FTCA MEDICAL MALPRACTICE BASICS AND PROGRAM UPDATES & UDS Clinical Measures Christopher W. Gibbs, JD, MPH Heather Ngai, MPH Charles A. Daly, MHA Department of Health and Human Services Health Resources and Services Administration Bureau of Primary Health Care Office of Quality and Data Health Center Clinical Performance Measures Purposes of Clinical Performance Measures 1. Demonstrate the value and quality of care provided by health centers 2. Focus grantee quality improvement using key health outcomes and process indicators 1
Health Center Clinical Performance Measures Baseline Measures 2008 to 2010 Newborn low birth weight Childhood immunizations In 2011 added 2 Hep A, 2 or 3 Rotavirus, and 2 flu; reduced Hep B from 3 to 2 Entry into prenatal care Cervical cancer screening Adult hypertension (blood pressure levels) Adult diabetes (HbA1c levels) In 2011 included HbA1c levels < 8 percent in addition to readings < 7 percent and > 9 percent Health Center Clinical Performance Measures New Measures in 2011 Tobacco use assessment and cessation counseling Adult weight screening and follow up Child and adolescent weight assessment and nutritional exercise/counseling Asthma pharmacological therapy Proposed Measures for 2012 Coronary artery disease lipid therapy Ischemic vascular disease aspirin or other antithrombotic therapy Colorectal cancer screening 2
Health Center Clinical Performance Measures Information Sources UDS 2010 Manual: http://bphc.hrsa.gov/healthcenterdatastatistics/repo rting/2010manual.pdf (Note: 2011 manual to be posted in November) SAC/BPR 2011: http://bphc.hrsa.gov/policiesregulations/performancemeasures/upda tedfy2012measures.pdf Health Center Clinical Performance Measures Program Assistance Letters: PAL 2010-12 2011 UDS changes http://bphc.hrsa.gov/policiesregulations/policies/pdfs/pal201 012.pdf PAL 2011-1 Proposed 2012 UDS Changes: Open for comments through November 2011 http://bphc.hrsa.gov/policiesregulations/policies/pal201201. html. 3
Health Center Clinical Performance Measures Charles A. Daly CDaly2@hrsa.gov 301-594-0818 or Heather Ngai HNgai@hrsa.gov 301-443-6430 Contact How the Program Works A program that provides immunity from lawsuit. Similar to an occurrence malpractice policy. Very successful in terms of savings for health centers and coverage of health centers and staff. 4
How the Program Works 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 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. 5
How the Program Works Who is Eligible to be Deemed: o o o o 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 Who is covered - people Employees. Officers. Directors. Governing board members. Contractors (some, not all). 6
How the Program Works 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 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. 7
How the Program Works 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 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). 8
How the Program Works 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 9
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 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. 10
FTCA Claims Procedures 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. Program Updates FTCA Branch New branch within OQD 7 staff members o Acting Branch Chief: Naomi Tomoyasu Focus on FTCA policies, procedures, and program development for Health Centers and Free Clinics FTCA Policy Manual (PIN 2011-01) http://bphc.hrsa.gov/policiesregulations/policies/pdfs/pi n201101manual.pdf 11
NEW FTCA WEBSITE http://www.bphc.hrsa.gov/ftca/ Program Updates (Continued) Focus on implementation Creation of policies and procedures Implementation of policies and procedures Reevaluation of policies and procedures Technical Assistance and Education 12
FTCA by the Dollars FTCA represents a significant savings for Health Centers Significant money spent on claims Increased focus on quality and risk management $Millions FTCA Premium Savings and Paid Claims in Millions $250 $204 $204 $209 $200 $192 $150 $100 $61.20 $52.94 $45.50 $50 $37.90 $0 FY 2007 FY 2008 FY 2009 FY 2010 Year Prem Svings (Mil) 2010 Claims by Type 168 Claims filed in 2010 Obstetricsrelated incidents lead to largest amount of claims Closely followed by diagnosis and treatment - related claims 60 50 40 30 20 10 0 52 43 39 15 14 5 Occurrences/Allegations N=168 Obstetrics Related Diagnosis Related Treatment Related Surgery Related Medication Related Other Miscellaneous 13
Types of Applications There are two types of applications for FTCA coverage: INITIAL DEEMING APPLICATION o May be submitted at any time during the year using the EHB FTCA Module o Will be acted upon by HRSA within 30 days after receipt of a completed application ANNUAL REDEEMING APPLICATION o All currently deemed health centers filed a renewal deeming application no later than July 11, 2011 in order to be deemed for CY 2012. It was extended to July 15, 2011. New Application Requirements Minutes from last six QI/QA committee meetings Remove patient names and other identifiers Minutes from the last six Board meetings that reflect Board approval of QI/QA activities Remove all information not related to QI/QA activity Board-approved Credentialing and Privileging policies Must be signed and dated by the Board 14
New Application Requirements Clinical policies and procedures for the following activities: Referral Tracking Hospitalization Tracking X-Ray Tracking Lab Result Tracking Additional Application Requirements A complete initial or redeeming application must include: 1. An Application Form completed in EHB 2. An approved Quality Improvement/Quality Assurance Plan, including governing board signature and approval date 3. 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 15
Additional Application Requirements 4. Explanation of any NO responses 5. Deeming applications for any sub-recipients (as documented on the organization s most recent approved scope from FORM 5B - see sub-recipient submission instructions. ) Additional Application Requirements 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/Position o Specialty o Employment Status (full-time employee, part-time employee, contractor, volunteer) o Date of Hire o Initial Credentialing Date (the first time the individual was credentialed by your organization) o Most Recent Credentialing Date o Next Expected Credentialing Date 16
Electronic Hand Book (EHB) Developments Automated Reminders o Notices sent to reviewers, project officers and grantees during the 10 day change request period. Enhanced Reports o Application Tracking and Progress o Submission monitoring o Program assistance support FTCA Site Visits FTCA Site Visits Focuses specifically on FTCA requirements Conducted by o FTCA Staff o MSGC Contractors o Regional Staff o Collaboration with project officers 17
FTCA Site Visits Types of Visits o Verification of Implementation o Technical Assistance and Education o Claims and Liability Issues FTCA Site Visit Guide o User friend document and report, that assists in the onsite evaluation of FTCA program requirements Future Plans FTCA Deeming PIN Clarification of Requirements Focus o QI/QA, o Application process expectations o Risk Management o Credentialing o Medical Records Goal is to release for comment in November 18
Future Plans QI/QA PIN Clarify and articulate the standards for: o QI/QA Program and Committee o QI/QA Plan o Leadership Roles in QI/QA oversight o Risk Management Program o Medical Records Goal is to release by the end of year ECRI Institute Resources Resource Page: Quality Improvement: https://members2.ecri.org/components/hrsa/pages/qi.aspx Risk Management Plan: https://members2.ecri.org/components/hrsa/pages/rmplan.aspx Event Reporting Toolkit: https://members2.ecri.org/components/hrsa/pages/eventreporttoolk it.aspx Webinars https://members2.ecri.org/components/hrsa/pages/webinar_audioco nf_archive.aspx: Clinical Risk Management Basics Part I Developing a Risk Management Plan 19
ECRI Institute 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.as px Handling Patient Complaints https://members2.ecri.org/components/hrsa/pages/oapol3.as px Safety Attitudes Questionnaire (Ambulatory Version) https://members2.ecri.org/components/hrsa/pages/psrmpol1. aspx ECRI Institute Resources Just Added!! Tracking Tool Kit Credentialing Tool Kit To Register : o E-mail: Christopher Gibbs at cgibbs@hrsa.gov o Provide the following information: Name of the health center Health Center contact information and H80 number List of the Individuals in the health center that should be given access. The list should have the following information -»Name» E-mail 20
Contact Christopher W. Gibbs, JD, MPH 56000 Fishers Lane Rockville, Maryland 20857 Cgibbs@hrsa.gov 301-594-0818 21