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Federal Register / Vol. 86, No. 115 / Thursday, June 17, 2021 / Rules and Regulations non-DoD providers, and evidence of pain and suffering or other harm.
d Substantiating the claim. Under section 2733ab6, DoD is allowed to pay a claim only if it is substantiated.
The claimant has the burden to substantiate the claim by a preponderance of the evidence. Upon receipt of a claim, DoD may require that the claimant provide additional information DoD believes is necessary for adjudication of the claim, including the submission of an expert opinion at the claimants expense. DoD may determine an expert opinion is not necessary when negligence is within the general knowledge and experience of ordinary laypersons, such as when a foreign object is unintentionally left in the body or an operation occurred on the wrong body part.
e No discovery. There is no discovery process for adjudication of claims under this Part. However, claimants may obtain copies of records in DoDs possession that are part of their personnel and medical records in accordance with DoD Instruction 5400.11, DoD Privacy and Civil Liberties Programs; DoD Instruction 6025.18, Health Insurance Portability and Accountability Act HIPAA Privacy Rule Compliance in DoD Health Care Programs, and supplemental DoD
issuances to those Instructions.
Claimants are not entitled to attorney work product, attorney client privileged communications, material that is part of a DoD Quality Assurance Program protected under 10 U.S.C. 1102, predecisional material, or other privileged information.

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45.5 Elements of payable claim: facilities and providers.

a In general. This section describes some of the necessary elements of a payable claim. The health care involved must occur in a covered military medical treatment facility MTF and be provided by a DoD health care provider acting within the scope of employment.
b Covered MTF. 1 As provided in section 2733ab3 and i1, the alleged act or omission constituting medical malpractice must have occurred in a covered MTF. For the purposes of this regulation, an MTF is a medical center, inpatient hospital, or ambulatory care center, as those facilities are described in 10 U.S.C. 1073d. Fixed dental clinics are also included.
2 A claim may not be based on health care services provided by DoD
health care providers in any other location, such as in the field, battalion aid stations, ships, planes, deployed settings, or in any other place that is not a covered MTF.

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c DoD health care provider. As provided in section 2733ai2, a DoD
health care provider is a member of the uniformed services, DoD civilian employee, or personal services contractor of the Department under 10
U.S.C. 1091 authorized by DoD to provide health care services. A nonpersonal services contractor or a volunteer working in an MTF is not a DoD health care provider for purposes of a payable claim under this part.
d Scope of employment. As provided in section 2733ab2, for a claim to be payable under this part, the DoD health care provider whose negligent or wrongful act or omission is the basis of a claim must be acting within the scope of employment, meaning that the provider was acting in furtherance of his or her duties in the MTF. For personal services contractors, scope of employment means the contractor was acting within the scope of his or her duties.
45.6 Element of payable claim: negligent or wrongful act or omission.

a In general. To establish the element of a negligent or wrongful act or omission, a member of a uniformed service claimant allegedly harmed incident to service by medical malpractice must prove by a preponderance of the evidence that one or more DoD health care providers in a covered MTF acting within the scope of employment had a professional duty to the patient involved and by act or omission breached that duty which proximately caused the injury or death.
b Standard of care. The professional duty referred to in paragraph a of this section is a duty to exercise the same degree of skill, care, and knowledge ordinarily expected of providers in the same field or specialty in a comparable clinical setting. The standard of care is determined based on generally recognized national standards, not on the standards of a particular region, State or locality. However, standard of care in the military context may be impacted by the particular setting and the availability of resources in that setting.
c Breach of the standard of care. A
breach referred to in paragraph a occurs if the health care provider or providers by act or omission did not meet the standard of care.
d Presenting evidence of the standard of care. A claimant may present evidence to support what the claimant believes is the standard of care relevant to the care involved in the claim.
e Presenting evidence of a failure to meet the standard of care. 1 A

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claimant may present evidence to support what the claimant believes demonstrates the failure of one or more DoD health care providers to meet the standard of care. That evidence may be based on the medical records of the patient involved and other documentary evidence of the acts or omissions of health care providers involved, including expert reports.
2 Evidence of an apology by a health care provider or any other DoD or Military Department personnel, such as hospital directors or commanders, to or regarding a patient will not be considered evidence of medical malpractice. Providers often apologize for unexpected or adverse outcomes independent of whether the providers acts or omissions met the standard of care.
f Information DoD will consider in assessing whether there was a negligent or wrongful act or omission. 1 In addition to the information submitted by the claimant, DoD may consider all relevant information in DoD records and information systems or otherwise available to DoD, including information prepared by or on behalf of DoD in connection with adjudication of the claim.
2 DoD will consider medical quality assurance records relevant to the health care provided to the patient. DoDs Clinical Quality Management Program features reviews of many circumstances of clinical care. Results of any such reviews of the care involved in the claim that occurred before or after the claim was filed may be considered by DoD in the adjudication of the claim. As required by 10 U.S.C. 1102, DoD
medical quality assurance records are confidential. While such records may be used by DoD, any information contained in or derived from such records may not be disclosed to the claimant.
45.7 Element of payable claim: proximate cause.

a In general. 1 In a case otherwise payable under this part, a claimant must prove by a preponderance of evidence that a negligent or wrongful act or omission by one or more DoD health care providers was the proximate cause of the harm suffered by the member.
2 Under section 2733ac1, DoD is liable for only the portion of compensable injury, loss, or damages attributable to the medical malpractice of a DoD health care provider. To the extent other causes contributed to the personal injury or death of the member, whether pre-existing, concurrent, or subsequent, the potential amount of compensation under this regulation will
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