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

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

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

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. 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 NACHC Copyright – July 2014

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

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

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

Malpractice, Federal Tort Claims Act and Risk Management 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: 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

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) 2001-16, 2002-22, 2011-01 (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

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

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

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

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

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

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) 2008-01 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

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 1992. 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

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

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

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

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

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

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

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

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

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

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 2001-16 Credentialing and Privileging PIN 2002-22 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

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

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

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

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) 2008-01 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

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

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

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

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

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) 691-2369 Fax: (202) 619-2922 E-mail: HHS-FTCA-Claims@hhs.gov This slide had to be prepared by a lawyer—it’s too cliché, but also thorough and accurate. NACHC Copyright - February 2016

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

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

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

NACHC Risk Management Resources Malpractice, Federal Tort Claims Act and Risk Management 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/ 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

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

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

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 (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 NACHC Copyright - February 2016

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

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 2001-16: Credentialing and Privileging of Health Center Practitioners http://bphc.hrsa.gov/programrequirements/pdf/pin200116.pdf PIN 2002-22: Clarification of Credentialing and Privileging Outlined in PIN 2001-16 http://bphc.hrsa.gov/programrequirements/pdf/pin200222.pdf NACHC Copyright - February 2016

Additional Resources (cont’d) Malpractice, Federal Tort Claims Act and Risk Management Additional Resources (cont’d) PIN 2008-01: Defining Scope of Project and Policy for Requesting Changes http://bphc.hrsa.gov/programrequirements/pdf/pin2008-01.pdf PAL 2016-03: Calendar Year 2017 Requirements for Federal Tort Claims Act (FTCA) Coverage for Health Centers http://bphc.hrsa.gov/programrequirements/pdf/pal201603.pdf NACHC Copyright - February 2016