Martin J. Bree Senior Partner Triton Group, LLC. FTCA Update/Lessons Learned 12th Annual 2005 Region IX Management Training Conference Burbank, California September 27, 2005 Martin J. Bree Senior Partner Triton Group, LLC. September 19, 2018

Triton Group First Source of FTCA Program Information Triton Group 227 Hamburg. Pompton Lakes, NJ 07442 HRSA Contract No. 232-00-0097 Roger Fuydal 866-FTCA-HELP - Toll Free (866-382-2435) Marty Hiller (Free Clinics) 973-831-8395 (Fax) 216-382-4150 tritongp@optonline.net mhiller862@hotmail.com Martin J. Bree 215-861-4373 215-861-4391 (fax) 856-625-8638 (cell) mbree@hrsa.gov. September 19, 2018

Today’s workshop will cover: Medical Malpractice 2005 How the Program Works for Health Centers Limitations of Coverage Credentialing and Privileging Program Value Claim Status Risk Management HIPAA Section 194 Questions September 19, 2018

Medical Malpractice 2005 Med Mal premiums increase 40% 2002-2003 37% 2003-2004 Average Indemnity Payments (per PIAA) 1996 - $196,392 1997 - $223,167 1998 - $232,178 1999 - $253,479 2000 - $285,354 2001 - $295,610 2002 - $309,381 2003 – $328,757 September 19, 2018

Medical Malpractice 2005 (cont.) Increased premiums particularly affect: Radiology Obstetrics/gynecology Neurosurgery Emergency Medicine The percentage of indemnity payments over $1 million has doubled since 1997 reaching 2.9% in 2003 Med Mal losses have been increasing 19 times faster than other tort losses (AIG) September 19, 2018

Medical Malpractice 2005 Obstetrics Claims Most paid claims of any specialty – 36% of closed claims result in payment Highest % of paid claims over $1 million – 27% Average indemnity for 2001 – 2003 was $440,658 Neurologically impaired newborns second most prevalent medical condition resulting in a claim after breast cancer September 19, 2018

Medical Malpractice 2005 (cont.) General and Family Practice for 2001 - 2003 27% of closed claims result in payment Average indemnity $276,171 Internal Medicine for 2001 - 2003 25% of closed claims result in payment Average indemnity $307,024 Pediatrics for 2001 – 2003 31% of closed claims result in payment Average indemnity $389,658 September 19, 2018

Medical Malpractice 2005 (cont.) Proposed solutions Caps on non-economic damages Limitations on venue shopping Requiring “Certificates of Merit” Better underwriting September 19, 2018

How the Program Works for Health Centers A scheme that provides immunity from lawsuit. Appears similar to an occurrence malpractice policy. Program in existence for 13 years. Very successful in terms of savings for health centers and coverage of health centers and staff. September 19, 2018

How the Program Works for Health Centers (cont.) 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). September 19, 2018

How the Program Works for Health Centers (cont.) 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. September 19, 2018

How the Program Works for Health Centers (cont.) 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)]. School-based Health Centers [Section 330]. September 19, 2018

How the Program Works for Health Centers (cont.) Who is covered - people Employees. Officers. Directors. Governing board members. Contractors (some, not all). September 19, 2018

How the Program Works for Health Centers (cont.) Who is covered - Employees All employees, full time or part time. Volunteers are not employees. Employees get a W-2 at end of year. September 19, 2018

How the Program Works for Health Centers (cont.) 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. September 19, 2018

How the Program Works for Health Centers (cont.) Contractors 42 U.S.C. §233(g)(1)(A) “…any contractor of such an entity who is a physician, or other licensed or certified health care practitioner”. 42 U.S.C. §233 (g)(5) “an individual may be considered a contractor”. El Rio Case September 19, 2018

How the Program Works for Health Centers (cont.) What is covered? Medical malpractice. More specifically, medical, surgical, dental and related activities (if within the scope of employment and scope of project). September 19, 2018

How the Program Works for Health Centers (cont.) 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 2002 - 07). 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 cannot be changed in a grant application. There is a separate process. A grant award for a new section 330 activity does change the Scope of Project. September 19, 2018

How the Program Works for Health Centers (cont.) When is it covered Coverage is only for acts that are within the scope of employment of the covered individual No Moonlighting Acting on behalf of the deemed entity September 19, 2018

How the Program Works for Health Centers (cont.) 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. September 19, 2018

How the Program Works for Health Centers (cont.) Procedure Plaintiffs often file suit in state court. What to do: Immediately fax complaint and deeming letter to: Lisa Barsoomian Department of Health and Human Service Office of General Counsel (OGC) 202-619-2922 (Fax) 202-619-2155 (Voice) Have health center attorney request extension of time to reply. September 19, 2018

How the Program Works for Health Centers (cont.) Touhy Regulation Medical Malpractice cases only! Affects deemed health centers only. Requests for testimony where the United States, the health center or its providers are not a party. Health center provider must have permission of HRSA administrator to testify. September 19, 2018

How the Program Works for Health Centers (cont.) Touhy Regulation Policy Information Notice 2001-19. Submit request for deposition or testimony to DHHS/OGC (fax to 202-619-2922). HRSA Administrator will approve or deny. If approved representation may be provided by DOJ. September 19, 2018

How the Program Works for Health Centers (cont.) – Potential Problems Contracts. Sub-Recipients. Scope of Project. Billing Arrangements. Americans with Disabilities Act, Rehabilitation Act, Civil Rights Act. September 19, 2018

How the Program Works for Health Centers (cont.) Important Issues Non-health center patients – a potential problem. Insurance requirements of hospitals and Health Maintenance Organizations. National Practitioner Data Bank. Deeming Renewal . Credentialing – a critical issue. September 19, 2018

Non-Health Center Patients Federal Register Notice September 25, 1995 (Volume 60 Number 185) page 49417 – 49418. Hospital On-Call Requirements. Cross Coverage Arrangements. Community Activities. Other situations require a “Particularized Determination” See 99-08. September 19, 2018

Insurance Requirements of Hospitals and HMO’s. 42 U.S.C. §233(j) - Remedy for denial of admitting privileges to certain health care providers. 42 U.S.C. §233(m) - Application of coverage to managed care plans. September 19, 2018

National Practitioner Data Bank (NPDB) HRSA Participates in the NPDB. 42 U.S.C. §401 – 431. Assistant Secretary of Health elects to require PHS agencies to report – October 1987. http://www.npdb-hipdb.com. September 19, 2018

Other Insurance Gap or Wrap-around: covers medical malpractice not covered by FTCA. Volunteers Outside Scope Contracts with corporations Contracts with part time specialists Tail Insurance General Liability Insurance Directors and Officers Liability Proof of malpractice coverage – Triton Group September 19, 2018

Deming Applications New organizations (never deemed before): Submit application found in PIN 99-08 to BPHC (currently Susan Lewis in Philadelphia). Deemed entities at end of project period (competing continuations): Deemed entities at end of budget period (non-competing continuations): Application is part of single grant application. September 19, 2018

Program Value Malpractice Premium Savings Study conducted by Princeton Insurance Company. Premiums calculated for 2002 Used Uniform Data System (UDS) data for deemed Health Centers September 19, 2018

Program Value Malpractice Premium Savings Study Methodology Used Occurrence Premiums with $1m/3m limits. Premiums include 25% for taxes, profits, commissions, etc. Each deemed Health Center rated by its specific territory. Rates based on Full Time Equivalents by specialty. Premium increased by 10% to cover corporation and allied personnel. September 19, 2018

Program Value Malpractice Premium Savings Study Results 2002 Savings for deemed centers - $164,000,000 Extrapolating from 2002 and 1999 studies: total savings since 1993 $1 billion September 19, 2018

Claim Status - National Oct. 1994 thru Dec. 2004 - 1546 Claims filed against the United States. Closed Claims - approximately 55% of total. Paid Claims – approximately 30% of closed claims. Avg. cost per paid claim - $370,000.* Avg. cost per closed claim - $114,000* September 19, 2018

Health Center Claims per Month September 19, 2018

Health Center Loses per Year September 19, 2018

National Health Center Data September 19, 2018

National Health Center Data Frequency of Adverse Outcome by Region 20 40 60 80 100 120 140 160 180 200 220 240 Death Loss of/damage to organ Exacerbation of disease/condition Loss of/damage to limb Brain damage Skin/tissue/muscle injury Fetal death Other nerve damage Delay in recovery Emotional only Infection Reduced life expectancy Skeletal injury Loss/damage to tooth/dental prosthes Blindness/Ophthalmic injury All Others Combined Adverse Outcome # of Claims (Frequency) Region 01 Region 02 Region 03 Region 04 Region 05 Region 06 Region 07 Region 08 Region 09 Region 10 September 19, 2018

National Health Center Data Frequency of Specialty by Region 30 60 90 120 150 OBSTETRICS-GYNECOLOGY FAMILY PHYSICIANS (PRACTICE) INTERNAL MEDICINE-MINOR SURGERY DENTISTS PEDIATRICS OTHER SPECIALISTS GENERAL PRACTITIONERS SPECIALTY NOT IDENTIFIED GENERAL SURGERY Physician Specialty # of Claims (Frequency) Region 01 Region 02 Region 03 Region 04 Region 05 Region 06 Region 07 Region 08 Region 09 Region 10 September 19, 2018

Health Center National Data September 19, 2018

Health Center National Data September 19, 2018

Health Center National Data September 19, 2018

Health Center National Data September 19, 2018

Health Center National Data September 19, 2018

Health Center National Data September 19, 2018

Risk Management Health Centers are expected to use a portion of savings to provide risk management services. (PIN 99-08 Para. XVIII). NACHC – Risk Management Technical Assistance line – 517-703-8464. Inspector General report on risk management in health centers. Triton Group – can assist you in finding appropriate risk management services – 866-FTCA-HELP. September 19, 2018

Risk Management Credentialing and Privileging Medical Records Informed Consent Birth Injuries Tracking Systems September 19, 2018

Credentialing and Privileging PIN 2002-22 Credentialing and privileging required of all licensed or certified health care practitioners. Process for Licensed Independent Practitioners (LIPs) generally mimics JCAHO. Non-LIPs requires primary source verification of only license or certification. Volunteers included. September 19, 2018

Credentialing and Privileging Verification of the education, training, and experience of provider. Privileging “The process of authorizing a licensed or certified health care practitioners specific scope and content of patient care services” or Assessment of the clinical competence of the provider to do the job expected.. September 19, 2018

Medical Records Legibility Completeness Organization Permanent archive of patient’s treatment. Communication tool between providers. Legal defense tool. Completeness More is better than less. Organization Chronological. Dividers. Medication summary sheets/problem lists. September 19, 2018

Medical Records Security Signatures Storage. Correction. Release of information. Signatures September 19, 2018

Informed Consent Your don’t “give” informed consent. You “get” informed consent. It is a communication process, not a form that the patient signs. Components Competency. Information. Written (in appropriate language). September 19, 2018

Birth Injuries Biggest component of losses under Health Center FTCA program. Utilize protocols. Shoulder Dystocia Drills. Clinical competencies. VBACs? September 19, 2018

Tracking Systems For all tests? Why not. Electronic vs. manual. System should be redundant. QI testing of systems. How do we track referrals? Telephone calls. September 19, 2018

HIPAA Section 194 Volunteers in Free Clinics Provides Med Mal protection to “Volunteers in “Free Clinics” Volunteer and free clinic are specifically defined in the statute Does not cover the free clinic corporation nor the free clinic employed staff Free clinic may not accept any third party reimbursement Must give notice to patients on limitations of liability September 19, 2018

Federal Staff Aida Stark, FTCA Program Director Susan Lewis 301-594-4442 aida.stark@hrsa.hhs.gov Susan Lewis 215-861-4373 215-861-4391 (fax) slewis@hrsa.gov September 19, 2018

FTCA HELP Triton Group Martin J. Bree Roger Fuydal 215-861-4373 215-861-4391 (fax) mbree@hrsa.gov Roger Fuydal 866-FTCA-HELP (toll free) 866-382-2435 Tritongp@optonline.net 227 Hamburg Tpke. Pompton Lakes, NJ 07442 September 19, 2018