Policy AD-470 FTCA-Related Claims Management 2023-06-21

Purpose

This policy is intended to ensure that Westside Family Healthcare, Inc. (Westside) meets its obligations as an FTCA-deemed health center organization and has a claims management process in place for addressing any potential or actual health or health-related claims, including medical malpractice claims, that may be eligible for FTCA coverage.

This policy also serves to ensure that Westside follows the requirements in HRSA’s Federal Tort Claims Act (FTCA) Health Center Policy Manual for its FTCA-related claims management.

Policy

As an FTCA-deemed HRSA-funded Federally Qualified Health Center (FQHC), Westside follows the appropriate federal guidelines and legal requirements outlined by the HRSA Health Center Program and HHS Office of the General Counsel for managing potential or actual FTCA-eligible claims, including but not limited to:

• Designation of a responsible party and point-of-contact;
• Immediate response to premature lawsuits;
• Preparation and submission of complete documentation for claims processing and certification of scope of employment; and
• Retention of all requested and potentially relevant claims-related records.

Scope

This policy applies to Westside Family Healthcare, Inc., including all Westside health centers and administrative offices, and to all claims involving Westside FTCA-covered board members, officers, employees, contractors, providers (including but not limited to physicians, physician assistants, nurse practitioners, nurses, dentists, and dental hygienists).

Definitions

Federal Tort Claims Act (FTCA) – The Federal Tort Claims Act (FTCA) is a 1946 federal statute that permits private parties to bring a lawsuit against (sue) the United States in a federal court for negligent or wrongful acts or omissions (most torts) committed by federal employees acting within the scope of their official duties.  Under the FTCA, the federal government acts as a self-insurer and recognizes liability for such acts or omissions by its employees.  The statute substitutes the United States as the defendant in such a suit, and the United States – not the individual employee – bears any resulting liability.  (The FTCA legislation can be found at 28 U.S.C. § 1346(b), 2401(b), 2671-80.)

FTCA Health Center Coverage – The Federally Supported Health Centers Assistance Acts (FSHCAA) of 1992 and 1995 extend FTCA protections to eligible health centers funded under the HRSA Health Center Program, section 330 of the Public Health Service (PHS) Act.  Westside is a grantee funded under section 330 of the PHS Act.

Through the Federal Tort Claims Act (FTCA), eligible HRSA-supported health centers such as Westside may be granted medical malpractice liability protection with the federal government acting as their primary insurer.  This program is sometimes referred to as the Health Center FTCA Medical Malpractice Program.

FTCA Health Center Deeming – To receive coverage, eligible grantees submit a deeming application to the Health Resources and Services Administration (HRSA) Bureau of Primary Health Care (BPHC) and meet the requirements to attain deemed status.  Renewal applications for redeeming are submitted on an annual basis to continue coverage.  Westside was initially FTCA-deemed by HRSA in 1999 and has been re-deemed annually.

FTCA-Covered Individuals and Activities – FTCA liability protection for medical malpractice is extended to any eligible officer, governing board member, employee, or qualified contractor of a covered health center (subject to the requirements of the PHS Act).  FTCA coverage is afforded to covered individuals by virtue of their working relationship with the covered entity.  Covered individuals (such as those at Westside) are considered federal employees (Public Health Service) and, thus, are immune from personal liability for claims of medical malpractice arising from their employment, contract for services, or duties as an officer or director of the deemed health center.  

Covered activities include those activities that: 1.) are approved within each individual’s scope deemed of employment (this term includes activities within an applicable individual contract for services with the health center); 2.) are within the scope of the approved Federal section 330 grant project of the deemed health center; and 3.) take place during the provision of services to health center patients and, in certain circumstances, to non-health center patients.

Claims Filed Under the FTCA – A patient who alleges acts of medical malpractice by a deemed health center (such as Westside) cannot sue the health center or the provider(s) directly, but must file the claim against the United States Government. The Federal government assumes responsibility for costs related to a claim resulting from the performance of a medical, surgical, dental, or related function. There is no cost to a participating health center or its providers. These claims are reviewed and/or litigated by the U.S. Department of Health and Human Services, Office of the General Counsel and the Department of Justice according to FTCA requirements.

Procedures

Claims Management Requirements of FTCA-Deemed Health Centers

• 1. Claims Management Process
     1. Westside has a claims management process for addressing any potential or actual health or health-related claims, including medical malpractice claims, that may be eligible for FTCA coverage, as outlined in the procedures contained in this policy AD-470.
     2. This claims management process ensures:
        1. The preservation of all health center documentation related to any actual or potential claim or complaint (for example, medical records and associated laboratory and x-ray results, billing records, employment records of all involved clinical providers, clinic operating procedures); and
        2. Any service-of-process/summons that the health center or its provider(s) receives relating to any alleged claim or complaint is promptly sent to the HHS Office of the General Counsel, General Law Division, per the process prescribed by HHS in the FTCA Health Center Policy Manual and as described below.
  2. Designated Responsible Party and Claims Activities Point-of-Contact
     1. The Chief Operating Officer (COO) (or an appointed proxy), in collaboration with the Corporate Compliance Officer, is responsible for the management and processing of claims-related activities and serves as the claims point-of-contact for Westside Family Healthcare.  
  3. Informing Patients of FTCA Deemed Status
     1. Westside informs patients by (1) using plain language that it is an FTCA-deemed federal Public Health Service (PHS) employee with a statement on the bottom of the main page of the Westside website, which includes a link to the HRSA FTCA FAQ page and (2) placing the FSHCAA FTCA Deemed Status Badge provided by HRSA on its website.
        1. The statement is: “This federally qualified health center and its employees are deemed to be federal employees and accordingly are covered by the Federal Tort Claims Act.”
           1. The FTCA FAQ link provided is: https://bphc.hrsa.gov/initiatives/ftca/faq
        2. Westside uses and displays the FSHCAA FTCA Deemed Status Badge following HRSA’s Guidelines for Use and Display Guidelines.
           1. HRSA guidelines for use of the FTCA Deemed Status Badge are provided at: https://bphc.hrsa.gov/initiatives/ftca/status-badge
  4. History of Claims: Cooperation and Mitigation
     1. When a history of claims under the FTCA exists, Westside can document that it:
        1. Cooperated with the Attorney General, as described in the FTCA Health Center Policy Manual; and
        2. Implemented steps to mitigate the risk of such claims in the future.
  5. Westside uses HRSA’s Federal Tort Claims Act Health Center Policy Manual as its primary resource for understanding its obligations as an FTCA-deemed health center, as defined by HRSA BPHC.  
     1. Other important reference documents are listed in the Reference section of this policy.

Claimant Responsibilities Under the FTCA

• 1. A claimant is a Westside health center patient alleging negligent or wrongful acts or omissions by Westside Family Healthcare or one or more Westside employees or contractors acting within the scope of their official duties.  Westside understands that a claimant’s responsibilities when filing a claim under the FTCA are as follows:
     1. Administrative Remedy: A claimant must first seek an administrative remedy by presenting his or her claim to the HHS Office of the General Counsel (OGC), General Law Division (GLD), Claims and Employment Law Branch (CELB). Under the FTCA, if the claim is denied or a settlement is not reached within six months of such presentment, the claimant can sue the United States in the appropriate Federal district court. Alternatively, a claimant may request reconsideration of the denial of an administrative tort claim within six months after issuance of the denial.
     2. Litigation: Once an administrative claim has been denied by HHS, the claimant must file suit within six months in the appropriate Federal district court (or seek reconsideration by HHS/OGC) or the action will be time-barred. Cases are heard in Federal district court without a jury, and are defended by the Department of Justice (DOJ) with the assistance of HHS OGC.
  2. Occasionally, a claimant erroneously files a lawsuit in State court in lieu of filing an administrative claim with HHS or less than six months after filing an administrative claim with HHS. These lawsuits are termed premature lawsuits.
  3. Westside educates its patients on claimant responsibilities and these HHS procedures when information is requested.

Appendix A: Federal Tort Claims Process for Deemed HRSA-Funded Health Center outlines both the Administrative Claims Process with the Department of Health and Human Services (HHS) and the filing and hearing of a lawsuit in Federal court with the Department of Justice (DOJ).  

• 1. The diagram applies to Westside Family Healthcare, as an FTCA-deemed health center, and to any Westside health center patient claimant.  

Westside (FTCA-covered entity) Responsibilities in the Case of Premature Lawsuits

• 1. In the event that a claimant erroneously files a claim with or serves premature lawsuit documentation to a Westside Family Healthcare entity or individual (administrative office, health center, provider, employee or contractor, or any other Westside-affiliated entity or individual), the Chief Operating Officer and Corporate Compliance Officer will be informed right away.
  2. Westside must immediately fax or e-mail a copy of all documentation provided by the claimant to the Department of Health and Human Services, Office of the General Counsel, General Law Division, Claims and Employment Law Branch (OGC/GLD/CELB) using the contact information for Claims and Lawsuits listed on Appendix B: FTCA Contact Information.
  3. With regard to premature lawsuits in which a claimant files a lawsuit against a covered entity in State court, Westside (or its private counsel) will follow HRSA’s strong advice to make arrangements to obtain at least a 60-day extension from the state court to answer the complaint.
  4. In the case of all premature lawsuits, Westside will immediately call or email OGC/GLD/CELB and ask to speak to any of the CELB FTCA attorneys for advice on how to proceed.  Prompt notification of the litigation is critical so that the action may be removed to Federal district court and the United States substituted as the named defendant.

Required Documentation for Claims Processing and Certification of Scope of Employment

• 1. The applicability of the FTCA to a particular claim or case will depend upon verification by HHS OGC and/or certification by the United States Attorney, as appropriate, that:
     1. The entity and individual are covered by the Act;
     2. The covered individual was acting within the scope of employment;
     3. The act or omission giving rise to the claim was within the approved scope of project of the covered entity; and
     4. The act or omission giving rise to the claim occurred during the provision of services to covered entity patients and certain, limited non-health center patients.
  2. Such certification or failure to certify is subject to judicial review.
  3. Westside will prepare all required documents identified in Appendix C:  Required Documents for Premature Lawsuits and Claims Disposition for use by OGC/GLD/CELB to verify a covered entity’s FTCA claim eligibility.
     1. The verification process confirms that the covered entity and the covered individuals were performing within the approved scope of project and scope of employment, contract for services, or duties as an officer or director of the covered entity pursuant to FTCA at the time of the incident in question.
  4. Westside will ensure that the dates of the documents correspond to the dates of the incident.
  5. Upon HHS OGC request, Westside will submit to HHS OGC, as applicable, all required documentation, with tabs matching each of the individual items listed on Appendix C using the using the address information for Claims and Lawsuits provided on Appendix B.

Confirmation of Documentation Receipt

• 1. Westside Family Healthcare will confirm receipt of all documents that it emails or faxes to HHS/OGC/GLD/CELB using the telephone number provided under the Claims and Lawsuits category in Appendix B: FTCA Contact Information – (202) 691-2369.

Essential and Requisite Document Retention

• 1. When a claim or lawsuit involving Westside is presented or filed, it is essential that the organization and all involved individuals preserve all potentially relevant claims-related documents (e.g., medical records and associated laboratory and x-ray results, billing records, employment records of all involved clinical providers, and clinic operating procedures).
  2. Once Westside Family Healthcare or a Westside FTCA-covered individual reasonably anticipates litigation—and it is reasonable to anticipate litigation once a claim or lawsuit is filed, whether administratively or in state or federal district court—the organization or individual must suspend any routine destruction and hold any documents relating to the claimant or plaintiff so as to ensure their preservation.

Additional and more detailed information regarding document retention will be provided by HHS after a claim or lawsuit is filed. However, Westside must be aware of this requirement, act accordingly whenever a claim or lawsuit is filed, and seek further guidance from HHS OGC before destroying any potentially relevant documents.

Contacting the FTCA with Questions or Concerns

• 1. Whenever any questions or concerns arise related to FTCA coverage or the FTCA claims process, Westside will promptly contact either HRSA’s Health Center Program Support or the HHS Office of the General Counsel using the contact information for the appropriate category, as indicated in Appendix B: FTCA Contact Information.

Statute of Limitations

• 1. Under title 28, section 2401(b) of the FTCA, a claim must be presented within two years after the claim accrues. Generally, accrual occurs on the date of the injury.
  2. However, Federal case law also incorporates a discovery rule for determining claim accrual or starting date for the statute of limitations. Under the discovery rule, the statute of limitations commences when a person discovers, or in the exercise of reasonable care should discover, injury due to another’s negligence.
  3. State statute of limitations periods do not apply to claims filed under the FTCA.

References

1. HRSA Bureau of Primary Health Care (BPHC) Federal Tort Claims Act (FTCA) Program
   1. Main web page: https://bphc.hrsa.gov/initiatives/ftca
   2. HRSA Program Assistance Letter (PAL) 2023-01, Calendar Year 2024 Requirements for Federal Tort Claims Act (FTCA) Coverage for Health Centers and Their Covered Individuals, February 2, 2023.  (https://bphc.hrsa.gov/sites/default/files/bphc/compliance/pal-2023-01.pdf)
2. HRSA Compliance Manuals:
   1. HRSA Health Center Program Compliance Manual, Chapter 21: Federal Tort Claims Act (FTCA) Deeming Requirements, August 2018, 84-87. https://bphc.hrsa.gov/compliance/compliance-manual/chapter21
   2. HRSA Federal Tort Claims Act (FTCA) Health Center Policy Manual, July 21, 2014. https://bphc.hrsa.gov/sites/default/files/bphc/ftca/pdf/ftcahcpolicymanualpdf.pdf
      1. Updated in 2014 to reflect amendments to the FTCA Health Center regulations, set forth in the Code of Federal Regulations, title 42, part 6 (42 CFR part 6).
3. HRSA Site Visit Protocols:
   1. Federal Tort Claims Act (FTCA) Deeming Requirements, HRSA Health Center Program Site Visit Protocol, April 13, 2023, pp. 152-160. https://bphc.hrsa.gov/compliance/site-visits/site-visit-protocol/federal-tort-claims-act-ftca-deeming-requirements
   2. Federal Tort Claims Act (FTCA) Health Center Program Site Visit Protocol https://bphc.hrsa.gov/initiatives/ftca/site-visit-protocol

Note: Much of the language used in this policy is either adapted or directly excerpted from HRSA’s FTCA website or the HRSA Federal Tort Claims Act Health Center Policy Manual.

APPENDIX A:

FEDERAL TORT CLAIMS PROCESS

FOR DEEMED HRSA-FUNDED HEALTH CENTER

APPENDIX B:

FTCA CONTACT INFORMATION

APPENDIX C:

REQUIRED DOCUMENTS FOR

PREMATURE LAWSUITS & CLAIMS DISPOSITION

1. Three copies of the summons and complaint.
2. Three copies of the covered entity’s initial deeming letter and all subsequent redeeming documentation including Notices of Grant Award (NGAs) containing re-deeming language or re-deeming letters, as appropriate.
3. Three copies of the covered entity’s Federal section 330 grant application and Forms 5-A, 5-B and 5-C setting forth the approved scope of project including delivery sites and services, for the period of time covered by the claim.
4. Three copies of a statement, on covered entity letterhead, identifying which providers are involved or named in the claim and their dates of employment at the covered entity (if not already provided for a premature lawsuit relating to the same incident).
5. Evidence that the named providers were licensed physicians or licensed or certified health care providers at the time of the incident, including documentation of the specialty of all named providers.
6. In the event this alleged incident arises from acts or omissions that occurred outside of the covered entity’s approved service sites, the name and address of the outside facility and information as to the nature of the affiliation between the outside facility, health center and its personnel.
7. Three copies of the Wage and Tax statements (W-2) for each individual involved in the alleged incident for the period of time covered by the claim.
8. If the provider whose care is at issue was a licensed or certified health care provider contractor at the time of the alleged incident, three copies of the 1099 form; an employment contract covering the period of the alleged incident; and evidence that the health care provider contractor was working full time, an average of 32.5 hours per week, or if employed part time, that the health care provider contractor was providing services only in the fields of family practice, obstetrics and gynecology, general internal medicine or general pediatrics.
9. Three copies of a declaration verifying the employment of each individual involved in the alleged incident on the health center’s letterhead, signed by each provider whose care is at issue. The declaration should state that to the best of his/her knowledge, the named provider was not billing privately, or, if the named provider was billing privately, he/she complied with the alternate billing arrangement requirements.
   1. Note: Westside should attempt to obtain a declaration from each named provider involved in the alleged incident; if the named provider is not available, the health center should document attempts to obtain the statement.
   2. The Chief Executive Officer (CEO) may sign the declaration only if all reasonable attempts have been made to obtain the statement from the named provider and documentation of these attempts is included with the CEO’s declaration. The CEO’s declaration should state that to the best of her knowledge, the named provider was not billing privately, or, if the named provider was billing privately, she complied with the alternate billing arrangement requirements.
10. Three copies of any professional liability or gap insurance policy that provides coverage to the health center and the named provider. The policies must cover the dates of the alleged incident. If neither the covered entity nor the named provider involved in the alleged incident has medical malpractice coverage other than that provided under FTCA, the covered entity should submit a statement on health center letterhead addressing that fact. However, if the named provider has purchased his/her own individual professional liability medical malpractice insurance coverage, which was in effect during the allegation time period, the covered entity must provide evidence of this coverage.
11. All correspondence received from the claimant pertaining to the claim.
12. The name and telephone number of a contact at the health center familiar with the certification information requested above.
13. Three copies of all of the plaintiff’s medical records including x-rays, laboratory reports, and other results and treatments from the covered entity and any private facility that might be involved. (Note: The original medical records should be sequestered by the health center and retained until the conclusion of the case.)