1. Malpractice, Federal tOrT Claims Act (FTCA) and risk management
Malpractice, Federal Tort Claims Act and Risk Management
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.
NACHC Copyright - February 2016

2. Federal Tort Claims Act (FTCA): Background
Malpractice, Federal Tort Claims Act and Risk Management
Federal Tort Claims Act (FTCA): Background
History of Medical Malpractice Coverage
Commercial insurance
Malpractice crisis of 1980s
Return of commercial market in 1990s
“Hardened market” in 2000
State by state crisis 2003 2
NACHC Copyright – July 2014

3. FTCA Background (cont'd)
Malpractice, Federal Tort Claims Act and Risk Management
FTCA Background (cont'd)
Traditional Malpractice Insurance
“Claims Made”
“Occurrence”
“Tail Coverage”
“Nose Coverage”
“Gap Coverage”
Limits of tail coverage by time 3
NACHC Copyright – July 2014

4. Malpractice, Federal Tort Claims Act and Risk Management
FTCA: History
FTCA creates tort liability for actions of employees of U.S.
1992 Federally Supported Health Centers Assistance Act (P.L ) extended FTCA coverage to section 330 grantees who submit an FTCA application and meet statutory requirements
1995 FSHCAA (P.L ) made FTCA coverage permanent and clarified coverage 4
NACHC Copyright – July 2014

5. Malpractice, Federal Tort Claims Act and Risk Management
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
NACHC Copyright – July 2014

6. Malpractice, Federal Tort Claims Act and Risk Management
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?
Testifying to the accuracy when signing (CEO) 6
NACHC Copyright – July 2014

7. Malpractice, Federal Tort Claims Act and Risk Management
FTCA: Deeming
Eligible Entities (330 funded)
Migrant Health Centers
Community Health Centers
Health Care for the Homeless Programs
Health Services in Public Housing
School-Based Health Centers 7
NACHC Copyright – July 2014

8. Malpractice, Federal Tort Claims Act and Risk Management
FTCA: Deeming (cont'd)
“The Health Center Program: Policy Information Notice : Updated Federal Tort Claims Act (FTCA) Health Center Policy Manual”
“The Health Center Program: Program Assistance Letter (PAL) : Calendar Year 2017 Requirements for Federal Tort Claims Act (FTCA) Medical Malpractice Coverage for Health Centers
Ineligible Entities:
Federally Qualified Health Center (FQHC) ‘Look-Alikes’
There may changes coming from Draft Compliance Manual, Keep your eyes peeled and make comment
supercedes 8
NACHC Copyright – July 2014

9. Malpractice, Federal Tort Claims Act and Risk Management
FTCA: Deeming (cont'd)
Requirements:
Credentialing and privileging of all licensed or certified health care providers
See Bureau of Primary Health Care (BPHC) Policy Information Notices (PINS) , , (This Policy is applicable to all health centers deemed or not).
Applies to all health center practitioners (employed or contracted), volunteers (not covered), contractors and locum tenens
Querying National Practitioner Data Bank (NPDB)
Continuous query program 9
NACHC Copyright – July 2014

10. FTCA: Deeming Applications
Malpractice, Federal Tort Claims Act and Risk Management
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
NACHC Copyright – July 2014

11. FTCA: Deeming Requirements (cont’d)
Malpractice, Federal Tort Claims Act and Risk Management
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 2Y
Policies and procedures for 1) referrals tracking; 2) hospitalization tracking; and 3) diagnostic (x-ray & lab) tracking;
Self assessment list for qi/qa minutes for key touch points for credentilas, privileges, sie visits 11
NACHC Copyright – July 2014

12. Malpractice, Federal Tort Claims Act and Risk Management
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
NACHC Copyright – July 2014

13. FTCA: Who Is Not Covered?
Malpractice, Federal Tort Claims Act and Risk Management
FTCA: Who Is Not Covered?
Volunteers – note: the 21st 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
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
“Not Covered”—big topic. This will go on. Point out that even though these groups are not covered, they still need to be credentialed and privileged. You must know who is in your center and what you privileged them to do, even if they are responsible for their own malpractice insurance. Not a bad idea—just a bit confusing. Try to find simple ways to credential and privilege students.
NACHC Copyright - February 2016

14. FTCA: Who Is Not Covered? (cont'd)
Malpractice, Federal Tort Claims Act and Risk Management
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*
“Not Covered” continued. Point out that many have tried to get on the FTCA band wagon; this list tries to define the limits of FTCA.
*A sub-grantee can apply to be deemed through its grantee and therefore have FTCA coverage
NACHC Copyright - February 2016

15. Malpractice, Federal Tort Claims Act and Risk Management
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
See Bureau of Primary Health Care (BPHC) Policy Information Notice (PIN)
Activities within scope of employment or health center duties
Two key concepts come out here. Look carefully at scope of project/employment agreement. In other words, create a paper trail which makes it clear that clinical activity falls within the FTCA umbrella. For unusual activities, a particularized determination might be necessary (see following).
NACHC Copyright - February 2016

16. FTCA: What Is Covered? (cont'd)
Malpractice, Federal Tort Claims Act and Risk Management
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
Covered services to non-health center patients were a question in If the activity is required by scope of practice or employment agreement/job description—it’s covered. An easy example is if the organization requires, via job description, that practitioners need to have hospital privileges and the hospital requires “no doc” ER coverage for privileges—thus, the ER patient (even though not a health center patient) is covered. There are innumerable variations on this theme.
NACHC Copyright - February 2016

17. FTCA: What Is Covered? (cont'd)
Malpractice, Federal Tort Claims Act and Risk Management
FTCA: What Is Covered? (cont'd)
Covered Non-Health Center Patients
Participants in screening or health fairs (if this is in your scope on form 5c)
After hours patients you see for a cross-covering practice (if you are required to see them by hospital policy and your employment contract)
Unassigned ED patients (if you are required to see them by hospital policy and your employment contract)
It is critical to mention that this coverage only applies AFTER HOURS. Recent request for specialized determination has (verbal report only so far) found that one is not covered for CHC Providers caring for non-health center patients when the coverage does not occur after hours!
NACHC Copyright - February 2016

18. FTCA: Other Provisions
Malpractice, Federal Tort Claims Act and Risk Management
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
Miscellaneous. Why would the Bureau pay for dual coverage? Gap ok. Others must accept as coverage (1995 law). Provider may buy their own but government may subjugate the costs.
NACHC Copyright - February 2016

19. Malpractice, Federal Tort Claims Act and Risk Management
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?
Group 1. You are interviewing a potential provider who has heard about this odd insurance at health centers, who would like to know what it is all about. What can you teach them in 5-10 minutes?
Include:
Federal court with judge vs state court with jury
Not an area of expertise for most med/mal attorneys
No tail
Medical review panel
NACHC Copyright - February 2016

20. Malpractice, Federal Tort Claims Act and Risk Management
Recruiting
Advantages for a prospective provider
Provides immunity from lawsuit
No tail
Occurrence coverage
Part time work is possible
Medical Claims Review Panel 20
NACHC Copyright - February 2016

21. Malpractice, Federal Tort Claims Act and Risk Management
FTCA: Implementation
Advantages to Health Centers
No cost to individual centers (No direct cost)
No dollar limit on liability
Decreases “frivolous” lawsuits
Health and Human Services (HHS) Review the claims that are filed before a lawsuit is permitted
Plaintiff’s attorneys prefer Jury vs. Federal Judge
The advantages are many. For health centers and health center docs, it’s nice to stay within the limit. The federal process continues to defer some law suits—but not all.
NACHC Copyright - February 2016

22. Medical Claims Review Panel
Malpractice, Federal Tort Claims Act and Risk Management
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
NACHC Copyright - February 2016

23. FTCA: Implementation (cont'd)
Malpractice, Federal Tort Claims Act and Risk Management
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
“Concerns” usually means places where we’ve screwed up. Judgments are related to time and the number of participants. However, savings grow when judgments grow.
NACHC Copyright - February 2016

24. Malpractice, Federal Tort Claims Act and Risk Management
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?
Group #3 So the practitioner takes the job, how do you credential them?
NACHC Copyright - February 2016

25. Malpractice, Federal Tort Claims Act and Risk Management
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
NACHC Copyright - February 2016

26. FTCA: Implementation (cont'd)
Malpractice, Federal Tort Claims Act and Risk Management
FTCA: Implementation (cont'd)
Credentialing and Privileging
A “critical issue” for health centers
Directly impacts the FTCA program
BPHC Guidance
Definitions
“Credentialing” – Who they are
“Privileging” – What they can do
Credentialing & Privileging PIN
Credentialing and Privileging PIN
Credentialing and Privileging. In the KISS (Keep It Simple Stupid) mode (my best mode), credentialing lets you know who the provider is and what training they have. Privileging tells them what they can do in your centers. Note that credentialing is universal/constant; i.e., once you’ve verified the medical school, it’s done. Privileging is more fluid and site-specific. One may be able to do hernia repairs in the hospital—but, not in your clinic. Thus the need to do your own privileging. In fact, there may be multi-site organizations where it would be appropriate, based on staff and facilities, to do a procedure in one site (e.g. circumcisions), but not in others.
NACHC Copyright - February 2016

27. FTCA: Implementation (cont'd)
Malpractice, Federal Tort Claims Act and Risk Management
FTCA: Implementation (cont'd)
Credentialing and Privileging (cont'd)
Definitions (cont'd)
Organizational “leaders”
Credentialing and privileging authority
Licensed Independent Practitioners (LIPs)
Other licensed or certified practitioners
Primary source verification
Note that LIPs require primary source verification and other licensed or certified, secondary. For details, see the PIN/JC standards or others.
May no longer need to primary source if state licensing board does so.
NACHC Copyright - February 2016

28. FTCA: Implementation (cont'd)
Malpractice, Federal Tort Claims Act and Risk Management
FTCA: Implementation (cont'd)
Credentialing and Privileging (cont'd)
E-Credentials
An Effective Program
Highly structured
Formal
Timely
Re-privileging process
Denials and appeals process
Provider involvement and education
Don’t forget re-privileging (usually every 2 years) and appeals processes.
NACHC Copyright - February 2016

29. Malpractice, Federal Tort Claims Act and Risk Management
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?
NACHC Copyright - February 2016

30. Malpractice, Federal Tort Claims Act and Risk Management
FTCA: Scope Of Project
Covers only incidents that occur within the scope of project
See Bureau of Primary Health Care (BPHC) Policy Information Notice (PIN)
Scope of project refers to activities described in the grant application that was approved via notice of grant award
Includes any changes in scope of project approved after the original notice of grant award.
Sites and services are key elements of scope of project
Summarized in EHB Forms 5A,B, & C.
This is a clear definition of scope: activities described in an application and approved. Point out that any changes must be approved before care is delivered. Both the same service at a new site and a new service at the same site require approval.
NACHC Copyright - February 2016

31. FTCA: Scope of Project (cont'd)
Malpractice, Federal Tort Claims Act and Risk Management
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!
Regulations regarding scope changes are constantly in flux. Pay attention.
Working on a new easier change of scope process
NACHC Copyright - February 2016

32. Malpractice, Federal Tort Claims Act and Risk Management
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?
NACHC Copyright - February 2016

33. Touhy Regulation (cont’d)
Malpractice, Federal Tort Claims Act and Risk Management
Touhy Regulation (cont’d)
10/11/2017
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
“Information acquired in the course of performing official duties or because of the person's official capacity”, FTCA Policy Manual
This slide had to be prepared by a lawyer—it’s too cliché, but also thorough and accurate.
NACHC Copyright - February 2016

34. Touhy Regulation (cont’d)
Malpractice, Federal Tort Claims Act and Risk Management
Touhy Regulation (cont’d)
10/11/2017
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
NACHC Copyright - February 2016

35. Touhy Regulation (cont’d)
Malpractice, Federal Tort Claims Act and Risk Management
Touhy Regulation (cont’d)
10/11/2017
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:
DHHS Office of the General Counsel (OGC) General Law Division (GLD)
Phone: (202)
Fax: (202)
This slide had to be prepared by a lawyer—it’s too cliché, but also thorough and accurate.
NACHC Copyright - February 2016

36. Malpractice, Federal Tort Claims Act and Risk Management
A provider calls you after a patient has an unexpectedly bad outcome. What steps should you take with:
The medical record?
Your attorney?
Risk management?
Quality improvement?
NACHC Copyright - February 2016

37. Risk Management (cont’d)
Malpractice, Federal Tort Claims Act and Risk Management
Risk Management (cont’d)
Areas of Importance
Quality Management
Credentialing and Privileging
Clinical Management
Patient Records
Patient Communications
Incident Tracking and Reporting
RM links patient safety and the malpractice coverage under FTCA. Risk management is both a program expectation for CHCs and a requirement for CHC accreditation.
NACHC Copyright - February 2016

38. Risk Management (cont'd)
Malpractice, Federal Tort Claims Act and Risk Management
Risk Management (cont'd)
Risk Concern Areas
Use of protocols
Medical record documentation
Credentialing and privileging
Referral issues
OB/GYN, procedures, failure to diagnose
Concerns, again. These are the places we have had suits that cost us money.
NACHC Copyright - February 2016

39. NACHC Risk Management Resources
Malpractice, Federal Tort Claims Act and Risk Management
NACHC Risk Management Resources
Clinical Issues/Risk Management
ECRI Institute
Health Center Compliance.com
Emergency Care Research Institute = (ECRI). 2009—ECRI Institute Patient Safety Organization (PSO) has been designated by the U.S. Department of Health and Human Services as a federal Patient Safety Organization (PSO) under the Patient Safety and Quality Improvement Act of 2005.
Page 21 of the Manual has a How to Respond list.
NACHC Copyright - February 2016

40. Malpractice, Federal Tort Claims Act and Risk Management
FTCA: Final Words
FTCA and solid Risk Management is
A Winning Partnership
An Effective Risk Management Program is:
Structured
Comprehensive
Organization-wide
Leader supported
Legally sound
“Top of Mind”
This slide had to be prepared by a lawyer—it’s too cliché, but also thorough and accurate. NO FORMULA
NACHC Copyright - February 2016

41. Malpractice, Federal Tort Claims Act and Risk Management
Key Link
HRSA – FTCA for Health Centers: Key Resources in Supporting Quality Care
FTCA Policies
Application Process
Particularized Determination
Health Center Claims
FTCA for Health Center FAQs
Risk Management Resources
NACHC Copyright - February 2016

42. History of Health Centers and National Health Service Corps
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 (
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
NACHC Copyright - February 2016

43. Malpractice, Federal Tort Claims Act and Risk Management
Additional Resources
National Practitioner Data Bank (NPDB)
HRSA FTCA Health Center Policy Manual
Health Center Compliance.com
NACHC Copyright - February 2016

44. Additional Resources (cont’d)
Malpractice, Federal Tort Claims Act and Risk Management
Additional Resources (cont’d)
Bureau of Primary Health Care (BPHC) Policy Information Notices (PINs) & Program Assistance Letters (PALs)
PIN : Credentialing and Privileging of Health Center Practitioners
PIN : Clarification of Credentialing and Privileging Outlined in PIN
NACHC Copyright - February 2016

45. Additional Resources (cont’d)
Malpractice, Federal Tort Claims Act and Risk Management
Additional Resources (cont’d)
PIN : Defining Scope of Project and Policy for Requesting Changes
PAL : Calendar Year 2017 Requirements for Federal Tort Claims Act (FTCA) Coverage for Health Centers
NACHC Copyright - February 2016