U.S. Department of Health and Human Services
Indian Health Service: The Federal Health Program for American Indians and Alaska Natives
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RISK MANAGEMENT

Risk Management and Medical Liability

A Manual for Indian Health Service and Tribal Health Care Professionals
(Second Edition)
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Section Eleven: The Malpractice Tort Claim Review Process

When a medical malpractice tort claim alleging negligent care at Indian Health Service (IHS) or Tribal facilities is filed, the action is against the Federal Government. The review process involves individuals and programs from various offices within the Department of Health and Human Services (HHS). And if the tort claim becomes a suit, then the Department of Justice (DOJ) takes charge of the case. In order to better understand the process, it is first important to appreciate the responsible parties and their respective roles; subsequently, the details of the review process will be outlined.

The Department of Health and Human Services

The IHS Risk Management (RM) Program: The review and evaluation of medical malpractice tort claims is an inherent federal function that cannot be contracted, and therefore the IHS RM program processes malpractice claims arising from care provided at IHS direct care sites as well as tribally operated facilities. The Agency’s RM program is organized within the Office of Clinical and Preventive Services, IHS Headquarters, Rockville, Maryland. The complete responsibilities of this program were outlined in the first section of this Manual. Currently (2006), two physicians – one fulltime, the other halftime—are managing the program, with occasional assistance from a dentist and a Headquarters nurse administrator.

The IHS is one of the operating divisions within HHS; therefore, any administrative tort claim (malpractice, injury, or other) involving an incident at an IHS or Tribal facility becomes the responsibility of the legal arm of the HHS, the Office of the General Counsel (OGC). There are two components of the OGC that have primary responsibility for the administrative tort claim review: the OGC Claims Office and the Claims and Employment Law Branch.

The OGC Claims Office: The Claims Office was formerly separate from the OGC, both in organization and distance. Originally known as the PHS Claims Office, the program was renamed the PSC Claims Branch in 1995 when HHS underwent a phase of reorganization. More recently in 2004, this office was again reorganized and is now under the OGC “roof,” both in organization and location. Their functions and responsibilities, however, have remained basically the same. The Claims Office is primarily responsible for reviewing the validity of the claim, requesting medical records from the site of the incident, and responding to inquiries and questions about the claim. They also inquire about employment information for involved providers to determine if these providers are covered by the Federal Tort Claims Act (FTCA). The Claims Office also notifies IHS when claims are paid, and maintains a database of all claims filed against the Federal Government that involve any of the operating divisions of HHS.

The Claims and Employment Law Branch of the OGC (CELB): The CELB provides legal advice and review of all federal administrative tort claims (including medical malpractice) involving incidents at any of the facilities or programs that are part of the HHS. With respect to cases involving alleged medical malpractice, this includes the IHS, Tribal programs, the National Institutes of Health, and various healthcare delivery programs within the Health Resources and Services Administration. An attorney is assigned to each malpractice tort claim received. The assigned attorney makes his or her decision to allow or disallow the claim based on the legal validity of the claim and whether or not there was a breach in the standard of care.1 The attorney will usually discuss issues with the IHS risk manager before making a final decision regarding the claim. Depending on the amount of money involved, the OGC must communicate with the Department of Justice before agreeing to allow higher cost claims. If, after considering the facts, the law, and the medical standards involved, OGC decides that the claim is meritorious, settlement negotiations will be initiated with the claimant (or claimant’s representative). If it is determined that there is no liability on the part of the Government, the claim is disallowed.

Medical Claims Review Panel (MCRP): The original name for the MCRP was the Quality Review Panel (QRP), which was formed in 1990. The QRP was given the responsibility to review all medical malpractice claims filed against the Federal Government that involved care provided at facilities controlled or funded by various operating divisions of the HHS and determine if 1) the standard of care was met or not met, or if a system breakdown caused the outcome of the care provided to be outside the control of the involved practitioner(s), and 2) which practitioners were primarily responsible for providing the care in question. Should payment be made on a claim, it is these identified practitioners who would be subject to be named to the National Practitioner Data Bank (NPDB). According to the original HHS policy, a NPDB report was required for every case, whether or not the standard of care was met.2 The only exception was when the Panel had declared a “system breakdown.”

Cases were presented to the QRP prior to being sent to OGC for legal deliberation. Therefore, the Panel’s decision was also made available to OGC in addition to the other reviews obtained by the IHS RM Program. Over time, the Panel’s workload increased to more than 250 cases annually, following the enactment of a law that brought a wide range of federally supported health centers under the auspices of the FTCA. In 2004, the Panel was re-chartered and became the MCRP. Under this new charter, the Panel does not review every malpractice tort claim; rather, only those cases that have been allowed by the OGC or paid in the course of litigation (e.g., settled or adjudicated) are reviewed.

The MCRP consists of approximately 15 members of a variety of medical disciplines, including physicians, dentists, nurses, advanced practice nurses, and pharmacists. It is responsible for reviewing HHS malpractice tort claims from all of its operating divisions, not just IHS and Tribal programs. Meetings are held monthly; an IHS RM Program representative presents the IHS-related cases. All the reviews and supporting documents are sent to all panel members prior to the meeting. Decisions regarding the standard of care are made by majority vote after the case has been discussed. Providers of record are determined in a similar fashion, with particular reference to the responsibilities of the practitioners involved.

Department of Justice

Once a suit (civil action) against the Federal Government is filed in the appropriate U.S. Court, it is the Department of Justice (DOJ) that is responsible for defending the case. An assistant U.S. District Attorney (AUSA) within the jurisdiction is assigned the case and assisted by a Departmental attorney. The AUSA will usually seek outside expert witnesses to defend the case, obtain depositions from involved providers, and procure all private records through discovery (this discovery process is not available at the administrative claim stage). While some cases with little merit are dismissed, the majority of cases are settled before going to trial. When cases do go to trial, they are argued before a judge in the respective U.S. District Court (non-jury trial). The applicable standard of care is that which is in effect in the state in which the incident occurred.

A Step-by-step Guide to the Review Process

The following guide is provided to assist the reader’s understanding of how a tort claim is worked through the system. The first flow diagram below (Medical Claims Review Process) will help to visualize the process.

  1. A person who believes they have suffered an injury due to the negligence of an IHS/Tribal health care provider or facility must first file a tort claim with the OGC Claims Office. No attorney at this point is required, but most prospective claimants do seek legal advice. To submit the claim, a claimant may use the “Standard Form 95,” or simply state in a letter where and when the incident happened, what injury was sustained and how much compensation (in dollars) is being sought.
  2. The Claims Office requests three copies of the relevant medical records from the site of the incident. Also requested are practitioner narratives and employment information for the practitioners involved (to ascertain whether or not the involved practitioners are covered by the FTCA). Upon receipt of these documents, a copy of the records and narratives are forwarded to the IHS RM Program.
  3. When the IHS RM Program receives the tort claim and accompanying medical records from the Claims Office, the case is assigned to a Headquarters’ risk manager to coordinate the medical review of the claim. The “case coordinator” reviews the case in detail and considers the need to request any additional information through the Claims Office (e.g. outside medical records, x-rays, etc).
  4. The clinical director or risk manager at the involved site is contacted by the case coordinator to initiate a site review of the incident. Along with the site review, the coordinator asks that all providers involved in the care be notified about the claim, and be given the opportunity to respond with a practitioner narrative (if they have not already provided one) or to participate in the local review of the claim. The coordinator also requests specific practitioner identifying and credentialing information. For providers who may have left the facility, the coordinator requests the service unit send notification to that provider. While the claim is “open,” former employees do have the opportunity to participate in the analysis of the claim with respect to the care they rendered.
  5. At the same time, the case coordinator will request a peer medical review of the case from an IHS provider distant from the site in question. The coordinator identifies someone with similar training to the individual(s) involved in the case. If a particular case involves care provided by practitioners of various disciplines, then additional reviews are sought.
  6. Once the reviews and narratives are compiled, the case is sent to the OGC for legal review. If the OGC finds the case has merit, an attempt is made to negotiate a financial settlement. If the OGC finds there is no merit, the claim is disallowed.
  7. A claimant may file suit against the government in Federal District Court under the following circumstances: the OGC fails to act upon a claim within six months of receipt of the claim; the settlement offer is unacceptable to the claimant; or the claim is disallowed by the OGC, and the claimant wishes to pursue further legal action.
  8. When a suit does occur, the case becomes the responsibility of the Department of Justice. If the DOJ determines that the case is not defensible in court, then a settlement offer will be made in the best interest of the Federal Government. If the DOJ can build a b defensible case, then a trial date will be set. Rarely, a suit is dismissed altogether by a judge on technical grounds.
  9. Cases that go to trial are heard by the respective Federal District Court without a jury. The federal judge makes final judgment on the case and determines the amount of the award. The judge may also declare in his order which practitioners were, in the judge’s opinion, negligent.
  10. Information on payments of tort claims and suits is eventually sent back to the IHS RM Program. At this point the IHS coordinators will attempt to contact involved parties to inform them of the payment and help determine if additional information is available. Then, the case coordinator will present these cases to the MCRP. The MCRP determines the medical merit of the case (standard of care met, not met, or system breakdown) and the practitioners (if any) who were responsible for providing the care in question.
  11. Once a determination has been made by the MCRP, the IHS case coordinator will communicate with the IHS/Tribal site in question, send an updated Case Summary to the clinical director, and discuss with the provider(s) of record issues related to National Practitioner Data Bank reporting, if necessary.
  12. The IHS RM Program is then responsible for submitting Medical Malpractice Payment Reports (MMPR) on all appropriate cases to the NPDB. A separate MMPR is submitted for each practitioner named by the Panel for a particular case (see following section).

The service unit’s response is key to the tort claim evaluation and risk management follow-up. The site evaluation of an incident may be triggered by the event itself (e.g., sentinel event analysis), when a claimant’s attorney requests a patient’s records before a claim is filed, or in response to the IHS RM Program’s request. In any case, the local review and IHS evaluation should flow through the facility’s RM program in such a way that any lessons learned are fed back to hospital staff. The second flow diagram below (Risk Management Process—Service Unit Level) shows the dynamics of how a service unit’s process of risk management review might function.

Footnotes

1 These attorneys rely greatly on medical reviews submitted by operating division involved in each claim. See the Step-by-Step Guide to the Review Process on Page 37–38.

2 At the time this Manual was being prepared (February 2006) this particular aspect of the HHS policy was being reviewed. See Section XII for additional details on NPDB reporting.


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This flow chart portrays the malpractice claims review process at H.H.S. and I.H.S. The details of the process are described in the text.

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This flow chart describes the risk management process at the I.H.S. service unit level.

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