APPLICATION AND APPLICATION INSTRUCTIONS
OMB #0915-0293 Exp. 08/31/2008

I. PURPOSE

This Program Information Notice (PIN) provides detailed information regarding the implementation of the Free Clinics Federal Tort Claims Act (FTCA) Medical Malpractice Program (the Program) as described in Section 194 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  This PIN provides information on:

1. Who is covered;
2. What services are covered;
3. What are the Program requirements;
4. How are claims processed;
5. What is the application process; and
6. Other types of recommended insurance. 
   

II. OVERVIEW

Congress enacted  FTCA medical malpractice protection for volunteer free clinic health professionals through Section 194 of HIPAA (Public Law 104-191) by amending Section 224 of the Public Health Service Act (PHS Act) (42 U.S.C  233).   If a volunteer health care professional meets all the requirements of the Program, the related free clinic can sponsor him/her to be a "deemed" federal employee for the purpose of FTCA medical malpractice coverage.  FTCA deemed status provides the volunteer health care professional with immunity from medical malpractice lawsuits resulting from his/her subsequent performance of medical, surgical, dental or related functions within the scope of his/her work at the free clinic.  Claimants alleging acts of medical malpractice by the deemed volunteer health care professional must file their claims against the United States according to FTCA requirements.The payment of claims will be subject to the Federal government's appropriation. Free clinics must submit an annual FTCA deeming application on behalf of their volunteer free clinic health care professionals to the Department of Health and Human Services' (HHS) Health Resources and Services Administration, Bureau of Primary Health Care (HRSA, BPHC) that administers the Program.

III. WHO IS COVERED?

HHS will deem a volunteer free clinic health care professional to be a federal employee for the purposes of FTCA coverage for medical malpractice claims if the free clinic and health care professional meet certain requirements. 

A free clinic is a health care facility operated by a nonprofit private entity that:

1. In providing health care, does not accept reimbursement from any third-party payor (including reimbursement from any insurance policy, health plan, or Federal or State health benefits program);
2. In providing health care, does not impose charges on patients to whom service is provided OR imposes charges on patients according to their ability to pay[1];
3. May accept patients' voluntary donations for health care service provision; and
4. Is licensed or certified to provide health services in accordance with applicable law.

A volunteer free clinic health professional : 

1. Provides services to patients at a free clinic or through offsite programs or events carried out by a free clinic;
2. Is sponsored by a free clinic;
3. Provides a qualifying health service (i.e., any medical assistance required or authorized to be provided under Title XIX of the Social Security Act (42 U.S.C. 1396 et. seq.)) without regard to whether the medical assistance is included in the plan submitted by the State in which the health care practitioner provides the service;
4. Does not receive compensation for provided services from patients directly or from any third-party payor;
5. May receive repayment from a free clinic for reasonable expenses incurred in service provision to patients;
6. Is licensed or certified to provide health care services [2]at the time of service provision in accordance with applicable law; and
7. Provides patients with written notification before service provision of the extent to which his/her legal liability is limited pursuant to the PHS Act if his/her associated free clinic has not already provided such notification (see Section V(B)). 

An example of a FTCA covered offsite program or event carried out by a free clinic is a health fair sponsored by the free clinic.  If a free clinic is unsure whether an offsite program or event is covered by FTCA, the free clinic may apply to the HRSA Associate Administrator for Primary Care (through the free clinics FTCA Program) for a determination of coverage.  The request must sufficiently detail:

1. What service(s) is being provided;
2. Who is providing the service;
3. Where the service is being provided; and
4. Why the free clinic volunteer(s) is providing the service.

IV. WHAT SERVICES ARE COVERED? 

1. Arise from services required or authorized to be provided under Title XIX of the Social Security Act (i.e., Medicaid Program) regardless of whether the service is included in the State Medicaid plan in effect for the volunteer free clinic health care professional's work site(s);
2. Arise from the provision of medical, surgical, dental or related services at a free clinic site or through offsite programs or events carried out by the free clinic; and
3. Occur on or after the effective date that the HHS Secretary approves the FTCA deeming application submitted by the free clinic on behalf of its volunteer free clinic health care professionals.  

V.  WHAT ARE THE PROGRAM REQUIREMENTS?

A. Credentialing and Privileging

Credentialing and Privileging Definitions

HHS will deem a volunteer free clinic health care professional to be a federal employee for purposes of FTCA coverage for medical malpractice claims if specific credentialing and privileging requirements are met.  For the purposes of the Program:

1. Credentialing is the process of assessing and confirming the qualifications (e.g., licensure, certification, and/or registration) of a licensed or certified health care practitioner; and
2. Privileging is the process of authorizing the specific scope and content of patient care services of a licensed or certified health care practitioner. This is performed in conjunction with an evaluation of the health care practitioner's clinical qualifications and/or performance.

Free Clinics can satisfy many of the credentialing and privileging requirements by utilizing primary and secondary source verification.  For the purposes of the Program:

1. Primary source verification is verification of an individual health care practitioner's reported qualification by the original source or an approved agent .  Examples of primary source verification of credentials include direct correspondence, telephone verification, or internet verification from the original qualification source or reports from credentials verification organizations (CVOs). For example, the Education Commission for Foreign Medical Graduates (ECFMG), the American Board of Medical Specialties (ABMS), the American Osteopathic Association (AOA) Physician Database, or the American Medical Association (AMA) Masterfile can be used for primary source verification of health care practitioners' education and training.  Hospitals also can serve as CVOs to conduct primary source verification for free clinics.  When using a CVO for primary source verification, the free clinic is relieved from the process of gathering the information, but it is not relieved from the responsibility of having complete and accurate information.  Therefore, a free clinic that bases its decisions in part on information obtained from a CVO should achieve a level of confidence in the information provided by the CVO (For more information, consult Credentialing and Granting of Privileges , 2004 Comprehensive Accreditation Manual for Ambulatory Care, Joint Commission on Accreditation of Healthcare Organizations (JCAHO), pg. HR-10).
2. Secondary source verification is verification by methods not considered acceptable for primary source verification .  Examples of secondary source verification of credentials include viewing the original credential, a notarized copy of the credential, or a copy of the credential (when the copy was made from an original by an authorized participant of the organization's credentialing process).

Only volunteer health care professionals who are licensed or certified are eligible for FTCA deemed status (see Section III).  Licensed or certified health care practitioners can be divided into two categories:

1. A licensed independent practitioner (LIP) is a physician, dentist, nurse practitioner, nurse midwife, or any other individual permitted by law and the organization to provide care and services without direction or supervision , within the scope of the individual practitioner's license and consistent with individually granted clinical privileges; and
2. An other licensed or certified health care practitioner is an individual who is licensed, registered, or certified but is not permitted by law to provide patient care services without direction or supervision . Examples include, but are not limited to, laboratory technicians, social workers, medical assistants, licensed practical nurses, and dental hygienists.

Credentialing and Privileging Requirements
The free clinic must determine whether each volunteer health care professional meets the definition of a LIP or other licensed or certified health care practitioner based on State law and the free clinic's policies.   Further, the free clinic must assure that these licensed or certified health care practitioners are credentialed and privileged.  Credentialing and privileging requirements differ depending on whether the volunteer health care professional is a LIP or other licensed or certified health care practitioner.

Initial Credentialing of LIPs

The initial credentialing of LIPs should include:

1) Primary source verification of:

1. Current licensure;
2. Relevant education, training, or experience; and
3. Health fitness or the ability to perform the requested privileges (This can be determined by a statement from the individual that is confirmed either by the director of a training program, chief of staff/service of a hospital where the individual has privileges, or a licensed physician designated by the organization);

2) Secondary source verification of:

1. Identification (via a government issued picture id);
2. Drug Enforcement Administration registration, as applicable;
3. Hospital admitting privileges, as applicable;
4. Immunization and PPD status; and
5. Life support training, as applicable; and
   

3) Querying the National Practitioner Data Bank (NPDB), as applicable (If the free clinic is ineligible to query the NPDB, it should have the LIP provide the results of a self-query).

The free clinic should complete the credentialing process for the LIP prior to the practitioner providing patient care services at the free clinic.

Initial Privileging of LIPs
The initial privileging of a LIP involves the assessment of his/her current competence in the specific scope or content of patient care services he/she is to provide at the free clinic.  The free clinic should assure that the specific assessment procedures utilized are appropriate for the LIP's specialty, breadth of clinical services to be provided to patients, and accessibility to ancillary and tertiary medical practitioners.  A free clinic could assess a LIP's competence by any combination of: 2) Documentation of first hand, one-on-one review of the LIP's competence in particular procedures or management protocols by a supervising clinician who possesses privileges in the particular procedures or management protocols; and/or 3) Direct proctoring of the LIP in particular procedures or management protocols by a qualified clinician possessing a degree of expertise in the particular procedures or protocols beyond the level of expertise of most primary care providers.

Approval Authority for Initial LIP Credentialing and Privileging
The free clinic's governing board should state in writing its determination that a LIP meets credentialing and privileging requirements.  This determination can be based on the recommendation of the Medical Director or the combined recommendation of medical staff (including the Medical Director) and the Executive Director.  Alternatively, the governing board may delegate this responsibility (via resolution or bylaws) to an appropriate individual to be implemented based on approved policies and procedures (including methods to assess compliance with these policies and procedures).

Temporary Privileging Requirements for LIPs
The free clinic should strive to complete the privileging process prior to the LIP being allowed to provide patient care services.  However, if the free clinic has established temporary privileging policies and procedures, it can grant temporary privileges to a LIP:

1) To meet important patient care needs for a limited period of time [3](requires verification, which can be done by phone, of the provider's current licensure and current competence in the specific scope or content of patient care services he/she is to provide at the free clinic); or

2) To issue privileges for new volunteer free clinic health care professionals for a period not to exceed 120 days, requiring verification of:

1. Current licensure;and that there is no history of current or previously successful challenges to licensure (can be done by phone);
2. Relevant training and experience (can be done by phone); 
3. Current competence in the specific scope or content of patient care services he/she is to provide at the free clinic and ability to perform the privileges requested (can be done by phone);
4. NPDB history;
   1. History of involuntary termination of medical staff membership at another organization (i.e., confirming that there is no history of this); or
   2. History of involuntary limitations, reduction, denial, or loss of clinical privileges (i.e., confirming that there is no history of this)
   3. Other criteria required by the policies and procedures of the free clinic (can be done by phone). 

Free clinics should not provide temporary privileges for situations in which: 

1. The LIP fails to provide all information necessary for the privileging process; or
2. Free clinic staff fail to verify performance data and other information in a timely manner.

In these situations, the free clinic must require that the LIP cease providing patient care in the free clinic until the privileging process is completed. 

Initial Credentialing of Other Licensed or Certified Practitioners

The initial credentialing of other licensed or certified practitioners should include:

1) Primary source verification current licensure, registration, or certification;

2) Secondary source verification of:

1. Education and training;
2. Identification (via a government issued picture id);
3. Drug Enforcement Administration registration, as applicable;
4. Hospital admitting privileges, as applicable;
5. Immunization and PPD status;
6. Life support training, as applicable; and

3) Querying the NPDB , as applicable (If the free clinic is ineligible to query the NPDB, it must have the licensed or certified practitioner provide the results of a self-query).

A free clinic also may choose to credential other licensed or certified health care practitioners via similar requirements utilized for LIPs.  Free clinics must complete the credentialing process for other licensed or certified health care practitioners prior to the practitioners providing patient care services at the free clinic.

Initial Privileging of Other Licensed or Certified Practitioners

The Executive Director should state in writing his/her determination that an other licensed or certified health care practitioner meets credentialing and privileging requirements.  This determination should be based on the Medical Director's review of credentialing information and the supervisor's evaluation of the practitioner's clinical qualifications and performance. 

Alternatively, the Executive Director may delegate this responsibility (via resolution or bylaws) to an appropriate individual to be implemented based on approved policies and procedures (including methods to assess compliance with these policies and procedures).

The free clinic should reassess the credentials and privileges of LIPs and other licensed or certified health care practitioners at least every 2 years.  Renewed credentialing and privileging processes should include:

1) Primary source verification of current licensure, registration or certification;

2) Secondary source verification of:

1. Confirmation of adherence to the free clinic's policies, procedures and rules;
2. Relevant education training and experience (if changed since initial appointment);
3. A statement that the individual can perform the care, treatment and services he or she has been providing; and
4. Restrictions on privileges at the other health care organizations.

3) An assessment of current competency to include:

1. A synopsis of peer review results from the prior 2 year period and/or any relevant performance improvement information (for LIPs); or
2. The supervisors' evaluation of performance (for other licensed or certified health care practitioners); and

4) Querying the NPDB, as applicable.

The free clinic should notify LIPs and other licensed or certified health care practitioners that they have successfully completed the renewed credentialing and privileging processes in the same manner used for initial credentialing and privileging.

The free clinic should have an appeal process that a LIP can undertake if the free clinic decides to discontinue or deny his/her clinical privileges. An appeal process is optional for other licensed or certified health care practitioners.

A FTCA deemed volunteer free clinic health care professional or the free clinic must provide each patient with written notification of the limited liability of the health care professional pursuant to FTCA.  The volunteer health care professional and/or free clinic can satisfy this statutory requirement by having each patient review a notification document prior to the first encounter between the patient and the health care professional.  It is preferable that the health care practitioner or free clinic obtain the patient's signature on the notice and include the notice in the patient's medical record.  If the volunteer health care professional is providing emergency care, the health care professional or free clinic may provide the written notice as soon thereafter as is practicable.  The health care professional or free clinic should provide the notice to a parent or legal guardian when the patient lacks legal responsibility for his/her care under the law of the State where care is provided. 

A sample patient notice can be found in Appendix C.  Free clinics also may choose to develop their own patient notice form.  The free clinic's form must at a minimum address all of the requirements listed in the sample.

VI.  HOW ARE CLAIMS PROCESSED?

Claimants alleging acts of medical malpractice by a FTCA deemed volunteer free clinic health care professional must file their claims against the United States according to FTCA requirements.  FTCA requires that the alleged injured party file an administrative claim with HHS prior to instituting any court action. 

Upon receipt of the claim, HHS will determine whether FTCA medical malpractice coverage applies to the particular claim if the alleged act or omission giving rise to the claim:

1. Involved a volunteer free clinic health care professional with deemed FTCA status pursuant to the PHS Act;
2. Involved a health care service qualifying for FTCA coverage; and
3. Occurred at a free clinic or a covered offsite program or event carried out by the free clinic. 

If HHS denies the claim or HHS action is pending after 6 months, the claimant can file suit against the United States.  FTCA medical malpractice cases are heard in federal district court without a jury and are defended by the Department of Justice with the assistance of the Office of General Counsel, Department of Health and Human Services.  No punitive damages are allowed.   

VII. WHAT IS THE APPLICATION PROCESS?

A. Overview

A free clinic must sponsor each volunteer free clinic health care professional that participates in the Program. A free clinic can sponsor volunteer free clinic health care professionals by submitting a FTCA deeming application to the HHS Secretary through the Free Clinics FTCA Program. This application is attached (see Appendices). The free clinic can download additional deeming applications from the W eb. Free clinics should submit

1. One electronic copy and one hard copy of all application materials;  OR
2. Two hard copies of all application materials to:

Free Clinics FTCA Program
Division of Clinical Quality
Bureau of Primary Health Care, HRSA
Room 17C-26, 5600 Fishers Lane
Rockville, MD 20857

FreeClincsFTCA@hrsa.gov (for electronic submissions)

Failure to submit any of the requested information will render the application incomplete.  The application will not be considered until the missing information is provided.

B. Original Deeming Application

A free clinic may submit an original FTCA deeming application at any time after the effective date of this notice.  The original deeming application requires information fulfilling statutory and programmatic requirements, including (see Appendix A): 

1. Contact information of the sponsoring free clinic;
2. Location and managers of free clinic sites;
3. Description of the free clinic's credentialing and privileging systems;
4. Description of the free clinic's risk management systems;
5. List of all volunteer health care professionals that the free clinic is sponsoring for FTCA deemed status;
6. Description of all medical malpractice claims alleged against the free clinic's health care professionals (including pending claims);
7. Requested effective date of FTCA coverage; and
8. Approval signatures of senior free clinic managers.

HRSA's Associate Administrator for Primary Care will make final decisions regarding FTCA deeming of volunteer free clinic health care professionals within 30 days of receipt of a complete application.  The HRSA Associate Administrator will provide the free clinic with written notification of the effective date of its volunteer health care professionals' FTCA deemed status.  Original deeming will be valid through the remainder of the calendar year. 

C. Annual Renewal Deeming Application

The free clinic subsequently can sponsor volunteer health care professionals annually by submitting a FTCA annual renewal application.  The original deeming letter from the HRSA Associate Administrator will list the due date for annual renewal applications that will stagger free clinics' application submission dates. 

The HRSA Associate Administrator will make final decisions regarding FTCA deeming renewal of volunteer free clinic health care professionals.  If the renewal application is approved, in December, the HRSA Associate Administrator will provide the free clinic with written notification of its volunteer health care professionals' FTCA deemed status that will be valid through the subsequent calendar year. 

D. Supplemental Deeming Application

If a free clinic desires FTCA coverage of additional volunteer free clinic health care professionals prior to the due date for the annual renewal application, the free clinic must submit a supplemental deeming application (see Appendix B) that contains:

1. Contact information of the sponsoring free clinic;
2. Location and managers of any new free clinic sites since its last FTCA application submission;
3. Certification that the free clinic has maintained its credentialing, privileging, and risk management systems or a description as to how the system(s) has been modified;
4. List of all new volunteer health care professionals that the free clinic is sponsoring for FTCA deemed status;
5. A description of all medical malpractice claims alleged against the free clinic's newly sponsored volunteer health care professionals;
6. Requested effective date of FTCA coverage; and
7. Approval signatures of senior free clinic managers.

Supplemental deeming will be valid through the remainder of the calendar year. 

VIII.    TYPES OF RECOMMENDED INSURANCE 

The Program provides protection only from allegations of medical negligence for volunteer free clinic health professionals as defined in Section III of this PIN.  Other free clinic staff and the free clinic corporation are not covered under FTCA.  Additionally, the Program does not provide protection against perils normally protected by general liability and directors and officers' insurance policies.  Free clinics should consult with their insurance agents to determine their needs for protection beyond the Program.

IX.   APPENDICES

Appendix A           

Deeming Application - Original or Annual Renewal
A.1 - Application Form
A.2 - Application Checklist

Appendix B           
Deeming Application - Supplemental
B.1 - Application Form
B.2 -Application Checklist

Appendix C            
Sample Patient Notice of Limited Liability of FTCA Deemed Volunteer free Clinic Health Professionals

Appendix A.1

SECTION I -SPONSORING FREE CLINIC

SECTION II -FREE CLINIC SITES
List all free clinic sites where volunteer health care professionals will be providing services.

Please make additional copies of this page to list any additional sites.

Please answer YES or NO to the following questions by marking in the appropriate box. 

" NO" answers require an explanation in Section V.

Please answer YES or NO to the following questions by marking in the appropriate box.

Explanations of each "No" answer from Sections III & IV.
(Please identify each response with the corresponding Section number and letter.)

Please attach additional pages, if needed.

 SECTION VI -  FREE CLINIC VOLUNTEER HEALTH CARE PROFESSIONALS

List of all volunteer free clinic health care professionals that the free clinic wants to sponsor for FTCA deemed status. 

Please attach additional sheets, if needed.

(original deeming )  Describe all medical malpractice claims against the free clinic and/or
its sponsored volunteer health care professionals occurring prior to the submission of this FTCA application.

(annual renewal deeming) Describe all FTCA medical malpractice claims against the free clinic, its deemed health care professionals, and/or its newly sponsored volunteer health care professionals since the last FTCA application submission.

Please make additional copies of this page to list additional claims.

SECTION VIII - SIGNATURES

Appendix A.2

Volunteer Free Clinic Health Professional Deeming Application - Original or Annual Renewal

ITEM COMPLETED AND/OR ATTACHED

Appendix B.1

SECTION I -SPONSORING FREE CLINIC

Please make additional copies of this page to list any additional sites.

Please attach additional sheets, if needed.

SECTION IV -  FREE CLINIC VOLUNTEER HEALTH CARE PROFESSIONALS

List of all new volunteer free clinic health care professionals that the free clinic wants to sponsor for FTCA deemed status

(i.e., those not included in the last FTCA deeming application). 

Please attach additional sheets, if needed.

Describe all medical malpractice claims against the free clinic's newly sponsored volunteer health care professionals.

Please make additional copies of this page to list additional claims.

Appendix B.2

ITEM COMPLETED AND/OR ATTACHED

State document indicating legal name change is attached if legal name change occurred since last deeming application was submitted.

Section II -Free Clinic Sites

Free clinic sites that were not included in the last deeming application are listed, using additional copies of Section II, if needed.

Each site is appropriately identified as the main or an additional site.

Section III -Credentialing, Privileging, and Risk Management Systems Certification

An explanation of any changes in the free clinic's credentialing, privileging and risk management systems since the original or annual renewal application is included, if applicable. 

Section IV - Free Clinic Health Professionals

All free clinic health professionals not listed in the last deeming application that the free clinic wants to sponsor for FTCA deemed status are listed.

Original signatures are included for the free clinic's Executive and Medical Directors.

Appendix C

Notice to Patients

To be provided to the individual patient before health care services are provided,
except in emergency cases when notice may be provided as soon after the emergency as is practicable or to a parent or legal guardian when the patient lacks legal responsibility for his/her care under State law.

This is to notify you that under Federal law relating to the operation of free clinics, the Federal Tort Claims Act (FTCA), (See 28 U.S.C. §§ 1346(b), 2401(b), 2671-80) provides the exclusive remedy for damage from personal injury, including death, resulting from the performance of medical, surgical, dental, or related functions by any free clinic volunteer health care practitioner who the Department of Health and Human Services has deemed to be an employee of the Public Health Service.  This FTCA medical malpractice coverage applies to deemed free clinic volunteer health care practitioners who have provided a required or authorized service under Title XIX of the Social Security Act (i.e., Medicaid Program) at a free clinic site or through offsite programs or events carried out by the free clinic (See 42 U.S.C. § 233(a), (o)).

Certain free clinic health care professionals providing health care services to patients at this free clinic may be covered by the above Federal law.

Acknowledged:  ________________________________(patient signature)

                        ________________________________(patient name, printed legibly)

    Date:  ____________

[1] If the free clinic imposes charges based on a patient's ability to pay, this will negate the FTCA coverage of the volunteer(s) for the specific services for which the clinic received payment.

[2] A licensed or certified health care practitioner is an individual required to be licensed, registered, or certified by the State, Commonwealth or territory in which a Free Clinic is located. These individuals include, but are not limited to, physicians, dentists, registered nurses, and others required to be licensed, registered, or certified (e.g., laboratory technicians, social workers, medical assistants, licensed practical nurses, dental hygienists, and nutritionists). The definition will vary dependent upon legal jurisdiction.

[3] Examples of cases in which a free clinic could grant temporary privileges to a LIP in order to meet important patient care needs for a limited period of time include: 

1. A current LIP becomes ill or takes a leave of absence, and another LIP is needed to cover patient care until the current LIP returns; or
2. A current LIP does not have the necessary skills to provide needed patient care.