FTCA MEDICAL MALPRACTICE BASICS AND PROGRAM UPDATES

Christopher W. Gibbs, JD, MPH

Department of Health and Human ServicesHealth Resources and Services Administration

Bureau of Primary Health CareOffice 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:

o Community Health Centers [section 330 (e)]. o Migrant Health Centers [section 330 (g)].o Health Care for the Homeless [section 330 (h)].o 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

• Procedure– 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).o 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)

o Have health center attorney request extension of time to reply.

FTCA PROGRAM UPDATES

Program Updates

• FTCA Branch– Branch within OQD– 6 staff members

o 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

o QI/QA,o Application process expectations o Risk Management o Credentialingo Medical Records

Future Plans(continued)

• QI/QA PIN– Clarify and articulate the standards for:

o QI/QA Program and Committee roles and responsibilities

o QI/QA Plano Leadership Roles in QI/QA oversighto Risk Management Program o Medical Records

FTCA Site Visits

• FTCA Site Visits– Focuses specifically on FTCA requirements– Conducted by

o FTCA Staffo MSCG Contractors o Regional Staffo Collaboration with project officers

FTCA Site Visits

– Types of Visitso Verification of Implementationo Technical Assistance and Educationo Claims and Liability Issues

• FTCA represents a significant savings for Health Centers

• Significant money spent on claims

• Increased focus on quality and risk management

FTCA by the Dollars

FY 2007 FY 2008 FY 2009 FY 2010$0

$50

$100

$150

$200

$250

$192 $204 $204 $209

$37.90

$61.20

$45.50 $52.94

Prem Svings (Mil)

FTCA Premium Savings and Paid Claims in Millions

$Mill

ion

s

Year

• 190 Claims filed in 2011

• Diagnosis and treatment -related incidents lead to largest amount of claims

• Closely followed by Obstetrics- related incidents

2011 – Top 5 incidents by Type

Total Incidents

Diagnosis Related

Obstetrics Related

Treatment Related

Surgery Re-lated

Medication Related

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

o May be submitted at any time during the year when the EHB system is open to receive applications.

o Will be acted upon by HRSA within 30 days after receipt of a completed application

– ANNUAL REDEEMING APPLICATIONo 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:1. An Application Form completed in EHB2. An approved Quality Improvement/Quality Assurance

Plan, including governing board signature and approval date

1. 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

3. Summary of professional liability history for cases filed or closed within the last 5 years, if applicable

Name of provider(s) involvedArea of practice/SpecialtyDate of OccurrenceSummary of allegationsStatus and outcome of claim

Requirements (continued)

4. Explanation of any “NO” responses5. 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)

6. 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:o Name & Professional Designation (e.g., MD/DO, RN, CNM,

DDS)o Title/Positiono Specialtyo Employment Status (full-time employee, part-time employee,

contractor, volunteer)o Date of Hireo Current Credentialing Dateo 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

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