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

FTCA CLAIMS PROCESS

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.

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 gcgl@hhs.gov 202-233-0233 202-233-0227 (fax) Have health center attorney request extension of time to reply.

FTCA PROGRAM UPDATES

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 2011-01) http://bphc.hrsa.gov/policiesregulations/policies/pdfs/pin201101manual.pdf

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

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

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

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

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

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

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

CY 2013 FTCA Deeming

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 2013. This year’s deadline was April 5, 2012

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

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)

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

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

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.”)

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.

TECHNICAL ASSISTANCE AND RESOURCES

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

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: : https://members2.ecri.org/Components/HRSA/Pages/Videos_Deeming.aspx

Quality Improvement Resources HRSA Quality Improvement Webinars: http://bphc.hrsa.gov/policiesregulations/quality/ ECRI Resource Page: Quality Improvement: https://members2.ecri.org/Components/HRSA/Pages/QI.aspx

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

Risk Management Resources Risk Management Plan: https://members2.ecri.org/Components/HRSA/Pages/RMPlan.aspx Event Reporting Toolkit: https://members2.ecri.org/Components/HRSA/Pages/EventReportToolkit.aspx Webinars https://members2.ecri.org/Components/HRSA/Pages/Webinar_Audioconf_Archive.aspx: Clinical Risk Management Basics Part I Developing a Risk Management Plan

Risk Management Resources Sample Risk Management Policy: Physician Office Practice https://members2.ecri.org/Components/HRSA/Pages/PSRMPol3.aspx Patient Satisfaction Questionnaire https://members2.ecri.org/Components/HRSA/Pages/PSRMPol2.aspx Anecdotal Note for Patient Concerns https://members2.ecri.org/Components/HRSA/Pages/OAPol4.aspx Handling Patient Complaints https://members2.ecri.org/Components/HRSA/Pages/OAPol3.aspx Safety Attitudes Questionnaire (Ambulatory Version) https://members2.ecri.org/Components/HRSA/Pages/PSRMPol1.aspx

FTCA Website: http://www.bphc.hrsa.gov/ftca/ Office Contact FTCA/BPHC Help Line Phone: 1-877-974-BPHC (877-974-2742) 9:00 AM to 5:30 PM (ET) Email: BPHChelpline@hrsa.gov FTCA Website: http://www.bphc.hrsa.gov/ftca/

Contact Christopher W. Gibbs, JD, MPH 5600 Fishers Lane Rockville, Maryland 20857 Cgibbs@hrsa.gov 301-594-0818