January – March 2010

Perspective 1

MG Russell J. Czerw

The Army Physical Disability Evaluation System 5

Lakandula Duke Dorotheo, JD

Risk Management: The Role of Peer Review in Potentially Compensable 20

Event and Medical Malpractice Claims Processing

in the Army Medical Department

LTC Anthony J. Kutsch

Consent to Medical Treatment 24

Karin Waugh Zucker, JD; Martin J. Boyle, JD; COL Thomas C. Jefferson; MAJ Dennis J. Ratliff

Medical Futility 28

Mark P. Sposato, JD

Biomedical Research Involving Human Subjects 33

Stephen Maleson, JD

The Medical Affirmative Claims Program 44

Melissa W. Hartley, JD

Adverse Privileging Actions in the Army Medical Department 48

Rosalind D. Gagliano, JD

US Army Medical Command Intellectual Property 56

Elizabeth Arwine, JD; Jill Caldwell

Gifts of Travel Benefits from Nonfederal Sources to Military 62

and Civilian Government Employees

MAJ Joseph B. Topinka

Off-Duty Employment of Department of Defense Health Care Providers 68

CPT Holly Bryant

Witnesses: The Rules For Army Health Care Providers 72

CPT Ean P. White

The

Medical-Legal Partnership

in the

Army Medical Department
LTG Eric B. Schoomaker 

The Surgeon General 

Commander, US Army Medical Command 

MG Russell J. Czerw 

Commanding General 

US Army Medical Department Center and 

School 

January – March 2010 The Army Medical Department Center & School PB 8-10-1/2/3 

1006801 

GEORGE W. CASEY, JR 

General, United States Army 

Chief of Staff

DISTRIBUTION: Special 

Administrative Assistant to the 

Secretary of the Army 

By Order of the Secretary of the Army: 

Official: 

JOYCE E. MORROW 

Online issues of the AMEDD Journal are available at http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1 

A Professional Publication 

of the AMEDD Community 

The Army Medical Department Journal [ISSN 1524-0436] is published quarterly for 

The Surgeon General by the US Army Medical Department Center & School, ATTN 

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CORRESPONDENCE: Manuscripts, photographs, official unit requests to receive 

copies, and unit address changes or deletions should be sent to the Journal at the 

above address. Telephone: (210) 221-6301, DSN 471-6301 

DISCLAIMER: The Journal presents clinical and nonclinical professional information 

to expand knowledge of domestic & international military medical issues and 

technological advances; promote collaborative partnerships among Services, 

components, Corps, and specialties; convey clinical and health service support 

information; and provide a peer-reviewed, high quality, print medium to encourage 

dialogue concerning healthcare initiatives. 

Views expressed are those of the author(s) and do not necessarily reflect official US 

Army or US Army Medical Department positions, nor does the content change or 

supersede information in other Army Publications. The Journal reserves the right to edit 

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CONTENT: Content of this publication is not copyright protected. Material may be 

reprinted if credit is given to the author(s). 

OFFICIAL DISTRIBUTION: This publication is targeted to US Army Medical 

Department units and organizations, and other members of the medical community 

worldwide. 
 January – March 2010 1

MEDLINE Selects The AMEDD Journal

It is indeed my pleasure to announce that the Army 

Medical Department Journal has been selected to be 

included and indexed in MEDLINE, the National 

Library of Medicine’s bibliographic database of life 

sciences and biomedical information. As such, articles 

published in the AMEDD Journal are now indexed and 

available to researchers and writers through the 

PubMed search interface. The AMEDD Journal joins 

the ranks of the world’s finest medical science 

periodicals in the database, ensuring that the 

contributions of our dedicated military medical 

professionals are readily accessible throughout the 

global scientific and academic communities. This 

selection is the culmination of several years of work to 

elevate the AMEDD Journal to the standards of the 

National Library of Medicine, and is a major milestone 

in the continuing efforts to ensure only the highest 

quality of content is presented within Army medicine’s 

premier publication. I strongly encourage all medical 

professionals, military and civilian, to take advantage 

of this exciting opportunity to share results, 

observations, opinions, and ideas which have 

application or perspectives in military medical science. 

In the mythical ideal world, the practice of medicine 

would always be a straightforward proposition. The 

skilled practitioner applies the knowledge, experience, 

and insights gained from years of education and 

dedicated practice to address the patient’s problems. 

The patient, in turn, understands and accepts the 

limitations, complexities, and risks associated with 

medical treatment, and makes every effort to cooperate 

and assist the healthcare provider in his or her care. 

Both the caregiver and patient benefit, the former 

obtaining more experience and knowledge with which 

to pursue the practice, and the latter satisfied with the 

outcome. Of course that ideal world scenario 

presupposes that work within medical science and the 

practice of medicine are undertakings free from 

external complications and constraints. 

Unfortunately, the reality is that medical professionals, both civilian and military, pursue their 

occupations in an extraordinarily complex, intensely 

regulated, and highly litigious world. No area of 

medicine is immune, certainly not the healthcare 

providers, but also those in research, manufacturing, 

pharmacology, training, logistics, and even those who 

are responsible for the facilities that house the various 

functions of modern medical practice—and that list is 

far from complete. Such concerns and external factors 

severely complicate the application of the actual 

medical skills and training that practitioners have 

dedicated years to perfect, and too often are 

distractions to their work. 

Fortunately for those of us who work as Army medical 

professionals, there are specialized legal professionals 

of the Army Judge Advocate General (JAG) Corps 

who are our partners in navigating the labyrinth of 

overlapping, interlocking, and often obscure laws, 

regulations, rules, protocols, procedures, and 

restrictions that are involved in work in the medical 

sciences. They are an invaluable resource that is 

absolutely necessary for us to do what we should do 

best, care for the health and well-being of our Soldiers, 

their families, and our military retiree community. The 

attorneys, paralegals, and administrative personnel are 

actively involved, both directly and behind the scenes, 

in decision processes, planning, and drafting and 

publishing all manner of procedures, protocols, 

directives, and guidelines. Additionally, they provide 

consult on the myriad of issues that are encountered at 

literally every level of the Army Medical Department 

every single day. It is not exaggeration to say that the 

delivery of healthcare would be almost impossible 

without their involvement as our advisers, advocates, 

and sometimes defenders—truly our partners in our 

chosen professions. 

MAJ Joseph Topinka, the Deputy Staff Judge 

Advocate for the Army Medical Command at Fort 

Perspective Perspective

Major General Russell J. Czerw
2 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

Sam Houston, has assembled a collection of articles 

from the JAG community within Army medicine. 

These 12 articles touch some of the more important 

and often-encountered legal subjects in military 

medicine. The articles address concerns of patients, 

those of the institutions (medical commands, hospitals, 

clinics, research activities, etc), and topics of direct 

interest to healthcare providers. However, as diverse 

and complete as these articles are, they represent only 

a fraction of the many areas in which Army medicine 

relies on the knowledge and experience of the Army 

JAG Corps. 

As the level of capabilities and sophistication of 

medical science has markedly increased over the years, 

so has the ability of military medicine to save the lives 

of our wounded Warriors on the battlefield. Many 

more of the wounded survive their injuries than ever 

before in history, but sometimes with the prospect of 

living with a disability for the rest of their lives. Of 

course the military provides extensive rehabilitative 

care and resources, but many of those Warriors’ 

injuries render them unfit for continued military 

service. Mr Duke Dorotheo’s detailed, comprehensive 

article addresses the processes and participants in the 

various stages that the disabled Soldier may 

experience in the determination of his or her discharge 

from active duty, or, in some cases, retention in active 

status. This article gives great insight into the 

complexity of the structure that exists to comply with 

the Department of Defense and Army instructions, 

regulations, and directives, which themselves are 

necessary to implement the federal laws governing 

disabled military personnel. Mr Dorotheo provides a 

wealth of information useable by everyone with an 

interest in the process, including injured Soldiers 

themselves. 

Peer review is usually thought of in the context of the 

evaluation of an individual’s capabilities, conduct, or 

other aspects of professional qualifications. However, 

Army medicine employs peer review in an important 

role in risk management at medical treatment facilities 

and hospitals. Risk management peer review is 

actuated by an event that occurs during patient care 

that results in injury, the filing of a medical claim, or 

notification of payment of a claim settlement or award. 

It is an essential part of the inquiry into the facts and 

circumstances involved in the incident in question. 

LTC Anthony Kutsch’s article clearly presents a 

description of the processes, the underlying regulations 

and federal statutes, and the various possible 

outcomes. The article provides a detailed discussion 

about this extremely important component of the 

Army Medical Department’s robust quality control 

structure, which itself is an essential element in 

maintaining the high level of care that our Soldiers and 

other eligible patient populations deserve every day. 

Karin Zucker and her coauthors have contributed an 

article which explores a topic that, on the surface, 

seems simple, but in reality is a potentially 

complicated element of patient care with serious legal 

implications. Today, a patient’s consent is an obvious 

requirement before a healthcare provider may begin 

treatment, whether a simple action, a surgical 

procedure, or a complex, long-term course of 

treatments, perhaps involving extended discomfort or 

actual risk. However, it has not always been that way. 

As detailed in the article, today’s concept of informed 

consent has actually evolved over the years through a 

series of legal decisions. Although most people may 

think that they intuitively understand what it means to 

give consent to medical treatment, from a legal 

perspective nothing could be further from the truth. 

This article expands the concept into its elements and 

subelements to provide an understanding of the 

importance of addressing the smallest details of 

judging the patient’s capability to understand 

information, presenting the details of the treatment 

such that the patient can make an informed decision, 

and ensuring that decision is completely voluntary 

(free from coercion or overt influence). This is an eyeopening look at just one of the basic parts of healthcare 

delivery in which legal expertise is absolutely vital. 

At the other end of the treatment decision spectrum are 

the physician’s decisions as to whether to begin 

treatment, or to end treatment already underway, 

notwithstanding the desires of the patient or those 

legally responsible for the patient. This area involves 

the concept of medical futility. As Mark Sposato 

defines it in his article, “medical futility generally 

refers to interventions that are unlikely to produce any 

significant benefit for the patient.” Although several 

states have attempted to address this difficult decision 

area through statutes, the experience of healthcare 

providers continues to demonstrate that attempts to 

legislatively stipulate items within an area of so many 

conjectural, even hypothetical components are usually 

insufficient, and often complicate the predicament 

even further. Mr Sposato’s excellent article contains a 

number of examples and case studies demonstrating 

the twists and turns in such decision situations, and the 

Perspective 
 January – March 2010 3

THE ARMY MEDICAL DEPARTMENT JOURNAL

complications that arise as conflicting interests and 

legal actions become involved. Further, he discusses 

some of the various statutory efforts to address 

medical futility, and explains both their strong points 

and shortcomings. This is a comprehensive, very 

informative overview of this difficult subject, and is a 

“must-read” for healthcare practitioners who could 

potentially face such decisions. 

Medical research makes extensive use of computer 

models, laboratory experiments, and animal studies, 

but at some point human subjects must be involved to 

validate everything that has been learned through the 

other techniques. Unfortunately, human history 

contains far too many horrific examples of human 

experimentation that was not bound by any moral or 

ethical concerns, and was conducted on imprisoned 

subjects without regard to their welfare, sometimes 

with government sponsorship. Stephen Maleson’s 

article is a comprehensive, well researched discussion 

of the evolution of this very sensitive topic which 

bridges statutes, regulations, international agreements 

and protocols, and, perhaps most important, ethics. 

Similar to the parameters surrounding informed 

consent to treatment, the overriding principle that has 

been championed in international codes and declarations, various national protocols and guidelines, and 

codified into national laws is that researchers must 

have the voluntary, informed consent of a prospective 

subject or a subject’s legal representative before any 

experimentation may begin. Mr Maleson develops the 

topic from the historical, global perspective and moves 

into the details of the rules and regulations that apply 

for involvement of human subjects in research by US 

companies and agencies, specifically that conducted 

by Department of Defense and Army researchers. This 

article is replete with important information and 

details, and should be a valuable reference source for 

those considering or developing a research project that 

will ultimately involve human subjects. 

As we all know, military personnel, retirees, and their 

dependents are eligible for treatment at military 

medical treatment facilities, no matter the cause for the 

condition requiring treatment. However, not so wellknown is that the military may seek reimbursement for 

the costs of treatment which is necessitated by action 

of a third party (not associated with the federal 

government). Further, the government may also seek 

reimbursement of the wage costs for those service 

members unable to perform their duties due to injury 

by a nonfederal source. In her excellent article, 

Melissa Hartley describes one structure for recovery, 

the Medical Affirmative Claims Program, in detail, 

including the authorizing laws, regulations, and directives, and the various situations and conditions that apply in the process. The recovery may be from several 

avenues, depending on the circumstances involved in 

the patient’s condition. The effort required in the reimbursement recovery process is directly compensated in 

that the bulk of the recovered funds are retained by the 

facility where the care was rendered. The information 

in this article should be carefully reviewed at military 

medical treatment facilities and hospitals to ensure that 

the Medical Affirmative Claims Program is used to the 

maximum extent to recover every cost to which the 

facility may be entitled. 

One of the unfortunate realities of any profession is 

that, despite sophisticated accreditation and 

certification requirements, there will be practitioners 

of the profession who are not completely competent in 

their chosen field, for any number of reasons. The 

practice of medicine, including that within the 

military, is not immune to this problem. Rosalind 

Gagliano has contributed an important article that 

details the process by which the military monitors the 

competence of its practitioners, and the actions that are 

available to address suspected problems. A healthcare 

practitioner is granted clinical privileges to practice in 

a military medical treatment facility by the credentials 

committee, under the authority of the facility 

commander. Actions taken to limit or remove those 

privileges are called adverse privileging actions, and 

are a serious step which can sometimes mean the end 

of a career. For this reason, a considerable statutory 

and regulatory structure governs the system by which 

adverse privileging actions are initiated, processed, 

and reported. The legal and practical implications of 

any such actions are considerable, and close 

involvement of specialized legal professionals in the 

process is a must. Ms Gagliano lays out the history of 

the existing structure from the original federal 

legislation in 1986, and describes the military implementation of those requirements with Department of 

Defense and Army regulations. This article is a 

carefully constructed, clearly written, specifically 

referenced discussion of this extremely important 

aspect of quality assurance in the Army Medical 

Department. The health and safety of our Soldiers and 

all other patients in the military medical system 

depend upon unwavering attention to any indication of 

less than the best from our healthcare providers. 
4 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

The creativity, initiative, and spirit of innovation that 

exists throughout Army medicine are invaluable assets 

for maintaining the extremely high level of healthcare 

service that is provided to our Warriors throughout the 

world. Our professionals are constantly seeking ways 

to do it better, faster, and more efficiently, no matter 

what “it” may be. A search for improvement may 

result in a device, a book, or a software package that is 

applicable in both military and civilian environments. 

Such things are originally ideas, and are now 

recognized as important legal entities called 

intellectual property, with the same possible economic 

value as the physical inventions with which we are 

familiar. Army medicine formally pursues a 

considerable amount of research, representing a 

significant amount of value in intellectual property, all 

of which must be protected. Elizabeth Arwine and Jill 

Caldwell have written a very interesting and 

informative article that provides an overview of the 

many federal laws and agency regulations that govern 

the legalities involved in creating and protecting 

inventions in the course of federal employment, to 

include intellectual property. As they define and 

describe the various protections established by law, 

they also carefully frame the relationship of those 

protections to those of us who may conceive or create 

a useful item or idea as part of our job. Also, there are 

provisions for sharing in any royalties that the 

government may receive for one’s invention. This 

article is a primer for those who may be interested in 

developing an idea or device to improve their work 

efficiency or effectiveness. 

MAJ Joseph Topinka opens his article with the 

following: “Medical personnel in the US military are 

extensively educated, trained, and experienced 

professionals whose expertise is in high demand.” 

With that sentence, he defines the essence of the high 

quality level of military medicine that exists today, but 

he also sets the framework for potentially serious 

problems for those highly skilled medical 

practitioners. The “high demand” that exists for those 

individuals comes from numerous private sources: 

professional organizations, private companies, 

universities, hospitals, etc. Such entities are more than 

willing to fund the travel costs of those invited to 

various forums to share their expertise. Therein lies the 

potential for problems. Federal government employees 

may only accept travel benefits within a rigid 

framework strictly defined by several statutes and 

regulations. MAJ Topinka’s article is an excellent, 

comprehensive presentation of the various situations 

and conditions that dictate whether or not travel 

benefits may be accepted, and the approval processes 

for the types of travel that are allowed. This article 

should be made available as an easy to understand 

resource for those who may receive inquiries or 

invitations from outside organizations. 

The same professional expertise and capabilities that 

create the demand for military medical professionals at 

conferences and seminars also make them highly 

employable while off-duty. Employers recognize that a 

military healthcare provider represents the entire 

“package” of education, training, experience, skill, and 

discipline, an unquestionable value. The military does 

not prohibit such employment in most cases, but there 

are specific limitations and conditions that apply to 

these arrangements. CPT Holly Bryant’s article 

discusses the regulations and policies that govern offduty employment of military healthcare providers. The 

article categorizes the types of employment of 

concern, addresses the limitations of such 

employment, and outlines the procedures to obtain 

approval from the provider’s commander. The rules 

and requirements are specific and detailed, but are 

necessary to ensure that the potential off-duty 

employment will have no effect on the provider’s 

primary obligation—the health and well-being of the 

American Warrior. 

Another demand for military healthcare practitioners 

comes directly from the legal community. Providers 

are often sought as witnesses in litigation, but their 

participation in such a venue is conditional and highly 

regulated. CPT Ean White has provided a succinct, 

clear discussion of the types of litigation, the 

limitations of provider participation, and the approvals 

that must be obtained before an individual may 

participate. His article makes it very clear that a 

healthcare provider should immediately contact the 

military legal counsel serving the facility as soon as he 

or she is notified of the request to be a witness. Even if 

the circumstances seem straightforward and 

innocuous, unrecognized factors may make 

participation risky for the individual, both 

professionally and personally. The military legal 

counsel is there to ensure that neither the provider nor 

the military are placed in a position of embarrassment 

or financial risk. 

Perspective 
 January – March 2010 5

The Army Physical Disability 

Evaluation System 

Lakandula Duke Dorotheo, JD 

PURPOSE

This article provides a working knowledge of the 

Army’s Physical Disability Evaluation System 

(APDES) and discusses changes in the APDES 

mandated by the National Defense Authorization Act 

for Fiscal Year 2008 1 and disability-related provisions 

of the National Defense Authorization Act for Fiscal 

Year 2009.2

OVERVIEW

Chapter 61, 10 USC provides the Secretaries of the 

military departments of the United States with 

authority to retire or discharge a member if they find 

the member unfit to perform military duties because of 

physical disability. The US Army Physical Disability 

Agency (PDA), under the operational control of the 

Commander, Human Resources Command, is 

responsible for operating the Physical Disability 

Evaluation System (PDES) and executes Secretary of 

the Army decision-making authority as directed by 

Congress in Chapter 61, 10 USC. Department of 

Defense Directive 1332.18,

3 Department of Defense 

Instruction 1332.38,

4 Army Regulation 40-400,5 Army 

Regulation 40-501,

6 Army Regulation 635-40,7

 and 

Army Regulation 600-60 8 set forth the policies and 

procedures implementing the statute. The PDA is 

currently located at the Walter Reed Army Medical 

Center, Washington, DC. 

As delineated by Army Regulation 635-40, the objectives of the APDES are to maintain an effective and fit 

military organization with maximum use of available 

manpower; provide benefits for eligible Soldiers 

whose military service is terminated because of service 

connected disability; and provide prompt disability 

processing while ensuring that the rights and interests 

of the government and the Soldier are protected.7(p1)

REFERRAL INTO THE PHYSICAL DISABILITY

EVALUATION SYSTEM

The Joint Department of Defense (DoD) and 

Department of Veterans Affairs Disability Evaluation 

System Pilot Project involves a different process and is 

discussed later in this article. The next several sections 

will focus on the “legacy” disability evaluation system. 

In the legacy system, Soldiers can be referred into the 

APDES in 1 of 5 ways: 

 Medical Evaluation Board (MEB) 

 Military Occupational Specialty/Medical 

Retention Board 

 Command Directed Fitness Determination 

 Department of the Army Directed Fitness 

Determination 

 Reserve Component Nonduty-Related 

Fitness Determination 

Medical Evaluation Board 

The medical treatment facility initiates a MEB when a 

Soldier has reached “Optimum Hospital and Medical 

Treatment Benefit” and has a P3 or P4 permanent 

medical profile (see discussion on page 6).9

 The MEB 

determines if, under the provisions* of chapter 3, Army 

Regulation 40-501,

6(pp20-38) the Soldier meets Army 

retention standards for each of his or her medical 

conditions. 

The MEB will issue a Medical Evaluation Board 

Proceedings report on Department of the Army (DA) 

Form 3947 which itemizes each medical condition and 

states whether they meet or do not meet Army 

retention standards. If all medical conditions on the 

DA Form 3947 meet retention standards, the Soldier is 

returned to duty or referred for Military Occupational 

Specialty (MOS)/Medical Retention Board processing 

for possible MOS reclassification. If at least one 

condition does not meet medical retention standards, 

then the Soldier is referred to the Physical Evaluation 

Board (PEB) to determine if he or she is fit for duty. 

Please note that even though the MEB will make 

preliminary findings for each condition whether they 

*Chapter 3 of Army Regulation 40-501 provides objective 

criteria to determine the standards for medical retention for a 

number of medical conditions. 
6 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

were service incurred, existed prior to service, or if 

there was any service aggravation, under Army Regulation 635-40,

7(pp96-98) the ultimate decision whether a 

condition is compensable is reserved for the PEB.9

Additionally, under Army Regulation 635-40, the ultimate decision of a Soldier’s fitness is the province of 

the PEB and PDA. A Soldier is not automatically unfit 

because of a failure to meet Army retention standards. 

Practice Points for Medical Evaluation Boards

Report of Medical Evaluation Board Proceedings (DA 

Form 3947). All Soldiers are encouraged to consult 

with an MEB outreach counsel or Soldiers counsel 

upon receipt of their DA Form 3947 and supporting 

documentation. All medical conditions, regardless of 

severity, should be listed on the DA Form 3947 and 

analyzed by the MEB.7(pp3,96) Normally, the PEB can 

only determine if a medical condition is 

“unfitting” (preventing the Soldier from performing 

PMOS duties and/or basic soldiering skills) if they are 

listed on the form as “medically unacceptable” under 

Army Regulation 40-501.

6

 While the PEB has the 

authority to find any medical condition unfitting, they 

normally only consider those medical conditions 

which have been vetted through the MEB process as 

“medically unacceptable” in 

accordance with chapter 3, Army 

Regulation 40-501.

6(pp20-38) If the 

Soldier disagrees with the MEB, he or 

she may appeal by indicating their 

nonconcurrence on the DA Form 

3947 itself and submitting a written 

statement. The Deputy Commander 

of Clinical Services (DCCS) is obligated to consider 

the Soldier’s appeal and indicate what action has been 

taken, including confirmation of the original MEB 

findings. The DCCS is the designated authority for the 

MEB process. If a condition is missing or if a new 

condition which could likely be medically 

unacceptable arises after referral to the PEB, the 

Soldiers counsel or MEB outreach counsel should 

insist on having the case pulled back by the MEB or 

returned by the PEB. 

Physical Profile. When the Soldier is seeking disability 

retirement, it is extremely important that block 1 of the 

physical profile (DA Form 3349) lists all of the 

medically unacceptable conditions as found in the 

MEB report (DA Form 3947). In some cases the PEB 

has determined that a medical condition is not unfitting 

just because it was not addressed in the profile as 

limiting the Soldier’s abilities, even if it was addressed 

in the narrative summary and DA Form 3947 as 

medically unacceptable. Obviously, for a Soldier who 

is seeking a finding of fit, it is better to have fewer 

medical conditions listed in block 1. 

If the Soldier is seeking a finding of unfit, it is crucial 

that a permanent 3 (P3) or higher rating is assigned in 

the appropriate PULHES (see inset) category for the 

corresponding medical condition on his or her physical 

profile DA Form 3349 (top right corner).6(pp73-83) Each 

PULHES criteria is assigned a number from 1 to 4 

indicating the level of restriction. Further, each restriction is categorized as temporary or permanent. 

Level 1 indicates a high level of medical fitness, and 

level 2 indicates some medical condition or physical 

defect that may require some activity limitations but 

not so severe as to make fitness for duty questionable 

(it is important to note that P1 and P2 conditions are 

not considered unfitting by the PEB). Level 3 indicates 

one or more medical conditions or physical defects 

which may require significant duty restrictions or 

assignment limitations. Level 4 indicates one or more 

medical conditions or physical defects of such severity 

that performance of military duty 

must be drastically limited. 

Independent Physician Review. Section 

1612(a)(2)(D) of the National Defense 

Authorization Act for Fiscal Year 

2008 1

 provides Soldiers, upon 

request, a physician who is 

independent of the MEB to review the 

MEB records and provide counsel on the findings and 

recommendations.10 Further, the independent 

physician advises the Soldier on whether the findings 

of the MEB adequately reflect the complete spectrum 

of his or her injuries and illness. After review of 

findings with the assigned impartial health care 

professional, the Soldier shall be afforded an 

opportunity to request a rebuttal of the earlier MEB 

results. The Soldier, upon receipt of the independent 

medical review report, shall be afforded 7 calendar 

days to prepare a rebuttal, if appropriate, to the 

convening medical authority. 

Optimum Medical Treatment Benefit v “One Year Rule.”

Department of Defense Instruction 1332.38 defines 

“optimum hospital and medical treatment benefits” as 

the point of hospitalization or treatment when a 

The Army Physical Disability Evaluation System 

PULHES

P ‐ Physical capacity or stamina

U ‐ Upper extremities

L ‐ Lower extremities

H ‐ Hearing and ears

E ‐ Eyes

S ‐ Psychiatric
 January – March 2010 7

THE ARMY MEDICAL DEPARTMENT JOURNAL

member's progress appears to be stabilized, or when, 

following administration of essential initial medical 

treatment, a determination can be made of the patient's 

medical prognosis for capability of performing further 

duty.4(p8) Also, under the changes to Department of 

Defense Instruction 1332.38 mandated by the Under 

Secretary of Defense for Personnel and Readiness on 

October 14, 2008,10(p3) referrals for MEB processing 

will occur within one year of a diagnosis of a medical 

condition(s) that does not appear to meet medical 

retention standards. However, a referral may be earlier 

if the examiner determines that the member will not be 

capable of returning to duty within one year. The 2 

provisions sometimes conflict with each other. We 

have seen Soldiers referred into the Physical Disability 

Evaluation System even though they have not yet 

reached Optimum Hospital and Medical Treatment 

Benefit, due to the sole fact that they have been in a 

Warrior Transition Unit for more than a year. In those 

instances, we attempt to contact the medical treatment 

facility (MTF) to have the case pulled back or ask the 

PDA to return the case to the MTF. A clear case of 

lacking Optimum Hospital and Medical Treatment 

Benefit is the scheduling, after the Soldier’s referral to 

the PEB, of surgery which has the potential to keep 

him or her on active duty. 

Military Occupational Specialty/Medical 

Retention Board 

A Soldier cannot reclassify his or her MOS at an MEB 

or PEB. Military Occupational Specialty/Medical 

Retention Boards (MMRBs) are not part of the 

APDES, they are part of the US Army’s Physical 

Performance Evaluation System and operate under 

Army Regulation 600-60. That regulation stipulates 

that MMRBs only evaluate Soldiers who have been 

issued a permanent physical profile with a P3 or P4 

and whose medical conditions are medically 

acceptable.8(ppi,2-4) An MMRB referral is made by the 

Soldier’s servicing MTF when those conditions are 

met. The MMRB determines if a Soldier has the 

physical ability to satisfactorily perform their PMOS 

(primary military occupational specialty) or branch 

duties worldwide and in a field environment. The 

MMRB may take one of 4 actions when reviewing a 

case: a direct referral to an MEB/PEB, retain in 

PMOS/Branch, trial of Duty/Probationary status, or 

reclassification. To be recommended for retention, 

probation, or reclassification, Soldiers at a minimum 

must be able to perform the following common tasks: 

fire individual weapon; wear the ballistic helmet, loadcarrying equipment and protective mask; and perform 

one of the alternate aerobic events of the Army 

physical fitness test when the profile precludes the 

standard 2-mile run. If a Soldier cannot be retained in 

his or her PMOS or reclassified to another, they will 

be referred to the PEB to determine fitness for duty. 

The PEB is not bound to find MMRB-referred Soldiers 

unfit. If the MMRB refers a Soldier to the MEB, the 

MEB cannot directly return the Soldier to duty unless 

the physical profile is changed by the MTF to a P2 or 

lower. MEB outreach counsel and Soldiers counsel do 

not participate in MMRB proceedings, however, they 

can counsel Soldiers going through the process. Under 

Army Regulation 600-60, Soldiers are not entitled to 

legal counsel at MMRB proceedings.8(p11)

Command Directed Fitness for Duty Examination 

Pursuant to paragraph 5-4.c.(7)(c) of Army Regulation 

600-20,

11(p37) commanders may direct a medical 

examination at an MTF to determine a Soldier’s fitness 

for duty. This occurs when a commander questions the 

Soldier’s ability to perform his or her PMOS or branch 

duties due to a medical condition. The Soldier may or 

may not be under temporary or permanent profile. This 

examination may cause referral to the PEB if the 

findings show that the Soldier’s condition falls below 

Army retention standards. 

Headquarters, Department of the Army Directed 

Fitness Determination 

The Commander, Human Resources Command 

(HRC), upon recommendation of the Office of The 

Surgeon General, may also direct an MTF medical 

examination to determine a Soldier’s fitness for duty. 

The Commander, HRC, may also disapprove the 

MMRB’s recommendation to reclassify a Soldier’s 

PMOS and directly refer the Soldier into the MEB or 

PEB. 

Reserve Component Nonduty-Related 

Fitness Determination 

Department of Defense Directive 1332.183(p3) and 

Department of Defense Instruction 1332.38 4(p27)

address Reserve Component (RC) members pending 

separation for failure to meet medical retention 

standards completely due to medical impairments 

incurred outside of military service and involve no 

issue of aggravation while in a duty status.12 Such 

cases usually arise when a Soldier is mobilized and 
8 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

cannot deploy pursuant to a Soldier readiness 

processing medical examination. They also arise when 

RC members undergo their mandatory 5-year 

examination. If the PEB determines that the RC 

member is unfit, he or she is separated without 

entitlement to benefits. The PEB hearing is to solely 

determine fitness, not compensability. 

Practice Point for Nonduty‐Related Fitness

Determinations

In nonduty-related fitness determination cases, 

Soldiers do not undergo MEB processing (a dutyrelated process). Accordingly, the evidence file will 

include neither a DA Form 3947, narrative summary, 

nor an addendum. In these types of cases, the PEB can 

only determine fitness, as compensation is not an 

issue. However, if the PEB discovers evidence that the 

medical conditions for which the RC Soldier was 

referred for nonduty adjudication may be serviceincurred or service-aggravated, they must return the 

case to the Soldier’s RC command to evaluate the new 

evidence for possible referral into the duty-related 

MEB process. Reviewing the RC member’s civilian 

medical records is extremely important, especially if 

the treatment notes establish a service-connected 

medical condition or show no degree of restriction if 

the Soldier wants to be found fit for duty. Obtaining 

civilian job performance data from the Reservist’s 

civilian supervisors and letters supporting retention 

from their military chain of command may also help 

support a fit for duty finding. 

THE PHYSICAL EVALUATION BOARD

If a Soldier has a P3 or P4 profile and the MEB 

determines that he or she has at least one medically 

unacceptable condition, the case is forwarded to the 

PEB for adjudication. There are 3 PEB sites: Walter 

Reed Army Medical Center, Washington, DC; Brooke 

Army Medical Center, Fort Sam Houston, Texas; and 

Madigan Army Medical Center, Fort Lewis, Washington. The PEBs issue both informal and formal determinations. If a Soldier disagrees with a PEB’s informal determination, the Soldier can request a formal 

hearing with the assistance of appointed legal counsel. 

Soldiers may opt to have their own counsel of choice 

without expense to the Department of the Army. In 

addition, many veterans service organizations, such as 

the Disabled American Veterans, American Legion, 

and Paralyzed Veterans of America, offer free nonattorney representation to Warriors in Transition. 

Presiding Physical Evaluation Board Membership 

The PEB will empanel 3 members to make a 

determination in each case: Presiding Officer, Personal 

Management Officer, and Medical Member. The 

Presiding Officer and Personnel Management Officer 

for the panel will be either a DA civilian adjudication 

officer assigned to the PEB, or a field-grade officer of 

any component and of any branch, except the Army 

Medical Corps (MC). The medical member for the 

panel will be an MC officer or Army civilian 

physician, preferably with uniformed service MC 

experience. The medical member must not have served 

in any capacity as the Soldier’s physician or as a 

member of the Soldier’s MEB. If the case involves an 

RC Soldier, at least one of the PEB presiding members 

must be an RC member.7(p13)

Minority, Female, or Enlisted Board Members 

A Soldier may request that the presiding board include 

either enlisted, female, or minority members of the 

same minority group. For enlisted membership, if 

available, the enlisted PEB voting member will be 

ranked sergeant first class to sergeant major, and 

senior to the Soldier being evaluated. When enlisted 

PEB membership is provided, the PEB will increase to 

5 members, all of whom will have a vote. The fifth 

member may be enlisted or officer. Requests to 

include female, minority, or enlisted PEB membership 

must be in writing and will be granted where reasonably available. The board’s determination must include 

a statement of the Soldier’s request, and whether the 

request for PEB membership was or was not granted. 

Physical Evaluation Board Evaluation Process

The PEB determines 4 issues: 

Is the Soldier fit for duty? 

If the Soldier is unfit, are the Soldier’s unfitting 

injuries/conditions compensable? 

If the Soldier is compensable, what level of 

compensation (rating) will he or she receive? 

Are any of the soldier’s unfitting conditions combat-related or caused by an instrumentality of war? 

The Army Physical Disability Evaluation System 
 January – March 2010 9

THE ARMY MEDICAL DEPARTMENT JOURNAL

For RC nonduty-related cases (which do not undergo 

MEB processing), the PEB will only make a 

determination of fit or unfit. As stated earlier, nondutyrelated cases involve impairments incurred completely 

outside of military service and involve no issue of 

aggravation while in a duty status. In all cases, the 

PEB will issue an informal determination and, if 

requested, a formal hearing with personal appearance 

with appointed military counsel or counsel of choice. 

FIT OR UNFIT FOR DUTY

The mere fact that a Soldier has impairments that fall 

below Army medical retention standards or appear in 

the Veterans Affairs Schedule for Rating Disabilities13

does not automatically result in an unfit finding. The 

PEB makes a fitness determination based upon the 

Soldier’s performance data, such as evaluation reports, 

Army physical fitness test results, and awards. The 

PEB must make a determination in each case whether 

the Soldier is reasonably capable of accomplishing 

both basic soldiering skills and those tasks specific to 

his or her PMOS, skill level, branch, or specialty 

duties. DA Pamphlet 611-2114 provides the physical 

requirements and minimum PULHES scores for each 

MOS and branch specialty. The PEB will take into 

account a Soldier’s ability to execute basic soldiering 

skills, such as firing/carrying an M-16, road marching 

for 2 miles with a full battle load, wearing chemical 

defense equipment, performing 3-5 second rushes, and 

constructing an individual firing position. Another 

factor the PEB will consider includes the Soldier’s 

ability to take an Army physical fitness test, both 

standard and alternative aerobic events. Soldiers 

should be able to participate in at least one aerobic 

event (standard or alternate). The PEB shall take into 

account all medical conditions, whether individually or 

in combination, that render the Soldier unfit to perform 

the duties of their office, grade, rank, or rating. 

It should be noted that under a Directive-Type 

Memorandum revising Department of Defense 

Instruction 1332.38 signed on December 29, 2007, by 

David Chu, Under Secretary of Defense for Personnel 

and Readiness, the military departments can now 

consider deployability as a sole consideration when 

evaluating if a service member is fit or unfit for continued duty. This means that a Soldier who can otherwise 

perform their assigned duties, but who is nondeployable, can be found unfit. However, please note that at 

the time of this writing, the Assistant Secretary of the 

Army for Military and Reserve Affairs has yet to staff 

the memorandum for application in the Army. 

Strategies for Soldiers Seeking Fit For Duty 

Determination 

A Soldier in the MEB/PEB process who wants to be 

found fit and returned to duty can benefit from 

gathering useful evidence for the PEB. Soldiers should 

gather the following to show that they are fit: 

1. Physical profile (DA Form 3349), with as few physical 

restrictions as possible. Soldiers should review a copy of 

their most recent physical profile with their chain of 

command and their treating physician. If the Soldier 

believes that the profile is too restrictive, he or she 

should request the physician to make it less restrictive, 

if appropriate. If the doctor will not provide a less 

restrictive profile, the Soldier’s unit commander has 

the authority to write in block 20 of the profile that 

“physical condition does not prevent the Soldier from 

performing assigned and PMOS duties.” 

2. A commander’s statement supporting a finding of fit. 

The Soldier should discuss his or her desire to be 

found fit with his or her chain of command. Many 

times, unit commanders presume that an injured 

Soldier wants to be found unfit, and the commander’s 

statement reflects this belief. The Soldier who wants to 

be found fit should also execute as many PMOS duties 

and basic soldiering skills as possible to show the 

chain of command that he or she is fit for duty. A 

commander’s statement indicating that the Soldier has 

been regularly performing military duties, despite a 

physical condition, is generally very helpful for a 

finding of fit. 

3. A scorecard indicating that the Soldier recently passed 

the Army physical fitness test. The Soldier who wants to 

be found fit should take and pass the Army physical 

fitness test (APFT) in order to showcase his or her 

capabilities if the physical profile allows him or her to 

do so. If the physical profile restricts the Soldier from 

taking the APFT, the Soldier should obtain the 

approval of the chain of command prior to violating 

the profile. The APFT should be conducted to standard 

under the supervision of the Soldier’s chain of 

command. The APFT card should be completed and 

signed by the Soldier’s training NCO,a

 NCOIC,b 1SG,c

or unit commander. 

a. Noncommissioned officer 

b. Noncommissioned officer in charge 

c. 1st sergeant 
10 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

4. Noncommissioned Officer Evaluation Reports (NCOERs) 

and Officer Evaluation Reports (OERs). The Soldier should 

provide the Board with recent OERs or NCOERs, 

especially if the evaluations indicate that the Soldier 

continues to perform military duties despite his or her 

physical condition. 

5. Letters to the PEB from the Soldier’s military supervisors stating that the Soldier can perform PMOS duties, 

Basic Soldier Skills, and pass an APFT. These statements 

should also address the Soldier’s motivation, duty performance, and potential. Photos of the Soldier 

performing these duties are effective tools for supplementing written statements. 

6. Letters to the PEB from the Soldier’s supervisor at his 

or her civilian job. Service members on the Temporary 

Disabled Retired List, or Soldiers with nonduty-related 

fitness cases who want to be found fit should submit 

letters from their current or recent employers stating 

that their duty performance is not limited by their 

physical condition. This is especially helpful when the 

Soldier’s civilian occupation is similar to his or her 

military occupation. 

7. Letters to the PEB from physicians stating that the 

Soldier can perform military duties despite a condition. The 

Soldier’s treating physician may believe that the 

Soldier can perform military duties despite a physical 

condition, even if the MEB narrative summary and DA 

Form 3947 say the Soldier cannot. If so, the Soldier 

should obtain a note from his or her doctor providing 

that opinion and the reasons supporting it. The Soldier 

should also look to other health care providers as well. 

Physical therapists, chiropractors, counselors, and 

others who have been working with the Soldier for a 

long time may know the Soldier’s condition very well 

and may provide valuable information to the Board. 

8. Letters to the PEB from people who share physically 

demanding activities or intellectually challenging hobbies 

with the Soldier. Soldiers should gather letters from 

friends who perform with the Soldier in the church 

choir, the office softball team, or the friendly bowling 

league, for example, specifying that the Soldier is 

involved in physically demanding activities or 

intellectually challenging hobbies. Such statements 

may provide support that the service member can 

perform assigned military duties. 

General, Flag, and Medical Officers 

Paragraph E3.P3.4.2. of Department of Defense 

Instruction 1332.38, states: 

An officer in pay grade 0-7 or higher or a medical 

officer in any grade shall not be determined unfit 

because of physical disability if the member can be 

expected to perform satisfactorily in an assignment appropriate to his or her grade, qualifications, and experience. Thus, the inability to perform specialized duties 

or the fact the member has a condition which is cause 

for referral to a PEB is not justification for a finding of 

unfitness.4(p27)

For example, a surgeon who no longer has a steady 

nondominant hand due to left-hand carpal tunnel 

syndrome can still perform family medicine or a 

teaching function. 

Presumption of Fitness 

The disability evaluation system compensates 

disabilities when they cause or contribute to career 

termination prior to retirement. Continued performance of duty until a Soldier is approved for length of 

service retirement creates a rebuttable presumption 

that a Soldier’s medical condition has not caused 

career termination. Paragraph E3.P3.5.1. of Department of Defense Instruction 1332.38 states: 

Service members who are pending retirement at the 

time they are referred for physical disability evaluation 

enter the disability evaluation system under a rebuttable 

presumption that they are physically fit.4(p27)

A rebuttable presumption of fitness will apply in a 

Soldier’s case if the dictation of the narrative summary 

occurs after one of the following instances: 

 Soldier’s request for retirement is approved 

 Selection of officer for selective early retirement 

was approved 

 Officer is within 12 months of mandatory 

retirement due to age or length of service 

 Enlisted Soldier is within 12 months of retention 

control point and will be retirement eligible at that 

point. 

Rebuttal of the Presumption of Fitness 

The presumption of fitness rule shall be overcome 

when any of the following situations occur:4(pp27-28) 

The Army Physical Disability Evaluation System 
 January – March 2010 11

THE ARMY MEDICAL DEPARTMENT JOURNAL

 Within the presumptive period a new acute, grave 

illness or injury occurs that would prevent the 

member from performing further duty if he or she 

were not retiring. 

 Within the presumptive period a serious 

deterioration of a previously diagnosed condition, 

to include a chronic condition, occurs and the 

deterioration would preclude further duty if the 

member were not retiring. 

 The condition for which the member is referred is 

a chronic condition and the preponderance of 

evidence firmly establishes that the member was 

not performing duties befitting of either his or her 

experience in the office, grade, rank, or rating 

before entering the presumptive period. 

PHYSICAL EVALUATION BOARD LIAISON OFFICERS

The Physical Evaluation Board Liaison Officers 

(PEBLOs) are the administrative liaisons between 

Warriors in Transition* and the MEB/PEB processes. 

The PEBLO works under the patient administration

division at each medical treatment facility. Despite 

their name, PEBLOs are US Army Medical Command 

personnel and are neither PEB nor PDA assets. They 

are not attorneys, however, they counsel Soldiers 

undergoing physical disability processing. PEBLOs 

also serve as the point of contact between Soldiers and 

MEB members, the Deputy Commander of Clinical 

Services (DCCS), PEB members, and the PDA 

adjudicators. PEBLOs collect and prepare Soldiers’ 

MEB packets for presentation to the PEB. A Soldier’s 

MEB packet consists of medical and nonmedical 

evidence, both administrative and performance data, to 

assist PEB members in the adjudication of their case. 

PEBLOs are available to provide counseling to 

Warriors in Transition from the time they are referred 

for MEB processing through the time they are 

separated from military service. PEBLOs will work 

with Soldiers counsel, primary care physicians, PEB 

members, and nurse case managers to obtain required 

documentation and other medical information. 

COMPENSABILITY

Generally, a condition is compensable when it was 

either incurred in the line of duty or permanently 

aggravated by military service. Factors affecting 

compensability include conditions existing prior to 

service, misconduct, noncompliance with prescribed 

medical treatment, and conditions not constituting a 

physical disability. 

Condition Existing Prior to Service 

All Soldiers on active duty orders more than 30 days 

with at least 8 years of equivalent active duty service 

will overcome any finding that a current medical 

condition was not caused nor aggravated by the Army 

and is solely the result of the natural progression of a 

condition that existed prior to service (EPTS).4(p32)

Unless a medical condition is noted at the time of 

entry, all Soldiers have the presumption of soundness 

upon entry into military service.4(p32) Stated another 

way, all conditions are presumed to originate while on 

active duty. Even when it can be shown that a medical 

condition did exist prior to military service, all EPTS 

conditions are presumed service-aggravated. The presumption of soundness upon entry into military service 

and the presumption of service aggravation are rebuttable presumptions. Both National Defense Authorization Acts 081

 and 092 modified the compensability 

rules regarding EPTS conditions and elevated the 

PEB’s evidentiary burden of proof necessary to rebut 

both presumptions and deny compensation. In order to 

deny compensation due to EPTS without service aggravation, the PEB must show by “clear and unmistakable evidence” that both the disability existed before the member's entrance on active duty and the 

disability was not aggravated by active military 

service.10(p6)

Misconduct 

The PEB may also determine that a condition is 

noncompensable if the injury was caused by the 

Soldier’s own misconduct.4(p32) In those cases, a formal 

line of duty investigation is required before 

compensability is denied. 

Failure to Follow Prescribed Medical Treatment 

Under paragraph B-3, Appendix 3 of Army Regulation 

635-40,

7(p66) the PEB may deny or reduce 

compensation for Soldiers who fail to comply with 

prescribed medical treatment. The Army will not 

compensate the portion of disability that results if a 

Soldier unreasonably fails or refuses to take prescribed 

*For detailed discussions of the structure and processes of the Warriors in Transition program, see the January–March 2008 

issue of the Army Medical Department Journal, available at http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1.
12 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

medications; submit to medical or surgical treatment 

or therapy; or observe prescribed restrictions on diet, 

activities, or the use of alcohol, drugs, or tobacco. 

This reduction or denial of compensation can only 

occur if the Soldier was clearly and understandably 

advised of the proper medical course of treatment, and 

the Soldier’s failure or refusal was willful or negligent 

and not the result of mental disease or a physical 

inability to comply. 

Conditions not Constituting a Physical Disability 

The DoD has determined that the conditions presented 

in the Table do not constitute a compensable physical 

disability.4(pp72-73)

Rating and Level of Compensation 

Once the PEB determines a Soldier is unfit and 

compensable, the PEB assigns a disability rating 

percentage for each unfitting condition, according to 

the present degree of severity, based upon the Veterans 

Affairs Schedule for Rating Disabilities (VASRD).13

In situations where a certain medical impairment is not 

listed in the VASRD, the PEB will apply an analogous 

VASRD code which most closely resembles the Soldier’s condition. If a case involves 2 or more ratable 

conditions, the PEB will use a mathematical formula 

to determine the overall combined rating.7(pp67-68) The 

mathematical formula is commonly referred to by 

practitioners as “fuzzy math.” 

Section 1642 of the National Defense Authorization 

Act 081

 states that the service secretaries shall, to the 

extent feasible, only use the criteria in the VASRD to 

rate compensable disabilities, including any applicable 

interpretations by the United States Court of Appeals 

for Veterans Claims. Further, service secretaries can 

only deviate from the rating criteria in the VASRD if 

the use of such criteria will result in a determination of 

a greater percentage of disability than would be otherwise determined through utilization of the VASRD.15 

Determination of Tax Free Benefits 

For both severance and disability retirement, the PEB 

will determine that a Soldier is entitled to tax exempt 

benefits only when their unfitting injuries are combat 

related, incurred as a direct result of armed conflict, or 

caused by an instrumentality of 

war. Soldiers are also entitled to 

tax exempt benefits if, on 

September 24, 1975, they were a 

member or obligated to become a 

member of an armed force or 

reserve (of any nation), National 

Oceanic and Atmospheric Administration, or US Public Health 

Service.4(p36) The PEB will normally require command corroboration if a Soldier is asserting 

combat related or instrumentality 

of war injuries. However, the PEB 

may accept Purple Heart citations, 

Combat Infantry Badges, or 

Combat Action Badges in lieu of 

c o m m a n d c o r r o b o r a t i o n , 

depending on the nature of a 

Soldier’s specific injury. 

INFORMAL PHYSICAL EVALUATION

BOARD DECISION

Each case is first considered by an informal, 3-member 

PEB panel that issues an informal decision on the DA 

Form 199. An informal decision is based solely upon a 

paper review of the case, including the Soldier’s 

service medical record, the MEB report, any narrative 

summaries, available civilian and veterans affairs 

medical records, and any relevant service performance 

data (evaluation reports, commander’s letters, APFT 

scorecards). 

The Army Physical Disability Evaluation System 

Conditions which do not constitute a compensable physical disability as determined 

by the Department of Defense. 

*Glucose-6-phosphate dehydrogenase

Enuresis 

Sleepwalking and/or somnambulism 

Dyslexia and other learning disorders 

Attention deficit hyperactivity disorder 

Stammering or stuttering 

Incapacitating fear of flying confirmed by 

a psychiatric evaluation 

Airsickness, motion, and/or travel 

sickness 

Phobic fear of air, sea, and submarine 

modes of transportation 

Uncomplicated alcoholism or other 

substance use disorder 

Personality disorders 

Mental retardation 

Adjustment disorders 

Impulse control disorders 

Sexual gender and identity disorders, 

including sexual dysfunctions and 

paraphilias 

Factitious disorder 

Obesity 

Overheight 

Psuedofolliculitis barbae of the face and/

or neck 

Medical contraindication to the 

a d m i n i s t r a t i o n o f r e q u i r e d 

immunizations significant allergic 

reaction to stinging insect venom 

Unsanitary habits including repeated 

venereal disease infections 

Certain anemias (in the absence of 

unfitting sequelae) including G6PD* 

deficiency, other inherited anemia 

traits and Von Willebrand’s disease 

Allergy to uniform clothing 

Homosexuality 
 January – March 2010 13

THE ARMY MEDICAL DEPARTMENT JOURNAL

The PEB can issue the following dispositions: 

1. Return to medical treatment facility. The PEB can 

return a case to the MTF if it determines that the 

Soldier has not yet reached maximum medical benefit 

or if additional medical evidence is required to 

adjudicate the case. 

2. Fit for duty. Soldiers with medical conditions that 

do not prevent them from reasonably performing 

military duties, including primary military 

occupational specialty duties, basic soldiering skills, 

passing an APFT, and deploying will be found fit and 

retained in the Army. 

3. Unfit, separation without benefits. If a Soldier’s 

illness or injury is determined to be noncompensable, 

he or she will be discharged without entitlement to 

disability benefits. 

4. Unfit, separation with severance pay. Unfit Soldiers with less than 20 years of active federal service 

and who have compensable conditions with a 

combined rating of 0% to 20%, will be separated from 

the Army with severance pay. Severance pay is 

calculated by 2×(monthly base pay)×(years of active 

duty service). For RC Soldiers, active federal service is 

computed by dividing the total number of active duty 

points by 365. A Soldier may elect length of service 

retirement in lieu of severance pay if he or she is 

otherwise entitled to length of service retirement. 

Severance or Retirement Pay Decisions 

Minimum Severance Pay Provisions under National Defense

Authorization Act 08

Section 1646 of the National Defense Authorization 

Act 081

 revises the calculation of disability severance 

pay for those Soldiers who are found unfit, but do not 

meet the criteria for disability retirement. The new law 

provides that the minimum number of years used to 

calculate severance pay shall be 6 years for those 

injured in a declared tax-free combat zone or during 

combat related operations, and 3 years for all others. In 

addition, the Act increased the maximum number of 

years calculable for severance pay from 12 to 19 years. 

Service of 6 months is rounded up, and service of less 

than 6 months is rounded down. The effective date for 

this provision is January 28, 2008. 

No Department of Veterans Affairs Offset in Severance Pay

for Combat Zone Incurred Conditions

Section 1646(b) of the National Defense Authorization 

Act 081

 states that the Department of Veterans Affairs 

will not deduct severance pay received by a service 

member for unfitting line of duty disabilities incurred 

in a combat zone or incurred during the performance 

of duty in combat-related operations. The effective 

date for this section is January 28, 2008. 

Unfit, Permanent Disability Retirement

Soldiers will be permanently retired for disability 

when their conditions are permanent and stable, and 

either the combined rating is 30% or higher or they 

have at least 20 years of active duty service. Permanent Disability Retirement (PDR) entitles Soldiers 

to all the benefits of a length of service retirement. 

Retirement pay is calculated by multiplying the 

combined rating by the Soldier’s monthly base pay. By 

law, Soldiers cannot receive more than 75% of their 

monthly base pay for disability retirement. For example, an unfit Soldier with a combined rating of 100% 

can, statutorily, only receive a maximum of 75% of his 

or her monthly base pay. A Soldier may elect length of 

service retirement in lieu of PDR if the Soldier is 

otherwise entitled to a length of service retirement. 

Unfit, Temporary Disability Retirement List

Soldiers will be placed on the Temporary Disability 

Retirement List (TDRL) when their conditions are 

unstable and their combined rating is 30% or higher, or 

they have at least 20 years of active duty service. A 

Soldier on the TDRL receives all the benefits of length 

of service retirement, including retirement pay. A 

Soldier on the TDRL with a combined rating of 50% 

or less receives retirement pay equal to 50% of the 

Soldier’s active duty base pay. A Soldier on the TDRL 

with a combined rating of 60% or higher receives that 

percentage of base pay to a maximum of 75%. As 

discussed above, Soldiers cannot receive more than 

75% of their monthly base pay for retirement. By law, 

Soldiers placed on the TDRL must undergo a periodic 

18-month reevaluation by the PEB, with the exception 

of Soldiers found unfit by reason of post traumatic 

stress disorder (PTSD). Soldiers found unfit due to 

PTSD and placed on the TDRL will have a mandatory 

6-month review.4(p19) Soldiers with unfitting PTSD 

may receive PDR rather than TDR only if they have an 

80% or greater rating for non-PTSD related conditions. 

Qualified Soldiers can stay on the TDRL for a 

maximum of 5 years, however, there is no entitlement 

for a Soldier to stay on the TDRL for the entire period. 

The final disposition of TDRL cases may be fit for 

duty, separation with severance pay, separation 
14 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

without entitlement to disability benefits, or permanent 

disability retirement. A TDRL member found fit for 

duty upon periodic reexamination by the PEB will be 

given the option to separate without entitlement to 

disability benefits and not be required to complete the 

balance of their active duty or reserve service obligation.7(pp47-48) Therefore, completion of any remaining 

obligation is subject to the TDRL member’s consent. 

Election Period and Rebuttals to the Informal 

Decision 

All Soldiers are encouraged to consult with an MEB 

outreach counsel or Soldiers counsel upon receipt of 

their DA Form 199. Generally, Soldiers have 10 days 

upon receipt of their informal PEB decision to file an 

election in their case, either concur, do not concur, or 

do not concur and submit a rebuttal. A Soldier can also 

demand a formal hearing with a personal appearance, 

or a formal hearing without a personal appearance. 

Additionally, Soldiers are entitled to assistance with 

their appeal by a regularly appointed Soldiers counsel. 

The Soldier may elect to have counsel of his or her 

own choice at no expense to the government. 

Unless a Soldier obtains new medical evidence during 

their informal PEB election period or can show clear 

error on their informal DA Form 199, we suggest Soldiers elect “do not concur” and refrain from submitting 

a rebuttal at that time. Once an assigned Soldiers 

counsel has had an opportunity to review the service 

medical record, he or she can later submit a rebuttal 

statement with supporting evidence at any time prior to 

a hearing. The PEB can then issue a favorable informal 

reconsideration without the need for a hearing. 

Even if a Soldier is unable to obtain new evidence or 

show clear error, we generally suggest that all Soldiers 

initially nonconcur with their informal PEB decision 

and request a formal hearing. Such a request can be 

waived later. Assigned Soldiers counsel are provided 

the same MEB/PEB evidence packet as the board 

members, as well as access to their client’s entire service medical record. Soldiers counsel will review this 

evidence along with the Soldier’s goals to determine if 

proceeding forward with a formal hearing is advisable. 

FORMAL HEARINGS

Formal hearings are held de novo, the PEB is not 

bound by its previous decisions and recommendations. 

In addition, neither military nor federal rules of evidence are applied to PEB adjudication. The only standard for submission of evidence is that material submitted to the PEB must be relevant and material to the 

Soldier’s case. Formal hearings are nonadversarial as 

there is not an opposing counsel representing the PEB. 

On the day of the scheduled hearing, it is customary 

for Soldiers counsel to have a prehearing conference 

with the presiding PEB board members. The counsel 

will briefly discuss the merits of their case. Many 

times this informal discussion will lead to a revised 

reconsideration in favor of the client. If a hearing is 

still necessary, both counsel and client will appear 

before the board for a formal presentation of the case. 

During the hearing, the Soldiers counsel makes 

opening statements highlighting the supporting 

evidence in their case, performs the initial direct 

examination, asks any necessary redirect questions 

after the board members have exhausted their line of 

questioning, and provides a summation of relevant 

regulations, evidence, and client testimony. The 

Soldier will have an opportunity to make a statement 

just prior to the board’s adjournment for deliberations. 

Soldiers are entitled to call witnesses to support their 

case, however, they must be relevant and material to 

the issues or facts in contention. 

CONTINUATION ON ACTIVE DUTY OR ACTIVE RESERVE

FOR UNFIT SOLDIERS

Soldiers who are determined unfit may continue, if 

approved, in a limited duty status in their respective 

active or reserve component.7(p40-46) Continuation on 

Active Duty (COAD) and Continuation on Active 

Reserve (COAR) offer Soldiers the opportunity to 

continue their military careers and/or possibly qualify 

for length of service retirement in lieu of disability 

severance or retirement. 

In order for a Soldier to ensure that he or she is 

considered for COAD or COAR, the Soldier must 

request consideration in writing. Requests should be 

provided to the Soldier’s PEBLO or Soldiers counsel 

for inclusion in the PEB file. If the Soldier is found 

unfit by the PEB, the COAD or COAR request will be 

forwarded to the appropriate approving authority for 

action before the Soldier is discharged. COAD and 

COAR requests are approved and disapproved at the 

highest levels, either at the Army Human Resources 

Command or at the National Guard Bureau. 

The Army Physical Disability Evaluation System 
 January – March 2010 15

THE ARMY MEDICAL DEPARTMENT JOURNAL

Soldiers must meet one of 3 criteria to qualify for 

COAD or COAR consideration: 

At least 15 years of active federal service for 

COAD or at least 15 years of qualifying service 

for nonregular retirement (ie, “good years” in the 

Guard or Reserve) for COAR 

Qualified in a critical skill or shortage MOS 

Disability is the result of combat or terrorism 

A Soldier who qualifies for consideration will not 

necessarily be approved for COAD or COAR. Consideration criteria include disability that is not the 

result of misconduct or willful neglect, or is not incurred while absent without leave; whether the Soldier is 

capable of working in a normal military environment 

without adversely affecting the Soldier’s or other’s 

health or requiring undue loss of time from duty for 

medical treatment; and whether the Soldier is physically capable of performing useful duty in the MOS 

for which he or she is currently qualified or is potentially trainable. 

Requests for COAD or COAR do not require supporting documentation. However, in order to bolster a 

request, a Soldier may attach documents such as 

statements from commanders or supervisors 

addressing the Soldier’s physical capabilities and 

requesting that the Soldier’s request be approved, and 

letters from treating physicians addressing the 

Soldier’s physical capabilities. Indeed, any evidence 

which would support a finding of fit should be 

attached to the COAD or COAR request. 

A COAD or COAR may help Soldiers with significant 

investments in military careers by allowing those 

Soldiers to continue military service until they are 

qualified for length of service retirement (20 years). 

Soldiers with over 15 years of military service who 

may be discharged because of disability should 

strongly consider submitting a request. Soldiers with 

between 18 and 20 years of military service who do 

not request a COAD or COAR must submit a 

statement specifically declining COAD or COAR. As 

an alternative, the Soldier’s PEBLO may submit a 

statement that the Soldier was counseled and declined 

to request a COAD or COAR. COAD or COAR 

denials for Soldiers with at least 18 active duty years 

or 18 good years toward reserve retirement require 

Secretary of the Army approval. 

APPEAL OF FORMAL PHYSICAL EVALUATION BOARD

DECISIONS WHILE ON ACTIVE DUTY

If a Soldier disagrees with the formal PEB decision, 

there is generally a 10-day election period to submit a 

rebuttal. If the rebuttal is submitted within the prescribed election period, the PEB will review the rebuttal and may issue a revised reconsideration in favor of 

the Soldier. If received after the 10-day election 

period, the PEB will forward the case to the Physical 

Disability Agency (PDA) for appellate review. Under 

current policy, the Army PDA will generally accept a 

rebuttal outside of the 10-day election period only if a 

Soldier has not yet received their final transition 

processing orders. The PDA can concur with the PEB 

decision, nonconcur and modify/reverse the PEB 

decision, or return the case to the PEB in its entirety. 

The PDA designates certain cases for “own 

motion” (mandatory) review. Currently, the PDA 

reviews all cases awarded tax-free benefits due to 

combat-related disabilities in addition to all cases 

involving post traumatic stress disorder and traumatic 

brain injuries. Further, the PDA conducts a statistical 

sample review of all other cases for quality assurance 

purposes. The PDA’s own motion review can result in 

an adverse modification of a Soldier’s PEB decision. 

The Army Physical Disability Appeals Board 

(APDAB) is another level of appellate review 

potentially available to Soldiers prior to separation. 

Unfortunately, the majority of Soldiers are denied 

access to this appellate body for procedural reasons. 

By regulation, Soldiers can only file an APDAB 

appeal if the PDA modifies or reverses the PEB 

decision, creating a discrepancy between the PEB and 

PDA. However, experience has shown that the PDA, 

rather than issuing a decision inconsistent with the 

PEB, returns the case to the PEB with a 

recommendation to issue a new decision consistent 

with the PDA’s interpretation of the case. This process 

results in parity amongst the PEB and PDA’s decisions 

and, ultimately, the Soldier’s inability to file an appeal 

through APDAB. The PDA has acknowledged this 

potential for unfairness. Though not required by 

current regulations, under internal policy set by the 

current PDA leadership, Soldiers are granted access to 

APDAB if the PDA remands a case to the PEB, which 

then subsequently modifies the earlier PEB decision 

adverse to the Soldier's interests.
16 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

If an APDAB appeal is unsuccessful, the Soldier can 

then appeal PEB/PDA action after separation from 

active duty as discussed below. 

APPEAL OF PHYSICAL EVALUATION BOARD OR

PHYSICAL DISABILITY AGENCY DETERMINATIONS

AFTER SEPARATION OR RETIREMENT

After separation, retired and former Soldiers may seek 

review of their PEB or PDA determinations through 

the Army Board for Correction of Military Records 

(ABCMR), Army Disability Rating Review Board 

(ADRRB), or the newly created DoD Physical 

Disability Review Board (DoD PDRB). ABCMR 

claims must be filed within 3 years of the first 

knowledge of an error or injustice and after the former 

Soldier has exhausted all administrative remedies 

offered by existing laws and regulations. The ADRRB 

reviews disability percentage ratings upon request for 

Soldiers who were retired due to physical disability. 

Requests for ADRRB review must be made within 5 

years from the date of retirement. 

Section 1643 of the National Defense Authorization 

Act 081

 established the DoD PDRB. The PDRB will 

evaluate cases upon request of a Soldier or through its 

own motion review where the Soldier was separated 

with a 20% or less disability rating and was not 

eligible for retirement. Only Soldiers separated 

between September 11, 2001, and December 31, 2009, 

are eligible for this review. The PDRB will consist of a 

3-member panel and will make recommendations to 

the appropriate service secretary. The PDRB can make 

the following findings: 

 Recommendation for no change or modification in 

disposition 

 Recommendation that separation be recharacterized as retirement 

 Recommendation for the modification of a disability rating (however, the PDRB is barred from 

recommending a modification of the disability that 

would reduce the Rating for that disability) 

 Recommendation for the issuance of a new disability rating. 

Upon receipt of the PDRB recommendations, the 

service secretary may modify the records of the 

individual effective the date of the original PEB. 

Department of Defense Instruction 6040.44 designates 

the US Air Force as the lead DoD component for the 

establishment, operation, and management of the 

PDRB for DoD. The PDRB will only conduct a paper 

review of cases and will not hold in-person hearings. 

Initially, Department of Defense Instruction 6040.44

(2008) stated that the PDRB will only review the 

dispositions of medical conditions previously 

determined unfitting by the military department PEB. 

However, under the change incorporated in June 2009, 

the PDRB is allowed to review all medical conditions, 

not just those earlier found unfitting.16(pp1-2) Appellants 

must carefully choose their forum as DoD PDRB 

appellants may not seek subsequent nor concurrent 

relief from the ABCMR on the same issue. Further, the 

PDRB will not review any appeals that were 

previously adjudicated by the ABCMR on the same 

issue, with the exception of ABCMR claims filed prior 

to June 27, 2008 (the original effective date of 

Department of Defense Instruction 6040.44). 

Prior to the June 6, 2009, modification to the 

Department of Defense Instruction 6040.44,

16 if the 

contested separation occurred prior to January 28, 

2008 (the date the Defense Authorization Act 08 1 was 

signed into law), the PDRB would have conducted 

reviews in accordance with the Veterans Affairs 

Schedule for Rating Disabilities (VASRD) in effect at 

the time of separation, Department of Defense 

Instruction 1332.39* and any other applicable service 

regulations in affect at the time of the contested separation. This has since been changed. The DoD PDRB 

will ignore any DoD and service regulations that were 

inconsistent with the VASRD in effect at the time of 

the adjudication. This is a significant change as many 

of the older DoD and service-specific regulations were 

inconsistent with the VASRD, yielding lower ratings. 

JOINT DEPARTMENT OF DEFENSE/DEPARTMENT OF

VETERANS AFFAIRS DISABILITY EVALUATION SYSTEM

PILOT PROJECT

On November 26, 2007, the Department of Defense 

and Department of Veterans Affairs (DVA) 

implemented the Disability Evaluation System (DES) 

Pilot17,18 for disability cases originating at the 3 major 

military treatment facilities in the National Capitol 

The Army Physical Disability Evaluation System 

*Department of Defense Instruction 1332.39: Application of 

the Veterans Administration Schedule for Rating Disabilities. 

Cancelled, no longer in effect.
 January – March 2010 17

THE ARMY MEDICAL DEPARTMENT JOURNAL

Region: Walter Reed Army Medical Center, National 

Naval Medical Center, and Malcolm Grow Medical 

Center (USAF). On September 25, 2008, the Deputy 

Secretary of Defense and the Deputy Secretary of 

Veterans Affairs approved the expansion of the DES 

Pilot to 19 military installations, including 9 Army 

posts: Fort Meade, Maryland; Fort Belvoir, Virginia; 

Fort Stewart, Georgia; Fort Polk, Louisiana; Fort 

Richardson and Fort Wainwright, Alaska; Fort Drum, 

New York; Fort Carson, Colorado; and Brooke Army 

Medical Center, Fort Sam Houston, Texas. In 

November 2009, a further expansion of the program to 

6 additional installations was announced, including 

Fort Benning, Georgia; Fort Bragg, North Carolina; 

Fort Hood, Texas; Fort Lewis, Washington; and Fort 

Riley, Kansas. 

Key features of the developing DoD/DVA DES Pilot 

include a single comprehensive medical examination 

and a single-sourced disability rating. The DVA will 

conduct a single comprehensive exam and will rate all 

medical conditions. The military departments will 

accept the DVA rating for all medical conditions 

determined unfitting for continued military service 

unless the condition involves noncompliance, 

misconduct, or a nonservice aggravated medical 

condition which existed prior to service. The military 

retains authority to determine if a portion of a 

Soldier’s disability, or its entirety, is a result of an 

EPTS condition, misconduct, or noncompliance. 

Soldiers counsel will continue to provide services at all 

steps throughout the DoD/DVA DES Pilot until 

separation from active duty. 

Once a Soldier receives a permanent P3 profile and 

achieves maximum medical benefit, he or she is referred for MEB processing. During MEB processing, the 

Soldier will undergo a comprehensive physical examination conducted by the DVA. An Army physician 

will then review the DVA exams along with the 

Soldier’s service medical records to determine if he or 

she has any conditions that fall below Army retention 

standards. The Army physician will then issue an 

MEB report. If even one condition falls below Army 

retention standards or is medically unacceptable, the 

Soldier will be referred for PEB adjudication to determine if the Soldier is fit for continued duty for each 

condition falling below medical retention standards. 

Cases referred by the MEB will first be informally 

adjudicated by the PEB to determine fitness. The PEB 

will consider the Soldier’s MEB report, the DVA’s 

comprehensive exam, as well as the Soldier’s 

commander’s statement, profile, recent APFTs, and 

other performance and personnel documents. The PEB 

determines which conditions are unfitting; which 

unfitting conditions are compensable; and whether any 

unfitting compensable conditions are combat-related 

or occurred in a declared tax-free combat zone. The 

PEB’s informal findings will be documented on a DA 

Form 199 and be provided to the Soldier. The Soldier 

may elect to either concur with the informal findings 

of fitness, or nonconcur and also request a formal 

hearing with representation by Soldiers counsel. Alternatively, the Soldier can elect to have a representative 

of his or her own choice at no expense to the 

government. If the Soldier is determined unfit, he or 

she may elect to postpone concurrence or nonconcurrence until receipt of the DVA ratings. If the Soldier does not concur with the fitness determination, 

Soldiers counsel can help the Soldier identify and 

gather evidence which might support the accomplishment of their goals. Soldiers counsel may also 

present this evidence to the PEB on the Soldier’s 

behalf, along with oral arguments during the formal 

hearing, if elected. 

Soldiers can concur with the PEB’s informal fitness 

determination and nonconcur with the DVA rating. 

Soldiers can also concur with the DVA rating and 

request a formal hearing to contest the PEB’s fitness 

determination. 

All Soldiers determined unfit have a one-time opportunity to appeal their DVA rating, which the Army will 

accept for disposition purposes (severance versus 

disability retirement). This one-time rating reconsideration must occur prior to the Soldier’s separation. Any 

successful DVA appeals the Veteran makes after separation will not be accepted for military disposition 

purposes unless the DVA appeal (notice of disagreement) was filed within 1 year of separation. In addition, if the postseparation appeal is successful, the Veteran must file a claim to change his or her military 

disposition through the Army Board for Correction of 

Military Records. 

Soldiers counsel can assist service members with 

reconsideration requests regarding their initial DVA 

ratings prior to their separation from military service. 

The request for reconsideration is a paper review by a 
18 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

DVA Decision Review Officer (DRO). Soldiers are 

not afforded an in-person DVA hearing to contest their 

rating. Further, the DVA DRO will only reconsider 

evaluations of ratings if new medical evidence is 

received, or if there is evidence of an error sufficient to 

warrant reconsideration. 

CONCLUSION

Soldiers are best served by MEB outreach counsel and 

Soldiers counsel who handle physical disability cases 

on a daily basis. Many factors impact a Soldier’s 

disposition in the Army Physical Disability Evaluation 

System. There are specific evidence-driven strategies 

involved with trying to accomplish a Soldier’s goal of 

either continuing his or her military career or 

maximizing the disability rating. It is important to note 

that MEB outreach counsel and Soldiers counsel 

represent Soldiers. They do not advise or represent 

commanders, nor do they advise or represent the 

MEB/PEB. The PEB and the PDA are components of 

the Army Human Resources Command and fall under 

a different chain of command. Accordingly, neither the 

PEB nor PDA rate Soldiers Counsel performance for 

officer or civilian evaluation purposes. 

MEB outreach counsel and Soldiers counsel stand 

ready to assist Soldiers throughout the Army Physical 

Disability Evaluation System. Offices of Soldiers 

counsel are located at the Walter Reed Army Medical 

Center, Madigan Army Medical Center, Brooke Army 

Medical Center, Evans Army Hospital at Fort Carson, 

Tripler Army Medical Center in Hawaii, Darnall Army 

Medical Center at Fort Hood, Landstuhl Regional 

Medical Center and the Bavaria Warrior Transition 

Unit (Germany). 

POINTS OF CONTACT

Office of Soldiers Counsel 

Walter Reed Army Medical Center 

(202) 782-1550 

Email: soldierscounsel@amedd.army.mil 

Landstuhl Regional Medical Center, Germany 

DSN 314-486-6049 Comm: 011-49-6371-866049 

Bavaria, Germany Warrior Transition Unit 

DSN: 476-3358 Comm: 011-49-9662-83-3358 

Fort Lewis, Washington 

(253) 968-4441/4442 

Email: max.peb@amedd.army.mil 

Tripler Army Medical Center, Hawaii 

(719) 526-5572 

Fort Carson, Colorado 

(719) 526-5572 

Fort Sam Houston, Texas 

(210) 221-9392 or (210) 295-0432 

Fort Hood, Texas 

(254) 287-8887 

Offices of MEB Outreach Counsel and Warrior 

Transition Legal Assistance 

Collocated with Warrior Transition Units at the 

medical facilities at the following Army installations: 

ACKNOWLEDGMENTS

Special thanks to CPT Robert E. Webb, Jr, and MAJ 

David C. White, authors of “Physical Disability 

Separation,” published in the 1999 US Army Medical 

Command Legal Deskbook, and Ms Frances Dennis, 

Policy Advisor of the Physical Disability Agency and 

author of the “Information Paper: Overview of PDES,” 

dated April 11, 2007, for providing a useful framework 

and knowledge used in writing this article. 

REFERENCES

1. Pub L No. 110-181, 122 Stat 3 (2008). 

2. Pub L No. 110-417, 122 Stat 4617 (2008). 

3. Department of Defense Directive 1332.18: Separation or Retirement for Physical Disability. Washington, DC: US Dept of the Army; November 4, 1996. 

4. Department of Defense Instruction 1332.38: Physical 

Disability Evaluation. [Change 1]. Washington, DC: 

US Dept of Defense; July 10, 2006. 

5. Army Regulation 40-400: Patient Administration. 

Washington, DC: US Dept of the Army; February 6, 

2008. 

6. Army Regulation 40-501: Standards of Medical 

Fitness. Washington, DC: US Dept of the Army; 

December 14, 2007 [revised September 10, 2008]. 

The Army Physical Disability Evaluation System 

Ft Benning 

Ft Bliss 

Ft Bragg 

Ft Campbell 

Ft Drum 

Ft Gordon 

Ft Hood 

Ft Knox 

Ft Lewis 

Ft Polk 

Ft Richardson 

Ft Riley 

Ft Sam Houston 

Ft Stewart 

Heidelberg 

Tripler Army 

Medical Center 

Walter Reed Army 

Medical Center 
 January – March 2010 19

THE ARMY MEDICAL DEPARTMENT JOURNAL

7. Army Regulation 635-40: Physical Evaluation for 

Retention, Retirement or Separation. Washington, 

DC: US Dept of the Army; February 8, 2006. 

8. Army Regulation 600-60: Physical Performance 

Evaluation System. Washington, DC: US Dept of the 

Army; February 28, 2008. 

9. Policy Guidance for the Disability Evaluation System 

and Establishment of Recurring Directive-Type 

Memoranda. Washington, DC: Under Secretary of 

Defense for Personnel and Readiness, US Dept of 

Defense; May 3, 2007:4. Available at: https://

www.hrc.army.mil/SITE/Active/TAGD/Pda/

DoD_DTM_3_May_2007.pdf. Accessed December 

14, 2009. 

10. Policy Memorandum on Implementing DisabilityRelated Provisions of the National Defense 

Authorization Act of 2008 (Pub L. 110-181). 

Washington, DC: Office of the Under Secretary of 

Defense, US Dept of Defense; October 14, 2008. 

Available at: http://prhome.defense.gov/docs/

NDAA%2008%202%20PM%20sm.pdf. Accessed 

December 8, 2009. 

11. Army Regulation 600-20: Army Command Policy. 

Washington, DC: US Dept of the Army; March 18, 

2008 [revised November 30, 2009]. 

12. US Army Human Resources Command. Policy/

Guidance Memorandum #4: Processing Reserve 

Component (RC) Nonduty Related Cases. 

Washington, DC: US Dept of the Army; September 

26, 2002. Available at: https://www.hrc.army.mil/

site/active/tagd/pda/pgm_04.htm. Accessed 

December 9, 2009. 

13. Dept of Veterans Affairs Schedule for Rating 

Disabilities, 38 CFR Part 4. Available at: http://

www.warms.vba.va.gov/bookc.html. Accessed 

December 15, 2009. 

14. Department of the Army Pamphlet 611-21: Military 

Occupational Classification and Structure. 

Washington, DC: US Dept of the Army; January 22, 

2007. 

15. 10 USC §1216a (2009). 

16. DoD Instruction 6040.44: Lead DoD Component for 

the Physical Disability Board of Review. [change 1]. 

Washington, DC: US Dept of Defense; June 2, 

2009:1-2. Available at: http://www.dtic.mil/whs/

directives/corres/pdf/604044p.pdf. Accessed 

December 14, 2009. 

17. Under Secretary of Defense for Personnel and 

Readiness. Memorandum: Policy and Procedural 

Directive-Type Memorandum (DTM) for the 

Disability Evaluation System (DES) Pilot Program. 

Washington, DC: US Dept of Defense; November 21, 

2007. 

18. Under Secretary of Defense for Personnel and 

Readiness. Memorandum: Policy and Procedural 

Update for the Disability Evaluation System (DES) 

Pilot Program. Washington, DC: US Dept of 

Defense; December 11, 2008. 

AUTHOR

Mr Dorotheo is Assistant Chief, Office of Soldiers 

Counsel and Legal Assistance, Office of the Center 

Judge Advocate, Walter Reed Army Medical Center, 

Washington, DC. 
20 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

The May 22, 2009 rapid action revision of Army 

Regulation 40-68 1

 did much to distinguish the 

differing roles and procedures of peer review in the 

risk management setting from its use in the professional review process at Army medical treatment 

facilities (MTFs). Patient safety is the ultimate goal of 

peer review in both peer review tracks. Risk management peer review sometimes runs concurrently with or 

generates subsequent peer review for professional 

purposes. However, there are significant differences 

between the two. 

Peer review is a tool used in the risk management 

(RM) context to further the RM goals of preventing 

the loss of human, materiel and financial resources, as 

well as limiting the negative consequences of adverse 

or unanticipated healthcare events through timely 

documentation, review, and analysis.1(p106) Peer review 

in the professional review context is designed for the 

disposition of clinical privileging/practice actions. 

Professional peer review can adversely impact 

provider credentials and therefore requires greater due 

process protections such as hearing and appeal rights. 

Risk management peer review is governed by chapter 

13 of Army Regulation 40-68 1(pp108-113) and is triggered 

either by occurrence of a potentially compensable 

event (PCE), filing of a medical claim, or notification 

of payment of a claim settlement or award. In each of 

these cases risk management peer review is a 

confidential quality assurance protected process that 

requires the multidisciplinary cooperation of legal, 

clinical, and quality management administrative staff 

members. The Army Medical Command (MEDCOM) 

Quality Management Division accomplishes its 

oversight and corporate tracking responsibilities for 

risk management peer reviews through the use of the 

Centralized Credentials Quality Assurance System 

database. Chapter 13 of Army Regulation 40-68

specifies frequent and incremental MTF reports/notifications into the Centralized Credentials Quality Assurance System at every step of the process, from discovery of a PCE or notice of a claim until final resolution.

POTENTIALLY COMPENSABLE EVENT INITIATED RISK

MANAGEMENT PEER REVIEWS

A PCE is defined in Army Regulation 40-68 as 

an adverse event that occurs in the delivery of health 

care or services with resulting injury to the patient. It 

includes any adverse event or outcome, with or without 

legal fault, in which the patient experiences any 

unintended or unexpected negative result. It pertains to 

all patients regardless of beneficiary status....1(p167) 

This definition includes cases involving death or 

disability of a military member as a result of medical 

or dental care, all of which are investigated as PCEs 

under Army Regulation 40-68. 

Departmental/Service Level Peer Review 

PCEs are most commonly identified by MTF risk 

managers from incident reports* originating at the 

point of care, or from the verbal or written statements 

of patients, family members, or healthcare staff. An 

initial departmental/service level peer review is 

conducted as soon as possible in order to capture 

information about the PCE while memories are fresh 

and records and personnel are still readily available. 

This peer review is conducted for every healthcare 

provider significantly involved in the PCE. The initial 

peer review is often conducted by an individual peer 

reviewer who is not involved in the case in question. 

Army Regulation 40-68 defines a peer as “an 

individual from the same professional discipline/

Risk Management: The Role of Peer Review 

in Potentially Compensable Event and 

Medical Malpractice Claims Processing in 

the Army Medical Department 

LTC Anthony J. Kutsch, JAG, USAR 

*Department of the Army Form 4106 
 January – March 2010 21

specialty to whom comparative reference is being 

made.”1(p166) Regional medical commands assist in 

obtaining peer reviewers from other MTFs if a facility 

lacks sufficient personnel to conduct an impartial and 

unbiased peer review. Initial departmental/service 

level peer reviews investigate the clinical facts and 

circumstances surrounding the PCE and render 

standard of care and attribution determinations that are 

forwarded to the MTF risk management committee for 

consideration. 

Risk Management Committee Level Peer Review 

The risk management committee peer review likewise 

investigates the clinical facts and circumstances 

surrounding the PCE and renders a standard of care 

(SOC) determination (“SOC-Met,” “SOC-Not Met,” 

or “Indeterminate”) and an attribution determination 

for each significantly involved healthcare provider. 

The specific rationale for these findings is included in 

the report, along with follow-up actions related to 

systems or process issues, any apparent trends with 

recommendations for improvement, and the status of 

any pending claims. The risk management committee 

report/minutes may also include recommendations for 

the MTF credentials committee for privilege/practice 

related actions (potentially initiating the alternative 

track of peer reviews that occur under the professional 

review system established in chapter 10, Army 

Regulation 40-681(p76)). Practitioner-specific findings 

are reported to the MTF credentials committee and/or 

department chief (in the case of a nonprivileged professional), and the risk management committee report/

minutes are then forwarded through quality management channels to the MTF commander. When 

required, regional medical commands provide support 

for MTFs lacking local risk management committee 

oversight. 

Due Process Considerations 

MTF-level risk management peer reviews entail only 

minimal due process procedures: significantly 

involved healthcare providers are notified in person or 

by certified return-receipt requested mail of the 

pending peer review, given access to medical records 

and redacted relevant documents, and given the 

opportunity to submit written statements. Local policy 

may allow in-person presentation of information by 

significantly involved providers, but will not permit 

their presence at risk management committee 

deliberations. The administrative nature and nonadversarial data collection and preservation purposes 

of PCE-initiated peer reviews explain the absence of 

greater formality or heightened due process 

protections. 

If a PCE does not ripen into a medical malpractice 

claim or form the basis of a separate professional 

review for adverse privileging action, then the PCEinitiated risk management peer review concludes at the 

MTF level with the completion of required Centralized 

Credentials Quality Assurance System notifications 

and the report to the MTF commander. Exceptions to 

this are cases of a death or disability to a military 

member as a result of medical or dental care, all of 

which go beyond the MTF for further peer review and 

potential Defense Practitioner Data Bank reporting. 

MEDICAL MALPRACTICE RISK MANAGEMENT PEER

REVIEWS

Medical malpractice peer reviews are triggered by the 

notification of a claim alleging substandard care to the 

MTF from the US Army Claims Service or the Center 

Judge Advocate or Staff Judge Advocate office at 

which the claim was filed. This includes every claim 

of malpractice filed under the Federal Tort Claims 

Act,2

 the Military Claims Act,3 the International 

Claims Settlement Act,4

 or the Foreign Claims Act.5

The goals and procedures of the medical malpractice 

peer review at the MTF level are identical to those of 

the PCE-initiated peer review described above. In fact, 

an MTF peer review will not be repeated when a 

medical malpractice claim arises out of the same care/

provider reviewed previously in a properly conducted 

PCE-initiated peer review. 

Peer review ceases at the MTF level unless a medical 

malpractice peer review instigates a separate 

professional peer review under Chapter 10 of Army 

Regulation 40-68 1(pp71-93) or there is a payment based 

on the underlying claim. Cases in which a medical 

malpractice claim results in a monetary award (“paid 

claim” cases) are elevated beyond the MTF for 

additional stages of peer review. Peer reviews that 

occur beyond the MTF take on an additional objective: 

facilitating the determination of whether The Surgeon 

General of the Army has a statutory requirement to file 

a report to the National Practitioner Data Bank 

(NPDB) under the Healthcare Quality Improvement 

Act of 1986.6

 Notification of a paid claim is of 
22 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

particular importance as it starts the clock running on a 

180-day period during which The Surgeon General 

must make a reporting determination or the NPDB 

report becomes mandatory under Department of 

Defense [regulation] 6025.13-R.

7(p76) Paid claims 

include any monetary award arising out of claim 

settlement by US Army Claims Service, a host nation 

(International Claims Settlement Act Claims), or a 

claim settled or adjudicated by the Department of 

Justice. 

Peer review also continues beyond the MTF for cases 

of death or disability to a military member as the result 

of medical or dental care, regardless of whether there 

has been a paid claim. Medical malpractice claims by 

the service members themselves are barred by the 

Feres doctrine.* However, these cases are referred into 

the risk management peer review system when a 

Medical Evaluation Board (MEB) or Physical 

Evaluation Board (PEB) finds that care rendered to the 

service member deviated from the standard of care. A 

“standard of care not met” determination and 

attribution of responsibility in these cases may result in 

a report to the Defense Practitioner Data Bank rather 

than the NPDB. 

Unlike their civilian counterparts, healthcare providers 

in the military healthcare system are afforded multiple 

peer reviews when they are the subject of a NPDB 

report. MEDCOM Quality Management Division 

coordinates peer review that occurs above the MTF 

level. All cases are reviewed by a discipline/specialty 

clinical expert designated by The Surgeon General 

who will either submit a written report to or participate 

as a member of the MEDCOM Special Review Panel 

(SRP). 

The SRP consists of at least 3 privileged providers, at 

least one of whom is from the same specialty or 

discipline as the provider under review. The provider 

under review is notified of the pending SRP and 

typically given 15 days to submit any additional 

written information on his or her behalf. The SRP 

review is an administrative procedure to which the 

rules of evidence are not applied. The SRP considers 

any new information submitted by the provider along 

with all previous peer reviews, investigative reports, 

relevant clinical records, and a summary of the administrative claim adjudication or litigation disposition 

documents. 

An additional external peer review is sought whenever 

an initial SRP peer review makes a “standard of caremet” (SOC-Met) determination, whenever there is a 

SOC Not-Met determination but it is attributed to a 

“systems error” rather than an individual provider, or 

at the discretion of the SRP. The current designee by 

the Assistant Secretary of Defense (Health Affairs) for 

external peer review is MAXIMUS, Inc (11419 Sunset 

Hills Road, Reston, Virginia 20190). The SRP 

reconvenes for a second and usually final time to 

consider the results of the external peer review by 

MAXIMUS. If necessary due to some unresolved issue 

in the case record, the SRP may elect to seek 

additional information and hold additional reviews. 

The SRP makes a SOC determination and attribution 

by majority vote as well as a recommendation on 

NPDB reporting to The Surgeon General. The Surgeon 

General is the sole reporting authority to the NPDB. 

Regulations allow delegation of reporting authority to 

the SRP for cases in which all levels of peer review 

agree SOC Not-Met, however this delegation is not 

currently exercised. 

Section 14-3 of Army Regulation 40-68 1(pp114-115) sets 

forth procedures, specific criteria, and legal review 

requirements for reports to the NPDB. In order for 

there to be an NPDB report, there must be a finding 

that the provider committed a deviation from the 

standard of care and that the deviation was the cause of 

harm that gave rise to a payment. An NPDB report of a 

trainee requires additional findings that the trainee 

acted outside the scope of his or her practice or that his 

or her deviation from standard of care was not reasonably foreseeable by a supervisor. The most common processing avenues of paid-claim medical malpractice cases to a final determination on NPDB 

reporting are shown in the Figure. 

The Army risk management peer review system is 

designed to carefully balance numerous important 

interests: patient safety, data collection and preservation, protection of healthcare provider credentials 

and reputations, and accountability and disclosure to 

the public in the case of substandard care. The system 

Risk Management: The Role of Peer Review in Potentially Compensable Event and Medical Malpractice 

Claims Processing in the Army Medical Department 

*The Feres doctrine is the term describing the result of a case8

which generally precludes successful suits by service 

members for personal injury or death that is incurred incident 

to service, whether or not they were suffered in the 

performance of their duties. 
 January – March 2010 23

THE ARMY MEDICAL DEPARTMENT JOURNAL

relies heavily on frequent communication with and 

oversight by the MEDCOM Quality Management 

Division through the Centralized Credentials Quality 

Assurance System, as well as the coordination of risk 

managers, Army lawyers and unbiased peer reviewers. 

REFERENCES

1. Army Regulation 40-68: Clinical Quality 

Management. Washington, DC; US Dept of the 

Army; February 26, 2004 [revised May 22, 2009]. 

2. 28 USC §2671(b)(1). 

3. 10 USC §2733. 

4. 22 USC §1621. 

5. 10 USC §2734-2736. 

6. 42 USC §11101. 

7. Department of Defense 6025.13-R: Military Health 

System Clinical Quality Assurance Program 

Regulation. Washington, DC: US Dept of Defense; 

June 11, 2004. 

8. Feres v United States, 340 US 135 (1950). 

AUTHOR

LTC Kutsch is a Drilling Individual Mobilization 

Augmentee currently assigned to the US Army Medical 

Command Office of the Staff Judge Advocate, Fort 

Sam Houston, Texas. 

The most common processing avenues of paid-claim medical malpractice cases to a final determination 

on NPDB reporting. 

Standard of Care and NPDB 

Determination Flow Sheet: 

Risk Management Peer Reviews 

(MED-MAL Claims) 

 The SRP and TSG often have the benefit of 

additional peer reviews obtained by USARCS 

for claims processing 

 In practice, multiple SRP reviews may occur 

when the SRP seeks additional information 

and opts to reconvene 

NPDB Report 

or DPDG 

(Feres-Barred Case) 

Return to SRP 

for attribution 

and provider input CASE CLOSED 

Articles published in the Army Medical Department Journal are indexed in 

MEDLINE, the National Library of Medicine’s (NLM’s) bibliographic database 

of life sciences and biomedical information. Inclusion in the MEDLINE 

database ensures that citations to AMEDD Journal content will be identified to 

researchers during searches for relevant information using any of several 

bibliographic search tools, including the NLM’s PubMed service. 
24 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

BACKGROUND

In 1914, in the case of Schloendorff v Society of New 

York Hospital, Judge Benjamin Cardozo stated: 

Every human being of adult years and sound mind has a 

right to determine what shall be done with his own 

body; and a surgeon who performs an operation without 

his patient's consent commits an assault [today, a 

battery] for which he is liable in damages.1

This judicial determination of the primacy of 

individual autonomy has grown into the common law 

doctrine of informed consent.2

 While Schloendorff

and earlier cases, such as Slater v Baker and 

Stapleton,

3

 asked only if the patient had consented to 

the particular procedure, later cases have looked to 

see if consent was sufficient to be considered 

“informed.” 

Canterbury v Spence4

 is perhaps the leading case on 

informed consent. After a statement of the facts, it 

reads much like a law review article, and explores the 

key questions regarding informed consent. What is 

the origin of the physician's duty to disclose? What is 

the scope of the duty? Is the duty physician-centered, 

or patient-centered? What are the exceptions to the 

duty? What is the role of causality? Canterbury, by 

itself, provides the reader an excellent basis in the 

law of informed consent. 

The logical and judicially recognized principle 

converse to informed consent might well be called 

“informed refusal” and the entire subject regarded as 

“informed decision-making.” While an in-depth 

examination of informed refusal is beyond the scope 

of this article, it must be pointed out that informed 

consent and informed refusal should be regarded as 

two sides of the same coin. To speak of informed 

consent without recognizing a right of informed 

refusal is to render the former meaningless. 

CONSENT GENERALLY

Simply stated, the general rule is that informed 

consent is required before medical care or treatment 

can be given.5

 The definition or extent of that consent 

is a matter of state law.6

 It is generally accepted, 

however, that consent has 3 elements: decisionmaking capacity, information, and voluntariness.7

The elements of decision-making capacity and information can be further divided. Decision-making capacity has 2 subelements: legal age,8

 and sufficient or 

appropriate understanding. Information has 4 subelements: the treatment or procedure that is proposed; 

the hoped-for benefits; the risks; and the reasonable 

alternatives, including the likely effect of no medical 

intervention at all. Even when the subelements of 

information are defined, one is still left with the question of how these are to be determined. There are 

basically 2 ways. The older is to ask, “What would a 

reasonable and prudent physician disclose in such a 

situation?” The newer requires the physician to ask, 

“What would a reasonable patient in such a situation 

want to know, taking into account the physician’s 

specific knowledge about this particular patient?” 

The third element of, or requirement for consent, 

voluntariness, cannot be further divided. Clearly, 

voluntariness is the absence of coercive conduct, but 

the extent to which the individual can be influenced 

and still make a voluntary decision is debated. 

Decision-making capacity or incapacity and 

competence or incompetence are not the same things, 

although the terms are often used interchangeably. 

Capacity/incapacity is a medical determination of 

cognitive capability, including the ability to make 

meaningful medical decisions. Competence/

incompetence is a legal determination. An individual 

may be incompetent by reason of age (not having 

attained the statutory age of majority in a state), or 

mental status. 

Consent to Medical Treatment 

Karin Waugh Zucker, MA, JD, LLM, MFS 

Martin J. Boyle, JD 

COL Thomas C. Jefferson, MC, USA 

MAJ Dennis J. Ratliff, JAG, USAR 
 January – March 2010 25

In most real life situations, no one seeks a legal 

determination of competence or incompetence. Further, there is no standard definition of capacity for 

physicians to rely upon.9

 Boyle tells us, however, that 

consideration of capacity must include “the 

individual abilities of the patient; the requirements of 

the task at hand; and the consequences likely to flow 

from the decision.”9(p67)

The terms “de jure incompetence” and “de facto 

incompetence” are also used. A de jure incompetent 

is one who has been adjudged an incompetent by a 

court; while a de facto incompetent is one recognized 

as incompetent, but not so adjudged by a court. As 

Berg and her colleagues point out: 

Most cases do not warrant...legal proceedings. The 

issues often are not complex, and the cost of legal 

proceedings is great.8(p187)

Generally, a parent or legal guardian must give 

consent for a minor child. An individual appointed as 

the attorney-in-fact under a durable power-ofattorney for medical care or the next-of-kin, perhaps 

acting under a state’s statutory scheme, typically acts 

for an incompetent adult. 

If there is a general rule requiring informed consent to 

medical care, obviously there are exceptions. Briefly 

those are: 

 Care rendered in an emergency when consent 

cannot be obtained. 

 Care rendered in reliance upon therapeutic 

privilege. 

 Care rendered pursuant to discovery, during 

surgery, of an unanticipated, dangerous condition. 

 Care rendered in reliance upon a specific waiver. 

 Care rendered pursuant to law, such as the preschool immunization of children, or lawful 

regulation. 

 Care rendered pursuant to the order of a court of 

competent jurisdiction. 

CONSENT IN MILITARY FACILITIES AND IN THE MILITARY

Paragraph 5.2.1. of DoD Directive 6025.1310 mandates 

that all facilities providing care to DoD beneficiaries 

maintain accreditation by The Joint Commission* 

(TJC). Accordingly, TJC standards apply in military 

treatment facilities. The Joint Commission Ethics 

Rights and Responsibilities Standard R1.01.03.01 

could not be more direct. It simply states: “Informed 

consent is obtained.”11(p328) Standard R1.01.02.01 

states “Patients have the right to refuse care, treatment, 

and services in accordance with law and 

regulations.”11(p326) Individuals, who would otherwise 

be treated as minors were they not in military service, 

are considered to be emancipated and capable of 

consent as if they were adults,12(p5) subject to command 

aspects of medical care for Soldiers as described in 

Army Regulation 600-20.

13

Medical care furnished without proper authority or 

consent may constitute an assault and battery under 

Article 128, Uniform Code of Military Justice,14 and, 

conceivably, a military healthcare provider could be so 

charged. That is, however, not common. Typically, the 

wrong is considered to be a negligent act. If the 

individual who believed himself wronged were a 

military member incident to service at the time of the 

injury, the Feres doctrine†

 prohibits him from 

successfully suing the government, such as recovering 

monetary damages, under the Federal Tort Claims 

Act,16 which protects the healthcare provider (military, 

General Schedule employee, and many contractors) 

who negligently caused the injury from personal 

liability. If the injury occurred overseas, recovery 

under the Military Claims Act17 is similarly barred, as 

is recovery from the healthcare provider. If the 

individual who believed himself wronged by a 

negligent act were a proper plaintiff (a civilian), he 

might seek and recover monetary damages from the 

government under the Federal Tort Claims Act or, if 

the wrong had occurred overseas, by a claim under the 

Military Claims Act. Again, the healthcare provider 

would be immunized from personal liability if his or 

her act were characterized as negligence. 

Soldiers 

Army Regulation 600-20 addresses this subject in a 

straightforward fashion. Subparagraph 5-4a. states: 

Necessary medical care. A Soldier on active duty or 

active duty for training will usually be required to 

*The Joint Commission (One Renaissance Blvd, Oakbrook Terrace, Illinois 60181) is a private sector, US-based, not-for-profit 

organization founded in 1951. The Joint Commission operates accreditation programs for a fee to subscriber hospitals and 

other healthcare organizations. 

†The Feres doctrine is the term describing the result of a case15 which generally precludes successful suits by service members 

for personal injury or death incurred incident to service, whether or not they were suffered in the performance of their duties. 
26 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

submit to medical care considered necessary to preserve 

his or her life, alleviate undue suffering, or protect or 

maintain the health of others....13(p36)

Care that “may” be provided without the service 

member's consent includes emergency care, 

immunizations, isolation and quarantine, detention for 

necessary medical care or to prevent harm to the 

service member or others, diagnostic medical care, and 

physical and other examinations. If an individual 

refuses care that is deemed necessary but is of a type 

that would not be required over his or her objection, 

that individual is typically referred to a medical board. 

Family Members 

Family members who are not themselves military 

members will be afforded the same rights with regard 

to informed consent as if they were in a civilian 

hospital. The law of the state where the facility is 

located applies unless there is federal law on point or 

unless a Status of Forces Agreement provides to the 

contrary.12(p3) Situations where federal law clearly 

applies include restrictions on abortions and physicianassisted suicide.18

Special Situations 

Consent for and by Nonmilitary Minors

Most states have statutes addressing consent by 

minors. Some provide different ages of consent for 

different procedures. Many allow a lower age of 

consent for treatment of sexually transmitted diseases 

than for other purposes. Some states allow physicians 

to decide whether a minor is sufficiently mature to 

consent to a particular procedure. Other states have 

laws which address minority itself, specifying whether 

certain situations such as marriage or childbirth 

emancipate a minor. Army Regulation 40-400 states 

that if law does not prohibit consent by a minor, the 

healthcare provider will determine whether the minor 

is sufficiently mature to consent to a particular 

procedure and, if that determination is in the 

affirmative, no parental consent is necessary.12(pp4-5)

Reliance on Surrogate Decision‐Makers

According to Army Regulation 40-400,

12(pp3-4) absent 

an emergency, consent must be obtained from or on 

behalf of a nonmilitary person. That consent may be 

based upon a judicial determination of incompetency 

and appointment of a guardian, a power-of-attorney for 

medical care, or a statutory scheme setting forth 

individuals who may consent for incompetents. In the 

absence of such a statutory scheme, the consent of the 

spouse or next-of-kin will be required except in 

emergencies. 

Involving Relatives in the Decision‐Making Process

Privacy laws may well prohibit discussing the 

specifics of a patient's condition with family members 

even when that discussion would seem to be in the 

patient's best interest. For that reason, physicians 

should be encouraged to talk with their competent 

patients about including a family member in discussions when the physician believes it to be necessary. If 

the patient consents to that, the physician should make 

an appropriate note in the patient's chart and have the 

patient complete and sign any forms required. 

Sterilization of Incompetents

Healthcare providers are required to seek legal advice 

about the right of a parent or guardian to consent to the 

sterilization of an incompetent, either a minor or a 

mentally retarded adult who is deemed to lack decision

-making capacity. There is no pat answer; this too is a 

matter of state law. Suffice it to say that the pendulum 

has swung far back from the time Oliver Wendell 

Holmes authorized the sterilization of Carrie Buck, 

saying, “Three generations of imbeciles are enough.”19

CONCLUSION

A search of a medical school library and of several 

libraries of allied health schools indicated there was 

little new in the law of informed consent. It is well 

settled that, absent one of the exceptions, there must be 

consent and it must be informed. What constitutes the 

informational element is a matter of state law but is 

generally well set out in Canterbury v Spence.

4

 There 

appears to be some academic interest in considering 

not the informational element of informed consent but 

the question of comprehension. Is it enough that the 

information is given to an individual of normal 

intelligence? Should healthcare providers also be 

looking at what patients understand? What is the 

reading level of the average American; must consent 

forms, to be meaningful, be written at, or below, that 

level? Is bad news absorbed as well as neutral 

information or good news? How much information can 

be assimilated in one visit with a healthcare provider? 

Should patients be encouraged to bring a family 

member to appointments, so that there is someone with 

Consent to Medical Treatment 
 January – March 2010 27

THE ARMY MEDICAL DEPARTMENT JOURNAL

whom to discuss the information received at the visit? 

As the law continues to develop in this area, we will 

wrestle with these questions and others in an attempt 

to define comprehension, rather than information. 

REFERENCES

1. Schloendorff v Society of New York Hospital, 105 NE 

92 (1914). 

2. Beauchamp TL, Childress JF. Principles of Bioethics. 

Cary, NC: Oxford University Press; 2008. 

3. Slater v Baker and Stapleton, 95 Eng Rep (KB 1767). 

4. Canterbury v Spence, 464 F 2d 772 (DC Cir 1972). 

5. Rosoff AJ. Informed Consent. Rockville, MD: Aspen 

Systems Corp; 1981. 

6. Lo B. Resolving Ethical Dilemmas: A Guide for 

Clinicians. 2nd ed. Philadelphia, PA: Lippincott 

Williams & Wilkins; 2000. 

7. Boyle RJ. The Process of Informed Consent. In: 

Fletcher JC, Boyle RJ, eds. Introduction to Clinical 

Ethics. Hagerstown, MD: University Publishing 

Group; 1995. 

8. Berg JW, Appelbaum PS, Lidz CW, Parker LS. 

Informed Consent: Legal Theory and Clinical 

Practice. Cary, NC: Oxford University Press; 2001. 

9. Boyle RJ. Determining Patients’ Capacity. In: 

Fletcher JC, Boyle RJ, eds. Introduction to Clinical 

Ethics. Hagerstown, MD: University Publishing 

Group; 1995. 

10. DoD Directive 6025.13: Medical Quality Assurance 

in the Military Health System. Washington, DC: US 

Dept of Defense; May 4, 2004:3. 

11. Comprehensive Accreditation Manual for Hospitals: 

The Official Handbook. Oakbrook Terrace, IL: Joint 

Commission on Accreditation of Healthcare 

Organizations; January 2009. 

12. Army Regulation 40-400: Patient Administration. 

Washington, DC: US Dept of the Army; February 6, 

2008. 

13. Army Regulation 600-20: Command Policy. 

Washington, DC: US Dept of the Army; March 18, 

2008 [revised 11 February 2009]. 

14. Uniform Code of Military Justice, 64 stat 109, 10 

USC. 

15. Feres v United States, 340 US 135 (1950). 

16. 28 USC §§1346(b) and 2671-2680. 

17. 10 USC §2733. 

18. 43 USC §14401 et seq, the Assisted Suicide 

Restriction Act of 1997. 

19. Buck v Bell, 274 US 200 (1927). 

AUTHORS

Ms Zucker is an Associate Professor, Army-Baylor 

University Graduate Program in Health and Business 

Administration, Fort Sam Houston, Texas. 

Mr Boyle is an attorney with the Department of 

Veterans Affairs, Audie L. Murphy Hospital, San 

Antonio, Texas. 

COL Jefferson is Assistant Chief, Department of 

Clinical Investigation, Brooke Army Medical Center, 

Fort Sam Houston, Texas and a Consultant in Medical 

Ethics to The Surgeon General. 

MAJ Ratliff is a student in the Army-Baylor University 

Graduate Program in Health and Business 

Administration, Fort Sam Houston, Texas. 
28 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

INTRODUCTION

What is medical futility and who decides? Over the 

past few years, several states have enacted medical 

futility statutes which allow health care providers to 

refuse a patient’s request for life-sustaining medical 

treatment where such treatment will not provide 

significant benefit or would be contrary to generally 

accepted health care standards. Notwithstanding these 

legislative initiatives, media accounts illustrate the 

continued difficulty of presuming to answer ethical 

dilemmas through legal methodologies and judicial 

intervention. 

DEFINITIONS

“Life-sustaining treatment” means treatment that, 

based on reasonable medical judgment, sustains the 

life of a patient and without which the patient will die. 

The term includes both life-sustaining medications and 

artificial life support, such as mechanical breathing 

machines, kidney dialysis treatment, and artificial 

nutrition and hydration. The term does not include the 

administration of pain management medication or the 

performance of a medical procedure considered to be 

necessary to provide comfort care, or any other 

medical care provided to alleviate a patient’s pain.1

The term “medical futility” generally refers to 

interventions that are unlikely to produce any 

significant benefit for the patient.2

 Two kinds of 

medical futility are often distinguished: quantitative 

futility, where the likelihood that an intervention will 

benefit the patient is exceedingly poor; and qualitative 

futility, where the quality of benefit an intervention 

will produce is exceedingly poor. 

HISTORICAL BACKGROUND OF MEDICAL FUTILITY

The concept of medically futile treatment can be traced 

back to the time of Hippocrates. Ancient Greek healers 

suggested that the 3 goals of medicine were cure, relief 

of suffering, and the refusal to treat those 

“overmastered by their illness.”3

 Patients were 

admonished not to ask healers to attempt that which 

was impossible to medicate. The text also relates that 

to attempt futile treatment was to display an ignorance 

“allied to madness.” The concept of medical futility 

has been counterbalanced by the rapid advance of 

medical science, especially in the last several decades 

beginning in the 1960s, when life-sustaining medical 

treatments such as the mechanical ventilator became 

available. 

The case of Karen Ann Quinlan was the first in a 

series of decisions establishing the so-called right to 

die.4

 At the age of 21, Quinlan lapsed into a coma after 

coming home from a party. Although Quinlan was 

removed from active life support over the objection of 

her doctors in 1976, she continued to live in a coma for 

almost a decade until her death from pneumonia in 

1985. 

The Quinlan case was followed in 1987 by the case of 

Nancy Cruzan.5

 In January of 1983, Cruzan lost 

control of her car, was thrown from the vehicle and 

landed face down in a water-filled ditch. Paramedics 

found her with no vital signs, but they resuscitated her. 

After several weeks of remaining nonresponsive in a 

coma, she was diagnosed as being in a persistent 

vegetative state (PVS). Surgeons inserted a feeding 

tube for her long-term care. Her husband and parents 

waited for a more substantial recovery, but eventually, 

after 4 years, accepted that there was no hope. Her 

parents eventually asked to have Cruzan's feeding tube 

removed, but the hospital demanded a court order to 

that effect. The case made its way to the US Supreme 

Court which, in 1992, concluded that the US 

Constitution grants a competent person the right to 

refuse lifesaving hydration and nutrition. The Court 

noted that "most state courts have based a right to 

refuse treatment on the common law right to informed 

consent...or on both that right and a constitutional 

privacy right." The Court also held that states may 

require "clear and convincing evidence" with regard to 

a person's wishes, and that a state may properly decline 

to make judgments about the quality of a particular 

Medical Futility 

Mark P. Sposato, JD 
 January – March 2010 29

individual's life and simply assert an unqualified 

interest in the preservation of human life to be 

weighed against the constitutionally protected interests 

of the individual. 

After the right-to-die cases established patient 

autonomy, physicians began to assert that life 

sustaining medical treatment should be withdrawn or 

withheld because such treatment no longer met the 

legitimate goals of medicine and was thus “futile.” In 

the Wanglie case6

 doctors recommended terminating 

mechanical ventilation for an 86-year old woman in a 

PVS on futility grounds.7

 In the Baby K case,8

physicians and a hospital ethics committee argued in 

1993 that mechanical ventilation of an anencephalic 

child was “futile” and served “no therapeutic or 

palliative purpose” and was otherwise medically 

unnecessary and inappropriate. In both cases, courts 

came down in favor of families being the final arbiter 

as to the appropriateness of continuing or stopping 

treatment that might be considered medically futile. 

However, the patient’s absolute right to determine his 

or her course of treatment began to erode when, in 

1995, a Massachusetts court found in favor of a 

physician’s decision to withhold life-sustaining 

treatment.9

 Catherine Gilgunn was 71 years of age in 

1989, when she suffered the hip injury that would 

ultimately lead to her death. At the time of her injury, 

she already suffered from the effects of 3 prior broken 

hip repairs, diabetes, heart disease, chronic urinary 

infections, Parkinson's disease, and a stroke, and had 

recently undergone treatment for breast cancer. Her 

daughter allowed her to delay seeking medical 

attention for the new hip injury for several weeks, and 

before surgery could occur, Mrs Gilgunn suffered a 

number of seizures, resulting in brain damage and 

coma. With the approval of father and siblings, the 

daughter was designated Mrs Gilgunn's surrogate. 

After consulting the hospital's Optimum Care 

Committee (OCC), and despite the fact that the 

surrogate had requested that "everything be done," Mrs 

Gilgunn's physician placed a DNR order in her chart. 

Members of the OCC felt that the family's opinion was 

not relevant since CPR was not a genuine therapeutic 

option, and Mrs Gilgunn should not suffer what they 

considered to be mistreatment simply because the 

family was not prepared for her death. After the 

hospital's legal division approved the DNR order, the 

doctor started weaning her from the ventilator without 

the surrogate’s permission, and with the DNR on her 

chart. Mrs Gilgunn died 3 days later. At the time of her 

death, the surrogate was attempting to arrange for her 

mother to be transferred to a long-term facility. The 

surrogate brought the case to court, charging that the 

hospital had caused the family mental pain and 

suffering. A jury ultimately rejected the family’s 

claims, finding in favor of the hospital and physicians. 

In 1993, the National Conference of Commissioners 

on Uniform State Laws completed drafting the 

Uniform Health Care Decisions Act (UHCDA).10 The 

overall objective of the UHCDA is to encourage the 

creation and enforcement of advance health care 

directives and to provide a means for making health 

care decisions for those who may have failed to 

adequately plan for them. New Mexico and Maine 

adopted the UHCDA in 1995, and the following states 

have since adopted a combined advance directive 

statute modeled after the UHCDA: Alabama, Alaska, 

Arizona, California, Connecticut, Delaware, Florida, 

Georgia, Hawaii, Idaho, Kentucky, Maryland, 

Minnesota, Mississippi, New Hampshire, New Jersey, 

Oklahoma, Oregon, Tennessee, Utah, Vermont, 

Virginia, West Virginia, and Wyoming. The UHCDA 

generally requires that health care providers comply 

with patient and surrogate health care decisions. 

However, the UHCDA also provides that a healthcare 

provider may decline to comply with an individual 

instruction or healthcare decision that requires 

“medically ineffective” health care or health care 

contrary to generally accepted health care standards. 

The Act also allows a health care provider to decline to 

comply for “reasons of conscience.” Finally, while the 

model UHCDA generally confers immunity to health 

care providers and institutions for acting in good faith 

and in accordance with generally accepted health care 

standards, it does not confer immunity to health care 

providers or institutions for the unilateral exercise of 

medical discretion. 

In 1994, the American Medical Association’s (AMA) 

Counsel on Ethical and Judicial Affairs opined: 

Physicians are not ethically obligated to deliver care 

that, in their best professional judgment, will not have a 

reasonable chance of benefiting their patients. Patients 

should not be given treatments simply because they 

demand them. Denial of treatment should be justified 

by reliance on openly stated ethical principles and 

acceptable standards of care, as defined in Opinion 

2.03, “Allocation of Limited Medical Resources,” and 

Opinion 2.095, “The Provision of Adequate Health 

Care,” not on the concept of “futility,” which cannot be 

meaningfully defined.11
30 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

In 1998, the AMA followed its 1994 medical futility 

definition with an opinion which set out proposed 

guidelines for physicians to follow: 

When further intervention to prolong the life of a 

patient becomes futile, physicians have an obligation to 

shift the intent of care toward comfort and closure. 

However, there are necessary value judgments involved 

in coming to the assessment of futility. These 

judgments must give consideration to patient or proxy 

assessments of worthwhile outcome. They should also 

take into account the physician or other provider's 

perception of intent in treatment, which should not be to 

prolong the dying process without benefit to the patient 

or to others with legitimate interests. They may also 

take into account community and institutional 

standards, which in turn may have used physiological or 

functional outcome measures.12

CASE STUDY

Emilio Gonzales was an 18-month-old child afflicted 

with Leigh’s Disease when he died in the Pediatric 

Intensive Care Unit (ICU) at Children’s Hospital in 

Austin, Texas, in May 2007. At the time of his death, 

Emilio could not see, speak, or eat. A ventilator 

breathed for him, and he was kept mostly asleep by a 

combination of drugs administered for palliative 

purposes. According to one media account, when 

Emilio’s 23-year-old mother held him in her arms, he 

would sometimes make facial expressions that the 

mother would say were a smile. At the same time, an 

ICU nurse standing next to the mother thought that 

Emilio was grimacing in pain.13

Emilio’s medical condition became newsworthy when 

a dispute arose between the hospital and Emilio’s 

mother in regard to the child’s course of treatment. 

Without mechanical respiration, treating physicians 

believed that Emilio would die within minutes or 

hours. The hospital contended that keeping the child 

alive on a ventilator was painful for him and useless 

against his illness, a rare progressive and fatal 

neurometabolic disorder. Mrs Gonzales disagreed and 

wanted to keep her son on the ventilator, allowing him 

to die “naturally, the way God intended.” As the result 

of complications during her pregnancy, Mrs Gonzales 

could not have more children. She believed that her 

Catholic faith compelled her to keep her son alive, 

regardless of doctors’ beliefs that Emilio could not 

recover and continued treatment was prolonging his 

suffering. The cost of Emilio’s continuing care was 

paid by Medicare and Medicaid. 

The Texas Children’s Hospital next convened its 

ethics committee, which concluded that Emilio’s case 

was medically hopeless. The hospital then gave notice 

to Mrs Gonzalez that treatment would be withheld 

after 10 days, during which period she could attempt to 

find another facility which would be willing to take 

over Emilio’s care. The hospital administrators 

contacted 31 facilities in an attempt to transfer Emilio 

without success. After the hospital extended the 

deadline once, Mrs Gonzales, with the assistance of 

several right-to-life organizations, obtained a 

temporary restraining order from a county probate 

judge. The judge appointed a guardian ad litem to 

represent Emilio’s interests and scheduled a hearing to 

consider a request by Mrs Gonzales to continue the 

restraining order. Emilio eventually died before the 

hearing commenced, shortly before he reached 19 

months of age. He spent his last 5 months on life 

support. 

THE TEXAS ADVANCE DIRECTIVES ACT OF 1999

The Texas Advance Directives Act (TADA)1 seeks to 

incorporate a due-process standard similar to that 

proposed by the American Medical Association when 

a provider refuses to honor a surrogate’s request for 

continued life-sustaining medical treatment. The 

multistage review process begins with review by the 

hospital ethics or medical review committee. Lifesustaining treatment must be continued during the 

review process. The person responsible for making 

treatment decisions for the patient must be provided 

with 48 hours advance notice of the review process, 

and given an opportunity to attend the committee 

meeting. Once a decision is reached regarding the 

patient’s care, the committee is required to provide 

written notification of the decision to the person 

responsible for making decisions for the patient. If the 

committee agrees with the physician’s decision to 

withdraw life-sustaining treatment from the patient, 

the physician is required to make a reasonable effort to 

transfer to a physician or facility willing to continue 

the patient’s care. The patient must be provided 

available life-sustaining treatment pending transfer. 

However, the physician and hospital are not obligated 

to provide life-sustaining treatment the tenth day after 

the written decision of the ethics committee is 

provided to the person responsible for making the 

patient’s health care decisions, unless ordered to do so 

by an appropriate county or district court. 

Medical Futility 
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THE ARMY MEDICAL DEPARTMENT JOURNAL

The so-called “safe harbor” provision of the TADA 

provides that if the treating physicians, other health 

care providers, and the hospital follow the procedure 

outlined in the TADA, they are immune from civil 

liability for withdrawing life-sustaining treatment from 

a patient. These parties are also not subject to any 

criminal liability or disciplinary action by licensing 

boards, unless they failed to exercise “reasonable 

care.” The limitation on liability provision defines the 

standard of care (TADA §166.160(c)) which shall be 

exercised as 

...that degree of care that a physician, health care 

facility, or health care professional, as applicable, of 

ordinary prudence and skill would have exercised under 

the same or similar circumstances in the same or a 

similar community. 

OTHER STATE MEDICAL FUTILITY STATUTES

Several states have enacted limited medical futility 

provisions within their healthcare statutes. 

In Virginia, when a physician determines that medical 

treatment is “medically or ethically inappropriate,” the 

physician is required to inform the patient or the 

patient’s designated decision-maker of such 

determination and the reasons for it, and if a conflict 

results, the physician must make “a reasonable effort” 

to transfer the patient to another physician, and 

provide the patient or decision-maker at least 14 days 

to effect such transfer.14 Life sustaining care must be 

continued during the pendency of the transfer waiting 

period. The Virginia statute also contains a safe harbor 

provision. The Maryland statute provides that a 

healthcare provider who “intends not to comply with 

an instruction of a health care agent or a surrogate” is 

required to inform the person giving the instruction 

that the provider declines to carry out the instruction; 

that another health care provider may be requested; the 

health care provider will make “every reasonable 

effort” to transfer the patient to another health care 

provider; will assist in the transfer; and, pending 

transfer, will comply with the instructions of the 

patient or designated surrogate.15 The Maryland statute 

contains a general safe harbor provision for health care 

providers who withdraw or withhold health care as 

authorized under the statute. 

California’s probate code authorizes a healthcare 

provider to decline to comply with an individual health 

care decision or instruction that requires “medically 

ineffective” health care or “health care contrary to 

generally accepted health care standards applicable to 

the health care provider or institution.”16 The statute 

also requires the healthcare provider to inform the 

patient or surrogate, make all reasonable efforts to 

assist in transferring the patient to another physician or 

facility, and to continue care until transfer can be 

effected. The California statute does not contain a safe 

harbor provision. 

SOCIETAL CONCERNS ASSOCIATED WITH THE CONCEPT

OF MEDICAL FUTILITY

The use of increasingly scarce healthcare resources to 

provide life-sustaining medical treatment which 

prolongs life but may worsen the quality of that life 

may not be in the best interests of society. Some 

medical ethicists now believe that healthcare providers 

not only have a duty to inform patients, their families, 

or their surrogates about the known or anticipated 

outcomes of medical care, but they also have a duty to 

inform when an intervention may be medically futile 

and palliative care should be initiated so as to conserve 

resources for the entire community. 

The 1990 Patient Self Determination Act17 requires 

healthcare providers to ask patients whether they have 

an advance directive, to include a do-not-resuscitate 

order. A new trend has also been observed whereby 

healthcare providers encourage patients in appropriate 

cases to make an Acceptance of Natural Death request 

when interventions are deemed to be medically 

futile.18

Some common criticisms leveled against the ethical 

concept of medical futility include: medical futility is 

an attempt to increase the power of the physician over 

the patient, contrary to the concept of patient 

autonomy; no professional or societal consensus has 

been achieved in regard to the definition of medical 

futility; medical futility is a useless concept because 

empirical treatment data cannot be applied with 

certainty to any given patient; medical futility 

threatens the free exercise of religion (eg, hoping for a 

miracle); and rationing and medical resource allocation 

will ultimately determine medical futility. These 

criticisms should be considered and addressed by 

hospital ethics committees evaluating the effectiveness 

of life-sustaining medical treatments. 
32 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

CONCLUSION

In the absence of either professional or societal 

consensus about the definition of medical futility, unilateral decision statutes provide a legal basis to withhold life-sustaining medical treatment where such 

treatment would not provide significant benefit or 

would be contrary to generally accepted health care 

standards. In the absence of a state medical futility 

statute, the Texas Advance Directives Act1

 provides a 

workable consensus-based template for legal advisors 

to apply in cases where life-sustaining treatment may 

be medically ineffective. Legal advisors should also 

keep in mind that absent a statutory safe harbor provision, state medical futility acts modeled after the 

Uniform Health Care Decisions Act10 may not protect 

against possible civil, criminal or professional 

sanctions. 

REFERENCES

1. Texas Advance Directives Act, Texas Health & 

Safety Code §§166.002 (1999). 

2. Futility. University of Washington School of 

Medicine Ethics in Medicine Web site. Available at: 

http://depts.washington.edu/bioethx/topics/futil.html. 

Accessed October 7, 2009. 

3. Hippocratic Corpus, the Art. In: Reiser SJ, Dyck AJ, 

eds. Ethics in Medicine: Historical Perspectives and 

Contemporary Concerns. Cambridge, MA: MIT 

Press;1977:6-7. 

4. Matter of Quinlan, 348 A 2d 801 (NJ Super Ct Ch 

Div 1975). 

5. Cruzan v Director, Missouri Department of Health, 

497 US 261 (1990). 

6. In re Conservatorship of Wanglie, No. PX-91-283 

(Minn Dist Ct Hennepin Co July 1991). 

7. Cranford RE. Helga Wanglie’s Ventilator. University 

of Missouri Web site. Available at: http://

web.missouri.edu/~bondesonw/wanglie.html. 

Accessed October 7, 2009. 

8. In the Matter of Baby K, 832 F Supp 1022 (ED Va 

1993). 

9. Gilgunn v Massachusetts General Hospital, No. 92-

4820 (Mass Super Ct Civ Action Suffolk So April 22, 

1995). 

10. Uniform Health Care Decisions Act, §§1-19, 9 ULA 

93 (1993). 

11. American Medical Association Council on Ethical 

and Judicial Affairs Code of Medical Ethics. Opinion 

E-2.035 Futile Care (issued June 1994). 

12. American Medical Association Council on Ethical 

and Judicial Affairs Code of Medical Ethics Opinion 

E-2.037 Medical Futility in End-of-Life Care (issued 

June 1998). 

13. Cohen E. Fight over baby’s life support divides 

ethicists. CNN.com Web site. April 25, 2007. Available at: http://www.cnn.com/2007/HEALTH/04/25/

baby.emilio/index.html. Accessed October 7, 2009. 

14. Health Care Decisions Act, Va Code Ann §54.1-2990 

(1992). 

15. Health Care Decisions Act, Md Ann Code Title 5 §5-

609 (2007). 

16. California Probate Code §4735 (2007). 

17. Patient Self Determination Act of 1990, 42 USC 

§1395 (1990). 

18. Resnick B. Ethics and Medical Futility: The 

Healthcare Professional’s Role. Course lecture 

presented at the Annual Meeting of the National 

Conference of Gerontological Nurse Practitioners; 

September 27-October 1, 2006; Ponte Verda Beach, 

FL. Available at: http://www.medscape.com/viewarti 

cle/550278. Accessed October 7, 2009. 

AUTHOR

Mr Sposato is an Attorney-Advisor with the William 

Beaumont Army Medical Center, Fort Bliss, Texas. 

Medical Futility 

Crest of the William F. Beaumont Army Medical Center, 

Fort Bliss, Texas 
 January – March 2010 33

The history of medical progress is to a large extent 

the history of medical experimentation.1

INTRODUCTION

Clinical Investigation 

Human subjects are an integral part of medical 

research investigation. Testing of a potential drug, 

device, or vaccine in humans is generally required in 

order to receive Food and Drug Administration (FDA) 

licensure. FDA approval and licensure are necessary to 

make the benefits of the new drug, device, or vaccine 

available to the general public. Human testing is 

necessary, in part, because the results of animal testing 

may not be indicative of how a particular drug, device, 

or vaccine will perform in a human. Testing in human 

subjects is conducted as part of a clinical investigation. 

A clinical investigation is an experiment that involves 

a test article (drug, device, or vaccine) and one or more 

human volunteers. A clinical investigation is subject to 

requirements for submission to the FDA, or the results 

of which are intended to be submitted as part of an 

application for a research or marketing permit.2

Substantial Evidence Requirement 

Generally, approval of a potential vaccine by the FDA 

will only occur if clinical investigation reveals that the 

test article is both safe and efficacious, meaning that a 

particular test article will work for its intended 

purpose. A researcher must produce substantial 

evidence from the clinical investigation that shows that 

the vaccine (for example) works in humans. The 

Federal Food, Drug, and Cosmetic Act (FFDCA) 

defines substantial evidence as 

...evidence consisting of adequate and well-controlled 

investigations, including clinical investigations, by 

experts qualified by scientific training and experience to 

evaluate the effectiveness of the drug involved, on the 

basis of which it could fairly and responsibly be 

concluded by such experts that the drug will have the 

effect it purports to have.3

Common Rule 

Biomedical research involving human subjects that is 

conducted or funded by a federal agency is also 

regulated by Department of Health and Human 

Services (HHS) regulations, at 45 CFR 46 (Subpart A) 

as implemented by the given federal agency. This 

regulation is known as the “Common Rule,” having 

been adopted by the Department of Defense (DoD) (at 

32 CFR §219) and 15 other federal agencies in 1991. 

While the FDA regulations and the Common Rule are 

largely harmonized, investigators must be aware of 

some differences.4

 In addition, if a biomedical research 

project involving human subjects does not involve an 

FDA-regulated test article and is not conducted to support FDA licensure, the project will not be regulated 

by the FFDCA and its implementing regulations. 

HISTORICAL EVENTS AND ETHICAL PRINCIPLES

The Nuremberg Code: Voluntary Consent 

With the exception of highly-regulated emergency research conducted without informed consent, and some 

minimal risk research, federal regulations prohibit the 

use of human subjects for research unless the subject’s 

informed consent or the consent of the subject’s legally authorized representative has been obtained.5

 These 

regulations, and others, embody the ethical principles 

set forth in the Nuremberg Code, the Declaration of 

Helsinki, and the Belmont Report. The Nuremberg 

Code is a set of 10 ethical principles that evolved from 

the trials of the Nazi doctors in 1947.6 The key element 

of the Code focuses on voluntary consent. The Code 

was derived from international law, international customs, basic humanitarian considerations, and sensitivities of public conscience.7

 It now represents international common law and is applied in US courts.8

The Declaration of Helsinki: Informed Consent and 

Research Study Review 

The Declaration of Helsinki was formulated by the 

World Medical Association in 1964 as a more specific, 

workable ethical code for medical personnel. The most 

recent revision of this document occurred in 2008.9

Prior to that, it had been revised in 2000, and provisions were clarified in 2002 and 2004. It represents a 

further evolution of the ethical guidelines to be applied 

Biomedical Research Involving 

Human Subjects 

Stephen Maleson, JD 
34 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

by physicians in clinical and nonclinical biomedical 

research. Like the Nuremberg Code, The Declaration 

of Helsinki stresses informed consent while adding a 

requirement for review of the research study.10

The Belmont Report: Ethical Guidelines for 

Protection of Human Subjects 

The Belmont Report11 resulted from study and 

deliberations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-1978). The Commission was 

established by the National Research Act, Pub L 93-

348 (1974), to identify the basic ethical principles concerning human subjects that should be applied in the 

performance of biomedical and behavioral research. 

The Belmont Report sets forth the guidelines that are 

incorporated into federal regulations for the protection 

of human subjects. This guidance is applied in the 

evaluation of research proposals for federal funding. 

Other Developments 

Other noteworthy actions include the creation of the 

President’s Commission for the Study of Ethical 

Problems in Medicine and Biomedical and Behavioral 

Research (1980-1983), the Advisory Committee on 

Human Radiation Experiments (1994), and the 

National Bioethics Advisory Commission (1996). The 

President’s Commission for the Study of Ethical 

Problems in Medicine and Biomedical and Behavioral 

Research was created by Pub L 95-622,12 which 

required all federal agencies to adopt the Common 

Rule. The deliberations of the Advisory Committee on 

Human Radiation Experiments resulted in Executive 

Order 12975,13 which established the National 

Bioethics Advisory Commission (NBAC) in response 

to disclosure of human subject abuses in federally 

supported radiation experiments. The NBAC’s primary 

goal was to develop clear ethical standards for the 

protection of human subjects during the conduct of 

research. The NBAC’s charter expired in 2001, and, in 

that same year, President George W. Bush created the 

President’s Council on Bioethics, which is charged 

with advising “...the President on bioethical issues 

that may emerge as a consequence of advances in 

biomedical science and technology.”14 

ETHICAL PRINCIPLES OF RESEARCH

The consensus within the research and ethics 

communities is that all research should be conducted 

in keeping with 3 basic ethical principles: respect for 

persons, beneficence, and justice. These principles are 

considered to have equal moral force, although their 

implementation may be expressed differently in 

different circumstances. 

Respect for Persons 

Respect for persons includes respect for the autonomy 

of the individual. Autonomy is essentially the right of 

self-determination. Thus, researchers should respect an 

individual’s exercise of self-determination in making 

decisions about his or her body. The Belmont Report11

emphasized that researchers must respect the 

individual by giving weight to his or her informed 

consent to participate in the study and the weighing of 

the relative risks and benefits of procedures that will 

be performed. Respect for persons also acknowledges 

that vulnerable individuals with diminished autonomy 

should be protected from harm or abuse. All of the 

ethical guidelines discussed above focus on autonomy 

of the subject as a key principle. 

Beneficence 

The concept of beneficence requires that researchers 

maximize the potential benefits and minimize potential 

harms to the subject. In other words, potential risk to 

the subject must be reasonable in proportion to the anticipated benefits of the research study and the knowledge sought. In addition, the study must be scientifically meritorious, and the researcher must be qualified to conduct the research and competent to protect 

the subjects from deliberate harm. An individual may 

choose to participate in a study when death is a probable result. However, the responsibility for the individual must always rest with the medical personnel even 

though the subject has given consent. Concern for the 

well being of the individual subject must always 

outweigh the potential benefit to society as a whole.9

Justice 

Justice requires the equitable distribution of the 

benefits and burdens of research among the 

participants and recipients of the benefits of research. 

Recruitment of subjects should not be limited to 

specific categories of persons while the general 

population reaps the benefits of that group’s 

participation. For example, exclusive use of mentally 

disabled persons as human subjects because of a 

perception that they are not socially valuable 

individuals would be improper. Conducting a study 

with this group of subjects may be permissible if the 

study seeks to answer some scientifically valid 

Biomedical Research Involving Human Subjects 
 January – March 2010 35

THE ARMY MEDICAL DEPARTMENT JOURNAL

question about mental disability. Treating a specific 

group differently should be based upon some morally 

relevant justification or meritorious scientific inquiry.

Informed Consent 

Risk/Benefit Analysis. Whether to participate in a 

particular research study is a choice the potential 

subject must make based on adequate and essential 

information presented during the process of “informed 

consent.” Informed consent requires that sufficient 

information about the conduct of the research and 

possible benefits or risks to the subject be presented in 

such a way that the subject can make a reasoned and 

informed decision about whether to participate in the 

research. The standard applied in determining whether 

there has been informed consent is whether there has 

been disclosure of all information that a reasonable 

person would consider material in weighing the 

potential benefits and risks of participation.

Without Coercion. In keeping with the ethical principles 

discussed above, it is important to stress the voluntary 

nature of the subject’s participation throughout the 

informed consent process. The researcher must avoid 

any action or statement that could be construed as 

deceptive, applying undue pressure or influence, or 

seeking to intimidate the potential subject into signing 

the consent document. The potential subject must be 

assured of the ability to withdraw from the study at 

will and without penalty. If payment or other 

compensation is to be made for participation, such 

compensation cannot be so enticing as to be coercive 

or irresistible to the individual. 

Documentation. In the general research community, 

informed consent is usually documented in writing 

with a signed consent form, but may be obtained orally 

in certain circumstances.15 The consent document must 

address all of the 8 basic elements of informed consent 

discussed below and may not include any exculpatory 

language through which subjects are made to waive, or 

appear to waive, any legal rights they may have. 

Furthermore, the consent form should be written in 

nonmedical language that is easily understood by the 

subject. A translation of the consent form for subjects 

who do not understand English must also be provided. 

Continuing Obligation. It is important to remember that 

informed consent is a continuous process. The 

informed consent document is not simply a piece of 

paper to be executed at the beginning of a study and 

then filed and forgotten. The researcher has a 

continuing obligation to notify the subject of any new 

information or changed circumstances that may affect 

his or her participation in the study. The researcher’s 

obligation continues even after the study has 

concluded.16

Selected Elements of Informed Consent 

There are 8 basic elements of informed consent set 

forth in the Common Rule.17 At a minimum, the 8 

elements must become part of the informed consent 

document, but agencies may impose requirements for 

additional disclosures to the subject. Researchers must 

provide a statement to the subject that the study involves research, the purpose of the research, the expected duration of the subject’s participation, an explanation of the procedures to be performed, and identification of any procedures that are experimental. In 

addition, there must be a description of the reasonably 

foreseeable risks to the subject due to his or her participation, as well as benefits anticipated, if any. The 

subject must also be provided with information about 

alternative procedures or treatments that might be beneficial to him or her. Confidentiality of medical or research records must be addressed, as well as an explanation of compensation to be provided, if any. The 

subject must also be informed whether medical care 

and/or compensation will be provided in the case of 

injury related to the study. Of extreme importance is 

the requirement that the subject be made aware that his 

or her participation is voluntary and that he or she may 

withdraw from the study at any time without suffering 

penalties or loss of benefits to which the subject is 

otherwise entitled. Finally, a point of contact must be 

provided concerning the subject’s participation in the 

study. 

FEDERAL LAW AND DOD REGULATIONS

The body of law governing the use and protection of 

human subjects in federally funded or conducted 

research is an amalgam of ethical considerations, 

international common law, US statutes, and specific 

regulations promulgated by federal agencies. In 1991, 

the DoD and 15 other federal agencies adopted HHS 

regulations at 45 CFR 46 (Subpart A) concerning the 

protection of human subjects in federal research. As 

discussed earlier, the adopted regulations are referred 

to as the Common Rule.18 The Common Rule applies 
36 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

to all research funded by the federal government, 

whether intramural or extramural, via grants, contracts, 

cooperative agreements, or cooperative research and 

development agreements. The Common Rule 

incorporates the principles discussed in the Belmont 

Report11 and requires institutional assurances of 

compliance with federal law, the creation of 

institutional review boards, and informed consent of 

the subject or the subject’s legally authorized 

representative to participation in the research study. 

The HHS also published regulations at 45 CFR 46 

Subparts B, C, and D. These Subparts address research 

activities involving fetuses, pregnant women, and 

neonates (Subpart B), prisoners (Subpart C), and 

children (Subpart D). Though these Subparts are not 

part of the Common Rule, these Subparts are made 

applicable to DoD research by paragraph 4.4.1. of 

Department of Defense Directive 3216.02.

19(p3)

10 USC §98020 is a federal statute that applies only to 

research funded by the DoD. 10 USC §980 restricts the 

DoD’s ability to conduct or fund certain research that 

would otherwise be in compliance with the Common 

Rule. It requires the following for DoD-funded 

research involving human subjects: (1) the informed 

consent of the subject must be obtained in advance; 

and (2) if a subject is unable to legally give informed 

consent (eg, children, the mentally ill, unconscious 

persons, trauma victims), the legal representative of 

the subject may give the informed consent of the subject in advance, but only if the research is “intended to 

be beneficial” to the subject. The intent-to-benefit 

requirement of 10 USC §980 creates a challenge in the 

conduct of certain placebo research involving children 

that is otherwise approvable under the Common Rule 

and the HHS Subpart regulating research with 

children. The impact of 10 USC §980 on research 

involving children is discussed later in this article. 

10 USC §980 has also historically made it difficult to 

conduct DoD-funded research involving trauma 

victims and unconscious subjects because it is often 

impossible to get informed consent from such subjects 

or their legal representatives in advance. The National 

Defense Authorization Act of 2002 amended 10 USC 

§980 to address this issue. The amendment permits the 

Secretary of Defense to waive the requirement for 

advance informed consent: 

with respect to a specific research project to advance 

the development of a medical product necessary to the 

armed forces if the research project may directly benefit 

the subject and is carried out in accordance with all 

other applicable laws.21 

Paragraph 4.2.2. of Department of Defense Directive 

3216.02 19(p3) (the implementation directive for 10 USC 

§980), the Secretary of Defense delegated this waiver 

authority to the heads of DoD components (eg, 

Secretary of the Army). Other applicable laws include 

the FDA regulations governing use of investigational 

drugs or devices in emergency research without 

informed consent,22 or, for research not regulated by 

the FDA, the equivalent HHS regulation.23 The waiver 

may be requested for DoD research intended to 

improve treatment of battlefield injuries, using new 

techniques, drugs, or devices, on a research population 

that may be difficult to identify and/or obtain informed 

consent from in advance. 

Department of Defense Directive 3216.02 also creates 

certain DoD-unique obligations for research involving 

human subjects conducted or supported by the DoD 

(eg, through contract, grant, cooperative agreement, or 

other arrangement). For example, paragraph 4.4.3 

states: 

For research involving more than minimal risk to 

subjects (as defined in 32 CFR 219.102(i)), an independent medical monitor shall be appointed by name. 

Medical monitors shall be physicians, dentists, 

psychologists, nurses, or other healthcare providers 

capable of overseeing the progress of research 

protocols, especially issues of individual subject/patient 

management and safety. Medical monitors shall be 

independent of the investigative team and shall possess 

sufficient educational and professional experience to 

serve as the subject/patient advocate.19(p4)

Additionally, paragraph 4.4.3.2. gives medical 

monitors 

...the authority to stop a research study in progress, 

remove individual subjects from a study, and take 

whatever steps are necessary to protect the safety and 

well-being of research subjects until the IRB 

[institutional review board] can assess the medical 

monitor's report.19(p4)

Multiple Army regulations may also affect research 

involving human subjects. Army Regulation 70-25 16

applies to Army RDT&E* research involving human 

subjects. Army Regulation 40-38 24 applies to the 

research involving human subjects in the Clinical 

Biomedical Research Involving Human Subjects 

*Research, development, test and evaluation 
 January – March 2010 37

THE ARMY MEDICAL DEPARTMENT JOURNAL

Investigation Program. Both of those Army regulations 

further govern the Army’s research involving human 

subjects. If Army research involves FDA-regulated 

products, the conduct of such research is also governed 

by Army Regulation 40-7.

25

Institutional review boards (IRBs) are charged with 

protecting the rights and welfare of human subjects 

and to ensure that accepted ethical principles are 

applied in the conduct of research upon humans. The 

IRBs do this primarily by reviewing research plans 

(protocols) and serving as biomedical research ethics 

advisory boards. All Army research studies must be 

reviewed by an IRB whether the research conducted is 

intramural or extramural. All protocols must be 

reviewed prior to beginning the research. Extramural 

research protocols will usually be reviewed by the 

institution conducting the research. In the DoD, 

extramural research and intramural research that is 

greater than minimal risk must also receive a 

“headquarters-level” administrative review. This 

additional review requirement is unique to the DoD, 

and arises from paragraph 5.3.3. of Department of 

Defense Directive 3216.02.

19(pp6-7)

Laboratory commanders at the US Army Medical 

Research and Materiel Command (USAMRMC) have 

the authority, after IRB approval, to approve minimal 

risk research. The Commanding General (CG), 

USAMRMC, has the authority to approve the use of 

human subjects in other research studies. The Human 

Subjects Research Review Board (HSRRB) serves 

under the CG’s authority. The HSRRB functions as an 

IRB for certain categories of research, and performs 

the headquarters-level review function for other 

research, which must first have been reviewed and 

approved by an IRB. The HSRRB has authority to 

recommend CG approval of research, and may also 

disapprove, or defer approval of the protocol. It may 

also recommend approval of the submitted protocol 

conditionally, requiring modifications or extra 

protections. In addition, the HSRRB may suspend or 

terminate an ongoing study. For research within the 

Clinical Investigation Program, the Clinical 

Investigation Regulatory Office (CIRO), recently 

relocated under the USAMRMC, provides the 

headquarters-level second review. For research, 

development, test, and evaluation (RDTE) work for 

which the HSRRB serves as the IRB, the Army 

Human Research Protections Office provides 

headquarters-level review. 

An institution conducting research must first determine 

if an activity in question is “research involving human 

subjects” under the Common Rule, as the Common 

Rule and its requirement for IRB review do not apply 

to activities that do not meet that definition. In 

addition, even if a given activity is determined to be 

research involving human subjects, the research may 

be exempt from the Common Rule, and therefore 

exempt from IRB review. A commonly cited 

exemption is research involving the collection or study 

of existing data, documents, records, or specimens, if 

sources are publicly available or if the information is 

recorded by the investigator in such a manner that 

subjects cannot be identified. The determinations of 

applicability of the Common Rule and/or exemption of 

research from the Common Rule can be made by the 

institution in whatever manner it deems appropriate. 

However, if there is even a possibility that a given 

activity may be nonexempt research involving human 

subjects, it is advisable to involve the IRB or the 

institutional office with human subjects protection 

expertise in both determinations. 

One of the tasks of the IRB is to determine the level of 

risk of the research. The risk levels are minimal risk 

and greater than minimal risk. The Common Rule 

defines minimal risk as the level of risk in which 

probability and magnitude of harm or discomfort 

anticipated in the research are not greater in and of 

themselves than those ordinarily encountered in daily 

life or during the performance of routine physical or 

psychological examinations or tests. An analysis of 

risk should include any risks unique to the study and 

an estimation of their severity and likelihood of 

occurrence. The risks presented in the protocol should 

be compared with risks the subject might encounter in 

the course of his or her daily activities. The risk level 

is relevant because it may affect the IRB and 

headquarters-level review processes; a medical 

monitor is not required for minimal risk research, and 

certain minimal risk research can be conducted with a 

waiver of informed consent. 

In addition to reviewing the informed consent 

document, the IRB, CIRO, and the HSRRB will also 

review the entire protocol to ensure that the risks to the 

subjects are minimized and in proportion to the importance of the knowledge to be gained. Selection of subjects will also be reviewed to confirm that the pool of 

subjects is equitable. Recruitment documents and 

advertisements will be reviewed to ensure that the 
38 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

study is not misrepresented to potential volunteers. Although the IRB and headquarters-level review do not 

include an independent scientific review, the reviews 

do consider scientific merit in the risk-benefit analysis. 

SPECIAL ISSUES 

Women and Minorities 

The FDA and the National Institutes of Health (NIH) 

guidance encourages diversification in clinical trials 

unless there is a scientific reason for excluding a 

certain category of human subjects.26 The FDA has 

stated that subjects included in clinical studies should, 

in general, reflect the population that will receive the 

drug when it is licensed and marketed. Representatives 

of both genders should be included in clinical trials in 

numbers adequate to allow detection of clinically 

significant gender-related differences in drug responses. It is the policy of NIH that women and members of minority groups must be included in all NIHfunded research, unless a clear and compelling rationale and justification establishes that inclusion is inappropriate with respect to the health of the subjects or 

the purpose of the research. Cost is not an acceptable 

reason for exclusion except when the study would 

duplicate data from other sources. Women of childbearing potential should not be routinely excluded 

from participation in clinical research.27 Similarly, 

inclusion of minorities in research studies is needed to 

obtain valid analyses of whether test variables affect 

members of minority groups differently. With the passage of the National Defense Authorization Act for 

Fiscal Year 1994,28 the DoD adopted the essential 

elements of the NIH guidance. The DoD now requires 

the inclusion of women and minorities in DoD funded 

or conducted research. 

Vulnerable Populations 

Certain categories of study subjects, such as children, 

incompetents, and prisoners, constitute “vulnerable” 

populations for whom special protections are warranted. As a general principle, research studies should 

use subjects that are considered less vulnerable before 

recruiting more vulnerable populations for participation, unless the research is specifically intended to 

benefit the vulnerable population being recruited, and 

the vulnerable population must be involved in order 

for the research to be successfully conducted. 

Children and Incompetents 

As previously mentioned, research directed at a specific category of subjects must seek to answer a 

specific scientific question pertaining to that group. 

For instance, children would be appropriate subjects 

for research on infectious diseases that afflict mostly 

children. The DoD, through Department of Defense 

Directive 3216.02,

19 requires compliance with HHS 

regulation 45 CFR 46, Subpart D (Additional 

Protections for Children Involved as Subjects in 

Research). This regulation specifies that the minor’s 

assent (in addition to the parent or legal 

representative’s consent) should generally be obtained 

if the minor is capable of understanding the object of 

the research study and the procedures to be performed. 

As an additional protection for minors and incompetents, DoD researchers are bound by the provisions of 

10 USC §980, discussed above. This law states, in 

relevant part: 

Funds appropriated to the Department of Defense may 

not be used for research involving a human being as an 

experimental subject unless ... in the case of research 

intended to be beneficial to the subject, the informed 

consent of the subject or a legal representative of the 

subject is obtained in advance.20

Because research involving children requires the 

consent of the child’s legal representative, as opposed 

to consent of the child, who cannot legally consent, the 

research must intend to benefit the child. Certain 

research that does not intend to benefit each minor 

subject would be approvable under the HHS subpart 

D, in the absence of 10 USC §980. 

The required intent to benefit of 10 USC §980 can be 

met if (1) the test article, drug, vaccine, or device is 

intended to benefit subjects who receive it; or (2) there 

are other intended benefits to subjects from the research, such as medical diagnostic testing, health care 

given during the research, psychological counseling, or 

nutritional analysis. There must be an intended benefit 

for each individual subject. It is not necessary for each 

subject to receive the same benefit, and it is 

permissible for some subjects to benefit more than 

others.* The IRB that is reviewing the research is the 

appropriate body for determining whether there is an 

intended benefit, and whether that intended benefit is 

sufficient. An intended benefit must at a minimum be a 

Biomedical Research Involving Human Subjects 

*Memorandum from MAJ Dale Woodling, Office of The Judge Advocate General, US Army, dated September 1, 1998. Available at 

the Office of the Staff Judge Advocate, US Army Medical Research and Materiel Command, Fort Detrick, MD. 
 January – March 2010 39

THE ARMY MEDICAL DEPARTMENT JOURNAL

medical benefit, as differentiated from compensation 

that may be provided to research subjects. 10 USC 

§980 has made it challenging, though not impossible, 

to conduct certain placebo research involving children, 

because investigators must demonstrate that such 

research intends to benefit each subject, including 

those who receive the placebo. 

Prisoners 

Although there is no per se prohibition on the use of 

prisoners as human subjects, studies proposing to use 

prisoners are controversial and should be carefully 

reviewed. DoD has conducted some research involving 

prisoners, and specifically adopted Subpart C of the 

HHS regulations which governs research involving 

prisoners. However, prisoners of war will not be used 

as research subjects.19(p3) Although prisoner 

populations may be very attractive to researchers 

because of their standardized living environment and 

availability for long-term studies, those populations 

may be susceptible to coercion or unstated pressures to 

volunteer or continue in a research study. 

Soldiers as Subjects 

Soldiers may also be considered a vulnerable 

population because of the special command authority 

and restrictions on autonomy imposed by the military 

environment. Soldiers may have the misperception that 

they will receive preferential treatment, good 

performance reports, or other benefits if they volunteer 

to serve as subjects. Alternatively, they may volunteer 

because they fear disapproval or retaliation for failure 

to participate in a command sponsored study. 

However, participation in any study must be truly 

voluntary and there are no Uniform Code of Military 

Justice28 or administrative actions for declining to 

participate in or withdrawing from a study. 

Recognizing the influences of the military command 

structure, paragraph 4.4.4. of Department of Defense 

Directive 3216.02, generally prohibits presence of 

officers and noncommissioned officers at group 

recruitment briefings of Soldiers under their command. 

Furthermore, provision for a disinterested ombudsman 

may be required to monitor group recruitment of 

service members to ensure that the voluntary nature of 

participation is stressed.19(p4) 

Others Who Require Special Protection 

Other groups face similar pressures or misconceptions 

concerning participation in clinical studies supported 

or conducted by their organizations. For example, 

medical and nursing students may feel pressure to 

volunteer for studies conducted by their teaching 

hospitals. Persons with advanced terminal diseases 

may be more vulnerable to recruitment for riskier 

protocols as a “last hope.” Indigents as a group also 

require special protection as they may have weakened 

physical and mental conditions, economic 

disadvantage, and generally, lack any family or 

community support in decision-making. 

Medical Care 

With regard to medical care for research-related 

injuries, the Common Rule merely requires subjects to 

be informed if medical care is available, and what 

costs may be involved. Such medical care, if available, 

may be billed to the subjects or subjects’ insurance and 

need not be provided free of charge.30 However, 

pursuant to paragraph 5.3.4. of Department of Defense 

Directive 3216.02,

19(p7) DoD components must 

“protect human subjects from medical expenses (not 

otherwise provided or reimbursed)” that are for 

treatment of research-related injuries from research for 

which primary involvement is from the DoD. 

Given the lesser requirement of the Common Rule and 

the inability of the federal government under fiscal law 

principles to commit to paying indefinite medical care 

costs, this provision has created some conflict with 

extramural research partners. It has also created some 

uncertainty within the DoD for components 

conducting intramural research involving human 

subjects who are not DoD health care beneficiaries. 

The DoD components interpret and address this 

provision in different ways. For example, the 

USAMRMC instructs extramural partners to include, 

after their own Common Rule policy, language in their 

consent forms informing subjects of the availability of 

no-cost medical care at Army medical treatment 

facilities, in accordance with Army Regulation 70-25 16

and paragraph 3-56 of Army Regulation 40-400,

31 and 

of a process to seek reimbursement (nonguaranteed) 

for out-of-pocket, research-related medical expenses 

incurred. Other DoD component mechanisms for 

attempting to meet this requirement include limiting 

enrollment to subjects who are DoD healthcare 

beneficiaries, and/or seeking DoD component 

Secretary designee status on an ad hoc or categorical 

basis for injured subjects who are otherwise not 

entitled to DoD healthcare. 
40 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

COMPENSATION RELATED TO PARTICIPATION

It is permissible for research subjects to receive 

payments or other compensation for participating in a 

study. Acceptable compensation includes, but is not 

limited to, reimbursement for transportation costs, 

other minor or incidental expenses, inconvenience 

associated with participation, and blood draws. 

Unacceptable compensation would be that which 

seems excessive, unwarranted, or appears to be an 

improper reward to obtain compliance. Compensation 

that would normally be acceptable may become an 

unacceptable inducement for a particular person or 

vulnerable group. Individual situations and cultural 

considerations must be evaluated in determining 

whether a particular payment is an improper 

inducement to participation or at what point a payment 

might become an improper inducement. 

Ability to compensate military service members for 

research participation has been a source of confusion. 

A federal law, 24 USC §30 (2002), permits compensation for blood draws, not to exceed $50 per blood 

draw, to be paid to "on-duty" service members (ie, 

when the service member is not on leave, and is 

participating during his or her duty hours). A service 

member who is participating while on-duty may only 

be compensated for blood draws, and may not be 

otherwise compensated for research participation. By 

permitting compensation for blood draws while onduty, 24 USC §30 provides an exception to another 

federal law, the Dual Compensation Act of 1964,32

which prohibits service members from being paid by 

any source other than their regular military salaries 

while they are on duty. 

“Off-duty” service members (service members on 

leave, or participating after his/her duty hours) may be 

compensated in the same manner as nonmilitary 

research subjects. Off-duty service members therefore 

may be paid more than $50 per blood draw and may be 

compensated for research participation generally (not 

only for blood draws). However, payment to off-duty 

service members for research participation other than 

blood draws must not be directly from a federal source 

(payment from a contractor or other nonfederal source 

is permissible). In addition, within the Clinical 

Investigation Program as regulated by Army 

Regulation 40-38, compensation of off-duty service 

members may still be limited to $50 per blood draw, 

with no distinction drawn between on duty and offduty participants for the purpose of compensation.24(p7)

Service members should get command permission to 

participate in research while off-duty. Participation in 

off-duty research may affect a service member's ability 

to perform his or her military duties. Principal investigators should confirm that a service member's commander supports the service member's research 

participation. 

SPECIMEN DONATION

If blood, tissue, or body product samples will be drawn 

during the study, the subject should be informed as to 

the procedures by which the specimen will be 

obtained, the amount of tissue or fluid withdrawn, and 

its use. Withdrawal of blood, for example, should be 

described in lay terms such as “two teaspoons worth.” 

If specimens will be obtained in the study for possible 

future use in another protocol, the informed consent 

document should include a statement notifying the 

subject of this possibility, and providing an option to 

permit or forbid such use. The consent document 

should also notify the subject that the specimen could 

potentially have some commercial applicability, but 

also include language that explicitly donates the 

specimen to the federal government and relinquishes 

all right, title, and interest in the specimen. 

CONFIDENTIALITY AND RECORDKEEPING

Records pertaining to the use of volunteer subjects 

should include a copy of approved consent documents, 

a copy of the approved research protocol, minutes of 

the IRB review, the commander’s recommendations, a 

summary of the research results including any adverse 

event reporting, and records compiled for the volunteer 

database. In addition, there will often be identifiable 

medical information related to the subject, either from 

a subject’s existing medical records, or created by the 

subject’s participation in research . 

For intramural RDTE research involving greater than 

minimal risk, and some other research projects, information about research subjects is entered into a volunteer registry database. The database contains personal 

information about the individual such that a subject’s 

questions about his or her participation in a particular 

research study can be answered. In addition, the database is necessary to ensure that the research organBiomedical Research Involving Human Subjects 
 January – March 2010 41

THE ARMY MEDICAL DEPARTMENT JOURNAL

ization can comply with its obligation to adequately 

warn volunteers of risks and to provide relevant new 

information as it becomes available. A statement must 

be included in the consent form for research as to 

which information will be entered into the database, 

notifying the subject that personal information will be 

collected, the purpose for collection, and duration of 

time the information will be maintained in the database. The subject must also be notified that representatives of the DoD and FDA (if research is regulated 

by the FDA) may inspect the records of the research in 

fulfilling their duty to protect human subjects. 

The extent to which records will be kept confidential 

must also be addressed. If the subject is a Soldier, 

notice must be given that complete confidentiality 

cannot be guaranteed, as certain medical conditions 

must be reported to the Soldier's commander or others. 

Any system of records must comply with Army 

Regulation 340-21,

33 the Army Privacy Program, and 

the Privacy Act of 1974.34

In addition, the Health Insurance Portability and Accountability Act35 (HIPAA) Privacy Rule regulates the 

use and disclosure of individually identifiable health 

information, and in the context of research this generally requires an “authorization” to use and/or disclose 

such information. The authorization can be integrated 

into or separate from the consent form. The DoD regulation that implements HIPAA is Department of 

Defense 6025.18-R.

36 Army Regulation 40-66 37 also 

discusses HIPAA. 

LIABILITY ISSUES

Feres Doctrine 

The Feres case generally precludes successful suits by 

service members for personal injury or death that is 

incurred incident to service.38 Medical malpractice 

cases are generally dismissed because medical care in 

military facilities is considered incident to service, 

even if the treatment or surgery was elective. A suit 

brought for personal injury or death resulting from 

participation in a research study would have certain 

similarities to a medical malpractice case and would 

most likely be barred if brought by a service member. 

Tort Litigation 

Suits arising from participation in DoD-conducted 

research studies would most likely be filed pursuant to 

The Federal Tort Claims Act (FTCA) which waives 

sovereign immunity to suit in certain limited cases.39

The FTCA does not prohibit suits for injury or death 

resulting from the negligence of government 

employees in conducting the research study. However, 

a plaintiff would have to prove that his or her injury is 

the proximate result of participation in the study and 

that some duty had been violated. Litigation would 

most likely concern issues of informed consent and the 

adequacy of the informed consent document. 

Specifically, allegations might assert inadequate 

disclosure of risks of personal injury or death. Causes 

of action may also be asserted that research or 

commercial interest in specimens was not disclosed or 

that the investigator was influenced in his treatment of 

the subject by a conflict of interest. There might also 

be claims resulting from the personal injury or death 

itself. Although the informed consent document may 

generate litigation, if drafted properly the document 

may serve as written evidence that the subject was 

warned of and acknowledged the risks associated with 

his or her participation in the study. 

Cobbs v Grant,

40 a California medical malpractice 

case, discussed the evolution of the negligence theory 

for inadequate disclosure and failure to obtain 

informed consent. Legal analysis in previous cases 

employed a battery theory instead of a negligence 

theory. The Cobbs court concluded that a battery 

theory should apply only when the procedure 

implemented is substantially different from the 

procedure consented to. The court also stated that 

inadequate disclosure of risks is really a question of 

the standard of professional conduct. The “patient’s 

dependence upon and trust in his physician for the 

information upon which he relies during the decisional 

process raises an obligation in the physician that 

transcends arms-length transactions.” The court held 

that an integral part of the physician’s obligation to the 

patient is a duty of reasonable disclosure of the 

available choices with respect to proposed therapy and 

of the dangers inherently and potentially involved in 

each alternative. Recognizing the difficulty of defining 

“reasonable,” the court went on to state that the scope 

of a physician’s communication to the patient must be 

measured by the patient’s need, and that need is 

whatever information is material to the decision. 

Therefore, the test for determining whether a risk must 

be disclosed is its materiality to the patient’s decision. 

The standard of disclosure was also addressed in Karp 

v Cooley,

41 a Texas medical malpractice case involv-
42 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

ing an experimental heart pump. The plaintiff alleged 

lack of informed consent because the number of animals in which the device was tested and the results of 

those tests were not disclosed. The plaintiff also 

claimed that the risk of injury by the mechanical heart 

and its experimental nature was never disclosed. The 

court stated that the standard of disclosure was what a 

reasonable practitioner of the same school of practice 

and the same or similar locality would have advised a 

patient under similar circumstances. The court also 

stated that 

Physicians and surgeons have a duty to make a reasonable disclosure to a patient of risks that are incident to 

medical diagnosis and treatment...True consent to what 

happens to one’s self is the informed exercise of a 

choice, and that entails an opportunity to evaluate 

knowledgeably the options available and the risks 

attendant upon each. 

Failure to disclose research or commercial interest in 

specimens or investigator conflicts of interest is 

another area ripe for litigation. In Moore v The Regents 

of the University of California et al,

42 the plaintiff’s 

cells were extracted and used to create a cell line with 

potentially lucrative commercial applications. The 

plaintiff was never told that his cells were being 

extracted for any purpose other than treatment; neither 

was he told that there might be some economic interest 

associated with the use of his cells. The court stated 

that a reasonable person would want to know whether 

his physician has an economic interest that might 

affect the physician’s professional judgment. The court 

held that the plaintiff was not required to prove that his 

cells had potential commercial value at the time they 

were extracted. The court also held that 

...a physician who is seeking a patient’s consent for a 

medical procedure must, in order to satisfy his fiduciary 

duty and to obtain the patient’s informed consent, disclose personal interests unrelated to the patient’s health, 

whether research or economic, that may affect his 

medical judgment. 

Failure to disclose such interests would give rise to a 

cause of action for negligence. 

CONCLUSION

Use of human subjects in research poses unique ethical 

questions that become more perplexing as biomedical 

technology increases in complexity and sophistication. 

The amalgam of ethical considerations, international 

common law, statutes and regulations protecting 

volunteer subjects is also becoming more complex. 

Scientists must seek to understand the necessity for 

enforcing protections for human subjects while 

devising new ways to solve scientific conundrums. 

Ethicists must endeavor to understand the importance 

of research in advancing knowledge. Regulators must 

be conscious of the shared objectives and competing 

concerns of both groups. A balancing of all interests 

must continue for successful development of new 

therapeutic drugs, devices and preventative vaccines 

for the benefit of all. 

REFERENCES

1. Annas GJ. The Rights of Patients: The Basic ACLU 

Guide to Patient Rights. 2nd ed. Carbondale, IL: 

Southern Illinois University Press; 1989. 

2. 21 CFR 50.3(c) (2009). 

3. Federal Food, Drug, and Cosmetic Act, 21 USC §355

(d) (2009). 

4. Human Subject Institutional Review Board 

Guidebook. Office for Human Research Protections. 

Washington, DC: Dept of Health and Human Services; 1993: chap 2. Available at www.hhs.gov/ohrp/

irb/irb_guidebook.htm. Accessed December 1, 2009. 

5. 45 CFR 46.116, Subpart A (2008). 

6. Annas GJ. Mengele’s Birthmark: The Nuremberg 

Code in United States Courts. J Contemp Health Law 

Pol. 1991;7:17-20. 

7. Annas GJ. Legal Issues In Medicine: Changing The 

Consent Rules For Desert Storm. New Engl J Med. 

1992;326:770-773. 

8. United States v Stanley, 483 US 669 (1987). 

9. World Medical Association Declaration of Helsinki; 

Ethical Principles for Medical Research Involving 

Human Subjects. Ferney-Voltaire, France: World 

Medical Association; 2008. Available at: http://

www.wma.net/en/30publications/10policies/b3/

index.html. Accessed December 3, 2009. 

10. International Ethical Guidelines for Biomedical 

Research Involving Human Subjects. Geneva, 

Switzerland: Council for International Organizations 

of Medical Sciences; 1993. Available at: http://

www.cioms.ch/frame_guidelines_nov_2002.htm. 

11. The National Commission for the Protection of 

Human Subjects of Biomedical and Behavioral 

Research. The Belmont Report: Ethical Principles 

and Guidelines for the Protection of Human Subjects 

of Research. Washington, DC. April 18, 1979. 

Available at: http://www.fda.gov/ohrms/DOCKETS/

ac/05/briefing/2005-4178b_09_02_Belmont%

20Report.pdf. Accessed December 4, 2009. 

Biomedical Research Involving Human Subjects 
 January – March 2010 43

THE ARMY MEDICAL DEPARTMENT JOURNAL

12. Pub L 95-622,12 92 Stat 3412 (1978). 

13. Executive Order 12975 of October 3, 1995: 

Protection of Human Research Subjects and Creation 

of National Bioethics Advisory Commission. 60 

Federal Register 52063 (1995). Available at: http://

frwebgate6.access.gpo.gov/cgi-bin/PDFgate.cgi?

WAISdocID=946206431230+1+2+0&WAISaction=r

etrieve Accessed December 4, 2009. 

14. Executive Order 13237 of November 28, 2001: 

Creation of the President’s Council on Bioethics. 66 

Federal Register 59851 (2001). Available at: http://

frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?

dbname=2001_register&docid=fr30no01-151.pdf. 

Accessed December 4, 2009. 

15. 32 CFR 219.117 (2009). 

16. Army Regulation 70-25: Use of Volunteers as 

Subjects of Research. Washington, DC: US Dept of 

the Army; January 25, 1990. 

17. 32 CFR §219.116 (2009). 

18. 56 Federal Register 28022 (June 18, 1991). 

19. Department of Defense Directive 3216.02: Protection 

of Human Subjects and Adherence to Ethical 

Standards in DoD-Supported Research. Washington, 

DC: US Dept of the Army; March 25, 2002. 

20. 10 USC §980 (2004), Limitation on the Use of 

Humans as Experimental Subjects. Available at: 

http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?

dbname=browse_usc&docid=Cite:+10USC980. 

Accessed December 7, 2009. 

21. Pub L No.107-107, 115 Stat 1012 Sec 733 (2001). 

Available at: http://frwebgate.access.gpo.gov/cgi-bin/

getdoc.cgi?dbname=107_cong_public_laws&docid 

=f:publ107.107.pdf. Accessed December 7, 2009. 

22. 21 CFR §50.24 (2009), Exception from Informed 

Consent Requirements for Emergency Research. 

Available at: http://www.accessdata.fda.gov/scripts/

c d r h / c f d o c s / c f c f r / C F R S e a r c h . c f m ? C F R 

Part=50&showFR=1. Accessed December 3, 2009. 

23. Waiver of Informed Consent Requirements in Certain 

Emergency Research, 61 Federal Register 51531-

51533 (1996) (codified at 45 CFR Part 46). 

24. Army Regulation 40-38: Clinical Investigation 

Program. Washington, DC: US Dept of the Army; 

September 1, 1998. 

25. Army Regulation 40-7: Use of US Food and Drug 

Administration-Regulated Investigational Products in 

Humans Including Schedule I Controlled Substances. 

Washington, DC: US Dept of the Army; October 19, 

2009. 

26. NIH Revitalization Act of 1993, 42 USC §289 

(1993). Available at: http://grants.nih.gov/grants/

olaw/pl103-43.pdf. Accessed December 1, 2009. 

27. NIH Policy and Guidelines on the Inclusion of 

Women and Minorities as Subjects in Clinical 

Research. US Dept of Health and Human Services 

Web site. Available at: http://grants.nih.gov/grants/

funding/women_min/guidelines_amended_10_ 

2001.htm. Accessed December 1, 2009. 

28. Defense Authorization Act for Fiscal Year 1994, Pub 

L No. 103-106, 107 Stat 1578 (1993). 

29. 64 Stat. 109, 10 USC, chap 47. 

30. 32 CFR 219.116(a)(6) (2009). 

31. Army Regulation 40-400: Patient Administration. 

Washington, DC: US Dept of the Army; February 6, 

2008:30. 

32. Dual Compensation Act of 1964, 5 USC §3501-3504. 

33. Army Regulation 340-21: The Army Privacy 

Program. Washington, DC: US Dept of the Army; 

July 5, 1985. 

34. The Privacy Act of 1974, 5 USC §552a (1974). 

35. Health Insurance Portability and Accountability Act, 

Pub L No.104-91 110 Stat 1936 (1996). 

36. DoD 6025.18-R: DoD Health Information Privacy 

Regulation. Washington, DC: US Dept of Defense; 

January 24, 2003. 

37. Army Regulation 40-66: Medical Record 

Administration and Healthcare Documentation. 

Washington, DC: US Dept of the Army; June 17, 

2008 [revised March 18, 2009]. 

38. Feres v United States, 340 US 135 (1950). 

39. The Federal Tort Claims Act, 28 USC §2671 (2006). 

40. Cobbs v Grant, 8 Cal 3d 229 (1972). 

41. Karp v Cooley, 493 F 2d 408 (1974). 

42. Moore v. The Regents of the University of California 

et al, 51 Cal 3d 120 (1990). 

AUTHOR

Mr Maleson is an Attorney Advisor with the Office of 

the Staff Judge Advocate, US Army Medical Research 

and Materiel Command, Fort Detrick, Maryland. 
44 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

INTRODUCTION

The Medical Affirmative Claims (MAC) Program is 

an excellent source of revenue for the medical facility 

for costs incurred due to care rendered to a Department 

of Defense (DoD) beneficiary who was injured as the 

result of a third party. The MAC program collects the 

cost of care arising from care rendered at the military 

treatment facility (MTF), from TRICARE* liens, and 

from lost wages of service members who were unable 

to fulfill government duties due to their injuries. This 

program is administered by local legal offices, under 

the jurisdiction of the US Army Claims Service 

(USARCS) and is described in detail in Army 

Regulation 27-20.

1

This article describes the applicable laws, jurisdiction, 

and mechanics of the MAC program at the MTF level. 

For more in-depth information on specific case issues, 

the higher headquarters for technical oversight is 

USARCS at Fort Meade, Maryland. Reporting MAC 

claims can be done at the MTF’s servicing legal office 

or, if at a smaller medical facility, at the servicing 

consolidated legal office. 

APPLICABLE LAWS

Recovery Sources. The MAC program is primarily 

based on the Federal Medical Care Recovery Act 

(FMCRA)2

 which was originally enacted in 1962. The 

FMCRA specifically covers tort-feasor liability. (A 

tort-feasor is a person causing injury or legal harm to 

another.) The program has been expanded through 

case law to also include 10 USC §1095 3 which allows 

recovery from “no fault” insurance. 10 USC §1095 is 

also the basis for the Third Party Collections Program 

to bill other health insurance. However, its application 

within the MAC program is to allow billing of medical 

care to “no fault” forms of insurance or other 

applicable coverage. 

Statutes of Limitation. 28 USC §2415 (2002) 

summarizes the applicable statutes of limitation 

(SOL). FMCRA third party liability SOL is 3 years. 

However, when dealing with “no fault” provisions of 

insurance such as personal injury protection or uninsured motorists, the SOL may be extended to 6 years. 

State laws also overlap somewhat into the MAC program. Actions asserted on a third party beneficiary 

basis against an insurer or against state labor and industries cases must comply with the applicable state 

law SOL in order to receive payment. In many cases, 

this can be as little as one year. Therefore it is 

imperative that MAC cases be reported to the servicing 

legal office as soon as they are known by the medical 

provider. 

Subrogation and Attorney’s Fees. Attorney’s fees or 

subrogation provisions arising in state law do not 

apply to the MAC program. FMCRA gives the 

government a “separate statutory right of action,” and 

the government is not bound by the signature or 

settlement of the claimant in any way. Any payment to 

the patient by the insurance company does not 

extinguish the government’s lien or independent right 

of action. Therefore, notice of a MAC claim should 

always be asserted directly to the insurance company 

or other source of payment, as well as to the patient’s 

attorney. Additionally, state law provisions of pro rata 

sharing of patient’s attorneys fees are also inapplicable 

to the federal government’s lien.4 

JURISDICTION

Exclusions. The jurisdiction of the MAC program is 

specifically for all DoD beneficiaries when they are 

injured by a nonfederal source. This includes active 

duty personnel, retirees, and all dependants. Bills for 

civilian emergency care, Veteran’s Administration 

patients, and intra-agency patients are billed by the 

hospital treasurer and are outside the scope of 

FMCRA. The tort-feasor who caused the injury to the 

DoD beneficiary must be a nonfederal source. A 

Soldier, retiree, or family member injured by another 

person’s personally owned vehicle is asserted as a 

MAC claim. A Soldier injured by a military convoy 

The Medical Affirmative Claims Program 

Melissa W. Hartley, JD 

*TRICARE is DoD’s healthcare program for members of the uniformed services, their families, and their survivors. Information 

available at http://www.tricare.mil. 
 January – March 2010 45

would generally not be asserted. Likewise, a premises 

liability case would depend on the status of the 

building where the injury occurred. 

Dollar Amount Jurisdiction. Dollar amount also affects 

jurisdiction for decisions on cases. Jurisdiction of 

cases at the local MAC office includes any case under 

$50,000. Any case with the potential to incur costs in 

excess of $50,000 is outside of local authority and 

must be coordinated with the USARCS. A mirror file 

of the entire case, along with a memorandum of 

recommendations must be forwarded to USARCS. 

Cases that are expected to exceed $100,000 should be 

sent to USARCS but the Department of Justice will 

have decision authority on all compromise and waiver 

requests stemming from that claim. All cases should 

be reported to the local servicing consolidated legal 

office, and will then be processed accordingly. 

Service Affiliation. Service affiliation can also affect the 

jurisdiction of a claim. Generally, Army beneficiary 

cases will be asserted by the MTF but other service 

beneficiaries will be billed and transferred to the 

servicing legal office for their branch of service. 

Jurisdictional lines of many cases may currently be 

affected by realignment of some clinics by local 

BRAC* agreements. Jurisdiction of a case can also be 

worked out with the other service or MTF on a case-by

-case basis based on the location of attorneys, 

witnesses, and where the majority of care occurred. 

Often, Army MAC offices may also negotiate transfer 

of a case within the Army when one MTF has the 

majority of medical care or liens. Upon settlement, 

money is divided into pro rata shares to all MTF 

accounts or TRICARE, based on where the actual care 

is rendered. However, the patient or patient’s attorney 

has one primary point of contact to deal with 

throughout the FMCRA process. 

MECHANICS OF THE PROGRAM

Identification of Claims. The identification of MAC 

cases takes work and communication between a legal 

office and the MTF staff. Cases can be identified 

through the coding of the patient encounter or reported 

by clinic staff based on the patient’s medical history 

given at the time of the visit. Reporting MAC cases to 

the servicing legal office is within the allowable 

exceptions for release under applicable HIPAA laws.5,6

Military police blotters and civilian newspapers are 

good sources for recovery of TRICARE cases. Legal 

correspondence from outside sources can also help to 

identify MAC claims. The request from the patient’s 

attorney for records from the patient administration 

division (PAD) office should be held until the MAC 

office is given notice. In many cases, the MAC office 

can assert bills along with the records request so that 

an insurance settlement is not made before the 

government’s lien is asserted. Requests to the MTF 

legal office for medical witness testimony are often a 

sure sign of litigation in a MAC claim. 

INDIVIDUAL CASE SCENARIOS

Motor Vehicle Accidents (MVA). The bulk of MAC cases 

are motor vehicle accidents which are usually tort 

liability cases asserted against the third party tortfeasor’s insurance policy.2

 This is often a patient who 

has been hit by another driver, but may be a patient 

who was a passenger in another person’s vehicle. 

Recovery sources can also be found with patients 

injured in their own car while another family member 

was driving or with policies of the owner of a “borrowed” car. The patient’s own policy may have a separate pedestrian clause or other provision covering him 

or her if he or she is injured in the roadway or parking 

lot.3

 The third party liability carrier is generally the 

largest source of recovery, but will also generally take 

the longest to settle and pay the MTF. Assertion 

should be made to all insurance carriers because the 

patient’s own car insurance may have medical payment or personal injury protection provisions that will 

pay immediately. This payment source is generally exhausted quickly by civilian providers such as chiropractors or other care providers not generally covered 

by TRICARE. Products liability issues with tires or 

brakes, negligent highway barrier design, and other 

types of recovery are often available to the plaintiff. 

Premises/Product Liability. Other types of MAC cases 

arise from premises or product liability. Premises 

liability cases are usually “slip and falls” and are 

asserted against the building owner’s insurance. In 

order to assert a MAC claim, the building must be 

owned by a nonfederal source. Buildings owned by 

state government are a source of MAC claim covered 

by the FMCRA, but no federal buildings of any kind 

are covered. Products liability cases are generally 

*Base Closure and Realignment Committee – The congressionally authorized process for DoD to reorganize its base structure to 

more efficiently and effectively support forces, increase operational readiness, and facilitate new ways of doing business. 

Information available at: http://www.defenselink.mil/brac/faqs001.html 
46 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

recoverable unless it involves a military source. Many 

product liability cases involve injuries by toys, so 

pediatric and family practice physicians should be 

informed of toy recalls and of the MAC claims reporting mechanism utilized by the MTF. Recoverable 

injuries seen in MAC programs include injuries caused 

by such things as small parts, lead exposure in paint, 

magnets, and detachable buttons or small pieces on 

baby clothing. Other possible claims involving 

incidents such as food poisoning, dog bites, and mold 

exposure should also be identified and asserted. 

Worker’s Compensation. State worker’s compensation 

cases are determined by the status of the employer. A 

MAC claim may be asserted under 10 USC §1095 3 in 

the instance of an active duty service member injured 

while engaged in off-duty employment off post. 

Remember to look at the status of the off-duty 

employer, not of the patient. A MAC claim can be 

asserted if the employer is a private entity or a state 

government agency. If the employer is another federal 

source, a MAC claim would not be asserted. Retiree 

injuries may be recoverable as a MAC claim if their 

second career is with an employer other than a federal 

agency. Federal employee cases are not asserted. 

Medical Malpractice. Medical malpractice claims from 

nonfederal sources may also be recoverable. A MAC 

claim can be asserted if the patient is transferred to an 

MTF for a lengthy recovery process from prior 

malpractice, or if TRICARE expends coverage for 

revision surgery or other necessary followup. 

Recovery can be obtained through the patient’s civil 

litigation attorney or be asserted directly to the civilian 

hospital’s insurance carrier. Many of these cases are 

transferred from a civilian hospital via ambulance 

directly to the MTF surgical service, so efforts should 

be made to have MTF surgeons or medical staff report 

the case directly to the MAC office when the patient is 

received by the MTF. 

Criminal Restitution. Restitution cases come from a 

variety of sources. MAC cases are often identified by 

subpoenas. The civilian prosecutor’s office routinely 

sends subpoenas to the MTF for medical witness 

testimony.7

 If the care was rendered to a DoD 

beneficiary, the legal office can request restitution 

upon sentencing of the criminal defendant. These cases 

can be identified by requests to the PAD office for 

emergency room records or by law enforcement 

requests for records. In any criminal case, restitution 

claims can be submitted to the witness liaison or the 

prosecutor, and restitution can be ordered by the 

courts. Additionally, many states have specific laws 

for victims’ compensation programs that may offer 

additional “no fault” sources of recovery even if a 

criminal defendant is never actually charged. These 

would be state crime victims’ funds and differ 

depending on individual state law. 

PROCESSING THE CLAIM

Assertion and Collection. Exact procedures for assertion 

and collection are outlined in Army Regulation 27-20.

1

Timing is the key to successful recovery of funds for 

any MTF. Early identification of MAC claims and 

assertion to all available sources of recovery is a must. 

Timely updates for ongoing medical care and frequent 

contact by the legal office with plaintiff’s attorney or 

the recovery source is necessary to insure that a case is 

not settled without the government’s knowledge. 

MTFs can assist in the MAC recovery process by 

identifying and reporting claims, and providing timely 

responses to labor and industries forms requests or 

civil subpoenas, when coordinated by the servicing 

legal office. 

Waiver and Compromise. In cases of extreme hardship 

to the patient or when there are limited recovery 

sources, requests for compromise and waiver of the 

claim can be processed. The Regional Claims Settlement Officer (RCSO) for the servicing MAC office 

will process the request to ensure fairness to our DoD 

beneficiaries in instances when recovery funds are 

limited.1

 The RCSO has jurisdiction to decide requests 

for compromise or waiver of the government’s 

interest, if the case is less than $50,000. Larger cases 

must be processed by USARCS and those over 

$100,000 require approval of the Department of 

Justice. Numerous factors go into the decision process, 

including residual injuries of the patient, continued 

care at government expense, amount of recovery available, and any hardship circumstances of the patient. 

CONCLUSION

The Medical Affirmative Claims Program is an 

excellent opportunity to bring money to the Army 

military treatment facility. This money is deposited 

into the operation and maintenance fund of the MTF 

where the care was rendered. TRICARE also 

The Medical Affirmative Claims Program 
 January – March 2010 47

THE ARMY MEDICAL DEPARTMENT JOURNAL

contributes a percentage of TRICARE funds collected 

by the MAC office to the MTF through a new cooperative agreement. The money brought to the MTF 

enhances patient care and is also used for training and 

equipment for its staff. If your MTF does not have a 

strong MAC program, consultation with your servicing 

legal office or the MAC area action officer at the US 

Army Claims Service is highly encouraged. 

REFERENCES

1. Army Regulation 27-20: Claims. Washington, DC: 

US Dept of the Army; February 8, 2008. 

2. Federal Medical Care Recovery Act, 42 USC §2651-

2653 (2008). 

3. 10 USC §1095 (2009). 

4. 5 USC §3106 (2009). 

5. Department of Defense 6025.18-R: Health 

Information and Privacy Regulation. Washington, 

DC: US Dept of Defense; January 24, 2003. 

6. 45 CFR 164.512 (2004). 

7. Army Regulation 27-40: Litigation. Washington, DC: 

US Dept of the Army; September 19, 1994. 

AUTHOR

Ms Hartley is Deputy Center Judge Advocate, Madigan 

Army Medical Center, Tacoma, Washington, and the 

Regional Claims Settlement Officer for the Western 

Regional Medical Command. 

Crest of the Madigan Army Medical Center, 

Fort Lewis, Washington 
48 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

Adverse Privileging Action 

Denying, suspending, restricting, reducing, or revocation of clinical privileges based upon misconduct, 

professional impairment, or lack of professional competence. The termination of professional staff appointment 

based upon conduct incompatible with continued professional staff membership may also result in an adverse privileging action.1(p8) 

INTRODUCTION

In 1986, the US Congress determined that the increase 

in occurrence of medical malpractice was a nationwide 

problem, due in part to the fact that incompetent 

healthcare practitioners were free to move from state 

to state without discovery or disclosure of previous 

actions or censures.2

 Congress further determined that 

effective peer review could help remedy the healthcare 

quality problem, but that the threat of liability served 

to deter physicians and dentists from participating in 

peer review. Based upon these premises, Congress 

enacted the Health Care Quality Improvement Act of 

1986 (HCQIA),3

 a well-meaning attempt to improve 

the quality of health care in America. In addition to 

providing certain limitations on liability for healthcare 

entities and professionals involved in the peer review 

process, HCQIA provided for the establishment of a 

national repository of information pertaining to 

licensing board sanctions, medical malpractice 

payments, and adverse privileging actions involving 

physicians, dentists, and other privileged healthcare 

practitioners.4

This reporting system came to be known as the 

National Practitioner Data Bank (NPDB). The Health 

Care Quality Improvement Act’s reporting 

requirements and the potential availability, real and 

perceived, of the information contained in the NPDB 

generated legitimate concern among healthcare entities 

and professionals nationwide. Indeed, the reporting 

requirements now significantly affect the way 

hospitals and medical staffs manage the credentialing, 

privileging, and peer review processes. 

LEGAL AUTHORITIES APPLICABLE TO THE ARMY

MEDICAL DEPARTMENT

In addition to HCQIA accountability and reporting 

requirements, other guidelines applicable to adverse 

privileging in the AMEDD include the following, 

without limitation: 10 USC §1102 (governs treatment 

of information derived from quality assurance 

processes, including adverse privileging actions); The 

Joint Commission* guidelines (the Department of 

Defense (DoD) has mandated accreditation by The 

Joint Commission for all MTFs); Department of 

Defense [regulation] 6025.13-R,

1

 (opt-in to HCQIA, 

NPDB, and quality assurance processes); Army 

Regulation 40-68 5 (the Army regulation pursuant to 

above authorities); and individual MTF policies (local 

policy consistent with above authorities, such as 

committee structure and available privileges). 

Publication of a DoD manual to replace Department of 

Defense 6025.13-R is pending at this writing. The new 

DoD manual will describe the process and 

management of clinical adverse actions for privileged 

and nonprivileged healthcare providers and will apply 

Adverse Privileging Actions in the Army 

Medical Department 

Rosalind D. Gagliano, RN, JD, LLM 

ABSTRACT

Fully 23 years after enactment of the Health Care Quality Improvement Act and 19 years after initiation of 

the National Practitioner Data Bank reporting requirements, the identification and proper processing of 

adverse privileging actions continues to be a dynamic, challenging, and rights-preserving system at the 

forefront of the quality assurance initiatives, both within and outside of the Department of Defense. This article addresses the more pressing legal and practical implications of compliance in the adverse clinical privileging actions forum from the Army Medical Department military treatment facility command perspective.

*The Joint Commission (One Renaissance Blvd, Oakbrook 

Terrace, Illinois 60181) is a private sector, US-based, not-forprofit organization founded in 1951. The Joint Commission 

operates accreditation programs for a fee to subscriber 

hospitals and other healthcare organizations. 
 January – March 2010 49

to all MTFs in the Military Health System. In-depth 

discussion of HCQIA, 10 USC §1102, The Joint 

Commission accreditation requirements, and local 

MTF policies are beyond the scope of this article. 

CLINICAL PRIVILEGES

Clinical Privileges define the scope and limits of 

practice for individual providers, and are based on the 

capability of the MTF and the credentials of the 

provider.1(p8) A provider’s credentials include licensure, relevant training and experience, current competence, health status, judgment, and peer and department head recommendations.5(p45) The process of 

clinical privileging is the responsibility of the MTF 

commander, is usually discharged by the MTF 

credentials committee, and results in the grant of 

permission and responsibility to a healthcare provider 

to deliver specified or delineated healthcare within the 

scope of his or her license, certification, or registration 

in the MTF.1(p8),5(p26) AMEDD providers must apply 

for clinical privileges at the receiving MTF each time 

they transfer, and must apply for renewal every 2 

years. Every application for privileges or renewal of 

privileges triggers a requirement for the MTF to query 

the NPDB on the particular provider. NPDB 

information received by the querying MTF is not 

intended to be expositive of the competency or 

qualifications of a practitioner, but to serve as a 

flagging or alert system to supplement existing 

programs for reviewing the qualifications of 

practitioners.6

 The NPDB querying and reporting 

requirements apply to all healthcare entities, licensing 

agencies, and some healthcare societies in the United 

States. The wide-scale application is necessary to 

fulfill the Congressional intent of preventing incompetent or dangerous providers from freely moving to a 

different state or hospital, or continuing to endanger 

patient safety by moving from federal service to the 

private sector or vice-versa. In the AMEDD, any 

action by the privileging authority (MTF commander) 

to deny, suspend, restrict, reduce, or revoke privileges, 

based on the provider’s misconduct, impairment, or 

lack of professional competence is termed an adverse 

privileging action.1(p8) 

ADVERSE PRIVILEGING ACTIONS PROCESS

The AMEDD adverse privileging process delineated in 

chapter 10 of Army Regulation 40-68 5(pp71-93) is 

summarized in the Figure. Documents and testimony 

in connection with an adverse privileging action 

constitutes quality assurance information and, 

therefore, subject to the protections and prohibitions in 

10 USC §1102, chapter 2 of Department of Defense

[regulation] 6025.13-R,

1(pp21-23) and Appendix B of 

Army Regulation 40-68.5(pp128-130) The AMEDD 

process basically has 5 steps: abeyance or summary 

suspension, investigation, professional peer review, 

hearing, and appeal. Action taken by the commander 

or his/her delegate to hold in abeyance, to deny, or to 

summarily suspend clinical privileges is proper when 

there is reasonable cause to doubt the individual’s 

competence to practice or for any other cause affecting 

the safety of patients or others. Reasonable cause 

includes but is not limited to: a single incident of gross 

negligence; a pattern of inappropriate prescribing; a 

pattern of substandard care, negligence, or incompetence causing death or serious bodily injury; abuse 

of substance or diagnosis of alcohol dependence; 

documented impairment and refusal or failure by the 

individual to complete rehabilitation; a psychiatric 

disorder that is not responsive to treatment; and 

significant unprofessional conduct. Note that if an 

acute or chronic medical problem, mental health 

condition, or alcohol/drug impairment interferes with 

the provider’s performance of clinical duties, the 

provider will submit a request to appropriately modify 

his/her privileges or scope of practice. This modification is not considered an adverse privileging action, 

but is governed in accordance with chapter 11 of Army 

Regulation 40-68.

5(pp94-101) Although the responsibility 

for invoking and processing adverse actions lies 

primarily with the MTF commander, section 10-3 of 

Army Regulation 40-68 5(p72) requires consultation and 

coordination as follows: 

 With the servicing staff judge advocate prior to 

proceeding with any adverse privileging action, to 

help ensure that legal guidance is followed 

throughout the process. 

 With the regional medical command/regional 

dental command (RMC/RDC) for guidance on 

procedures and to discuss plan of action, since 

RMC/RDC is responsible for process oversight, 

and for appeals from MTFs. For appeals from 

medical centers or involving RMC/RDC 

personnel, the US Army Medical Command or 

Dental Command will provide oversight and serve 

as appellate authority. 

 With civilian personnel employee relations specialist prior to any adverse privileging action relative to a civil service employee, to ensure compliance with established civilian employee guidance. 
50 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

 With the appropriate contract officer if an adverse 

privileging action is being considered on a contract 

employee, to ensure compliance with the contract 

in place. 

 With US Army Medical Command (MEDCOM) 

Office of the Staff Judge Advocate (OSJA). 

Section 10-3c of Army Regulation 40-68,

5(p72)

requires that the MEDCOM OSJA review all 

adverse privileging/practice actions prior to final 

action by The Surgeon General. 

ABEYANCE/SUMMARY SUSPENSION

The commander must act when a provider’s conduct, 

condition, or performance requires action to protect the 

health or safety of patients. In situations where the 

threat to patient safety or the incompetence is not 

clearly defined, the commander, deputy commander 

for clinical services, or the provider’s department chief 

may place the provider’s privileges in abeyance. An 

abeyance is not an adverse action, but formally places 

Adverse Privileging Actions in the Army Medical Department 

Discovery, Event, Complaint, or Suspicion 

Summary suspension not greater 

than 15 days and optional 15-day 

extension in writing, 30 days total 

Report findings and recommendations 

to Credentials Committee in writing. 

Report is reviewed. 

Are findings supported? 

Return to 

Status and 

destroy papers 

END

END 

No further appeal. 

DA Form 2499 to 

MEDCOM for 

possible report to 

NPDB. 

Peer Review 

3 providers: objective and similar background 

or specialty to provider under review. 

Notify provider of date of peer review and 

opportunity to submit a written statement. 

No right to appear or to attorney. 

Peer review determinations and 

recommendations. NO

YES

Credentials Committee 

recommendations thru ECMS to 

MTF commander who reviews and 

approves or disapproves. Written 

notification of decision and hearing 

rights info given to provider. 

Provider 

requests hearing? 

NO

Chapter 10, Army Regulation 40-68: 

Legal standard–Each finding must 

be supported by a preponderance of 

the evidence. 

Issue recommendations. 

YES

Written notice of decision and 

basis to Provider. 

Right to request 

reconsideration. 

Automatic appeal. 

MTF 

Commander 

Regional Medical 

Command for review 

MEDCOM 

Quality 

Management 

Division 

Office of the 

Staff Judge Advocate 

National Practitioner 

Data Bank 

State Agencies 

Request for 

Reconsideration 

Abeyance 

Clinical Quality Assurance Investigation 

Schematic representation of the Army Medical Department adverse privileging action process. 
 January – March 2010 51

THE ARMY MEDICAL DEPARTMENT JOURNAL

the provider on notice that scrutiny of his/her practice 

has begun which may result in an adverse privileging 

action or administrative action. The initial abeyance 

period is 15 days, and may be extended for an 

additional 15 days by the commander with written 

notice to the provider, if necessary for investigation 

and committee consideration. On the 31st day 

following initiation of an abeyance, the action 

becomes a summary suspension. Where the 

individual’s misconduct, professional incompetence, 

or negligence is obvious and poses a clear and evident 

threat to the safety of patients or well-being of others, 

a summary suspension of clinical privileges should be 

the initial course of action. Summary suspension of 

privileges is not an adverse privileging action, but 

signals the need for an investigation into the practice 

or conduct of the provider. Whether the initial action is 

abeyance or summary suspension, the provider is 

entitled to written notification specifying the basis for 

the initial action, naming the action, the duration of the 

action, and that a quality assurance (QA) investigation 

will be conducted and results reviewed by the 

credentials committee. Forms of written notice and the 

written provider acknowledgement are provided in 

Figures 10-1 and 10-2, respectively, of Army 

Regulation 40-68.

5(pp85-86) In the case of an abeyance, 

the MTF commander has discretion to withdraw 

permission for off-duty employment (ODE); however, 

withdrawal of permission for ODE and notification of 

the facility/clinic where the provider is engaged in 

ODE are mandatory for summary suspension cases. 

Further, there can be no approval of ODE applications 

until privileges are restored at the MTF. 

INVESTIGATION

Section 10-6d of Army Regulation 40-68 5(p75) requires 

an immediate and rigorous investigation to collect 

relevant facts and information in every case of 

abeyance or summary suspension. The MTF commander will appoint a disinterested third party to 

conduct the investigation and to report the results to 

the credentials committee or the appropriate 

department chief if the provider is not privileged. The 

investigating officer (IO) should be reminded that all 

information, testimony, findings, recommendations, 

and documentation connected with a QA investigation 

are quality assurance information, and any release is 

subject to 10 USC §1102 and Appendix B of Army 

Regulation 40-68 5(pp128-130) The QA investigation may 

include voluntary consultation with the provider in 

question, review of relevant documents, or discussions 

with individuals having knowledge of the situation. 

When the investigation is complete, the report 

submitted by the IO will present the factual findings 

with appropriate justification or details and may 

include the IO’s conclusions and recommendations. 

The MTF credentials committee (or credentials 

function) will review the IO’s report and other 

pertinent information and recommend one of the 

following to the commander: 

 No further action be taken (if available evidence 

did not warrant a privileging action) and the 

provider’s privileges be reinstated 

 Monitoring and evaluation 

 A formal peer review 

Monitoring and evaluation (M&E) is defined in the 

draft DoD manual as a well documented plan of 

intensified peer review to confirm a provider possesses the skill, knowledge, and ability to render safe 

and effective healthcare. The M&E documentation 

plan must include clear expectations and measures of 

success that will be routinely reviewed throughout the 

period of M&E. 

FORMAL PEER REVIEW

If the credentials committee’s recommendation for 

formal peer review is approved by the commander, the 

requirements in chapter 10-6f of Army Regulation 40-

68 5(p76) apply. Formal peer review is required 

whenever a standard of care determination must be 

made or if a provider’s performance is such that an 

adverse privileging/adverse practice action may be 

indicated. The intent of a formal peer review is to 

evaluate the provider’s performance, conduct or 

condition to determine the extent of the problem(s) and 

to make recommendations through the credentials 

committee to the commander. The provider must 

receive written notice of the date, time and location of 

the peer review; a statement of the alleged facts, 

events, conduct or omissions subject to review, the 

provider’s right to submit a written statement, and the 

rights of appearance as set out in section 10-6f(2) of 

Army Regulation 40-68.

5(p76) The conclusions reached 

by the peer review panel should be supported by 

rationale that specifically addresses the issues for 

which the peer review was conducted. 
52 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

The peer review panel must be composed of at least 3 

clinical peers of the involved provider, meaning they 

possess similar clinical specialty, education and 

training. If the MTF does not have 3 peers available to 

conduct this review, it may be accomplished using 

peers from other MTFs, and the meeting may occur in 

person or via video or teleconference. The following 

are not appropriate participants as voting members of a 

peer review panel: 

Neither the provider’s direct supervisor, nor the 

provider’s subordinates 

The individual who suspended the provider’s 

privileges 

Any person who investigated the case (including 

the IO) 

Any person whose testimony is expected to be 

significant in the case 

Any person who is participating or has participated 

in any other administrative proceeding or courtsmartial board involving the provider 

Any person who is reviewing or has reviewed the 

provider’s actions under consideration 

The credentials/risk management committee 

chairperson 

The peer review panel may make one of the following 

recommendations: reinstatement, monitoring and 

evaluation (M&E), suspension, restriction, reduction, 

revocation, or denial. The array of recommendations 

are further defined in Chapter 10-6f(5) of Army 

Regulation 40-68.

5(p75) Within 7 calendar days of 

completing the peer review, the panel’s recommendations, along with the evidence considered, will 

be forwarded to the credentials committee. The credentials committee will include its recommendation(s), 

which may or may not coincide with those of the peer 

review panel, and the entire case file with recommendations will be forwarded to the commander. 

The commander has 14 calendar days from receipt of 

the recommendations to review and decide what 

privileging action to take based on the facts provided. 

Although not bound by the recommendations of the 

credentials committee or the peer review panel, the 

commander’s decision must be supported by the facts 

of the case. The commander must provide written 

notice to the provider of the privileging action to be 

taken and the justification, addressing all specified 

allegations. A form of notification is at Figure 10-4 of 

Army Regulation 40-68.

5(p89) If the provider is a 

contract provider, a copy of the notification is 

forwarded to the responsible contracting office, and a 

letter documenting the actions is provided to the 

contractor at the address of record. If the proposed 

action is other than reinstatement or M&E, the 

provider must also be advised in writing of his/her 

hearing and appeal rights. The provider must have 

access to all information considered by the credentials 

committee and the MTF which resulted in the basis of 

the preliminary action. 

REQUEST FOR HEARING AND WAIVER

Section 10-7b of Army Regulation 40-68 5(p78) currently 

requires the provider to request a hearing in writing to 

the credentials committee chairperson within 10 duty 

days from the date of receipt of the notification of 

recommended adverse privileging action. This time 

frame will likely be changed to not less than 10 nor 

greater than 30 calendar days when the DoD manual is 

published. The provider may voluntarily waive his/her 

right to a hearing by not requesting a hearing within 

the specified time frame, or by failure to appear at a 

scheduled hearing, absent good cause as determined by 

the commander. Note that if the provider is unable to 

appear in person at the hearing, alternate means of 

obtaining his/her personal participation will be offered 

to include written deposition or telephone conference 

call. Waiver of hearing rights includes waiver of 

appeal rights. When a hearing is waived, the 

recommendations from the credentials committee and 

peer review panel are forwarded to the commander for 

review and decision. The written decision and the 

provider’s notice of the commander’s decision will be 

filed in the provider credentials file, with appropriate 

forwarding through the regional medical command to 

MEDCOM Quality Management Division for 

reporting to The Surgeon General, and possibly the 

NPDB. 

HEARING BOARD NOTIFICATION AND COMPOSITION

The Deputy Commander for Clinical Services or other 

physician designated by the commander will chair the 

hearing board. The chairperson will advise the 

provider in writing, delivered in person, with provider 

receipt acknowledged by signed memorandum of the 

following: 

Adverse Privileging Actions in the Army Medical Department 
 January – March 2010 53

THE ARMY MEDICAL DEPARTMENT JOURNAL

a) The adverse privileging action under 

consideration that is the grounds for the 

hearing, any specific dates, facts and all 

pertinent documents applicable to the case. 

b) The time and location of the hearing. 

c) The names of the witnesses who will be called 

to testify at the hearing. 

d) The provider’s right to be present, to submit 

evidence, to question witnesses and to provide 

witnesses on his/her behalf. 

e) The right to have legal counsel present. 

The notice requirement is discussed more fully in 

section 10-8 of Army Regulation 40-68,

5(pp78-80) and a 

form for provider notification of hearing is provided at 

Figure 10-6.5(pp91-92)

The hearing board composition may be a subset of the 

credentials committee, or the entire credentials 

committee may perform this function, according to 

local MTF policy, subject to the following 

requirements. The IO and any member of the peer 

review panel may not be a voting member of the 

hearing board, and at least one voting member of the 

hearing board must be a privileged provider from the 

same discipline as the provider requesting the hearing. 

HEARING BOARD PROCEDURES

The hearing will be fair and impartial, and is intended 

to provide a thorough review of the material presented, 

including that submitted by the provider. The fair 

hearing is an administrative proceeding; therefore, the 

rules of evidence prescribed for trials by courts-martial 

or in courts of law are not applicable. The chairperson 

will serve as presiding officer of the hearing board and 

as such, will open the hearing, ensure the orderly 

presentation of evidence and timely progression of the 

proceeding, dismiss any unruly person, rule on any 

objections, and will only vote in the event of a tie. If 

criminal misconduct by the provider, including 

dereliction of duty, is known or suspected, the 

chairperson will advise the provider of his/her rights, 

using Department of the Army Form 3881 (Rights 

Warning Procedure/Waiver Certificate). The hearing is 

closed to the public, however, the provider may 

request that the chairperson permit observers. The 

chairperson will normally grant the request but may 

limit the number of observers and may exclude anyone 

who is disruptive to the proceedings, at the chair’s 

discretion. The chairperson should issue a reminder to 

all involved at the opening of the hearing that the 

hearing is considered a QA activity covered by 10 

USC §1102 and information from the proceedings is 

not for release by any individual. Additionally, no 

recording devices, other than that used by the 

designated recorder to prepare the record, are 

permitted in the hearing. Witnesses will be called in to 

the hearing room to provide their testimony and 

answer questions from the hearing board and the 

provider, and will then be excused from the hearing 

room. After the presentation of all evidence and 

relevant information, the provider and his or her 

representatives will be excused, and the hearing board 

will deliberate in closed session to determine its 

findings and recommendations. 

In addition to tape recording, the hearing will be 

documented in summarized minutes that reflect all the 

salient details of the proceedings. The documentation 

must show that each of the hearing board’s findings is 

supported by a preponderance of the evidence, in other 

words, each finding must be supported by a greater 

weight of evidence than supports a contrary conclusion. Specific incidents or situations will support 

general statements by the hearing board. To substantiate the findings of the hearing board, copies of 

pertinent medical and/or dental records or case histories will be included in the record of the proceedings. 

Recommendations by the hearing board may include, 

but are not limited to: 

 Reinstatement of privileges 

 Identification of specific provider deficiencies that 

require improvement and the establishment of 

requirements such as consultation with other 

providers or specialists related to patient care 

management 

 Suspension, reduction, or restriction of clinical 

privileges for a specified length of time, including 

a recommendation that the provider be released 

from active duty or federal employment 

 Revocation of clinical privileges 

 Reconvene the hearing, after appropriate notice to 

the provider, to consider additional relevant 

evidence. 
54 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

The decision of the hearing board is determined by 

vote of the majority. Following deliberation, each 

hearing board member will cast a vote by secret ballot, 

either for the findings and recommendations or against 

them. Abstention is not permitted. 

The record of the hearing, including the findings and 

recommendations, will be reviewed by the executive 

committee of the medical staff (ECMS) prior to 

forwarding to the MTF commander. All qualified 

members of the ECMS (excluding hearing board 

members, the investigating officer, and peer review 

panel members) will either concur by endorsement 

with the recommendations of the hearing board or 

submit separate recommendations. If an ECMS 

member is absent and unable to review the hearing 

board report, the absence will be noted and the case 

forwarded to the commander without endorsement by 

the absent member. The servicing staff judge advocate 

will review the record, including credentials 

committee/peer review panel findings and 

recommendations and any input from the provider for 

legal sufficiency prior to action by the commander. 

The commander will review the hearing record and 

make a decision regarding the provider’s privileges. 

The hearing board’s findings and recommendations are 

advisory only, and not binding on the commander. 

Written notice of the commander’s decision, with the 

date of delivery annotated on it, will be furnished to 

the provider either in person or by certified return 

receipt requested mail. The signed receipt 

acknowledges the provider’s receipt of the 

commander’s decision. If the commander decides to 

deny, suspend, restrict, reduce, or revoke the 

provider’s privileges, the written notice should advise 

the provider of his or her right of appeal, and that the 

provider will be given a copy of the hearing record 

upon request. The written notice of the commander’s 

decision should specify that the provider has 10 duty 

days to submit a request to the commander for 

reconsideration. The commander may extend the 10 

duty day time limit in writing at the request of the 

provider for good cause. A copy of the notice will be 

placed in the provider’s provider credentials file and 

the appropriate department, service, or clinic chief will 

be advised of the decision. 

RECONSIDERATION AND APPEAL

The burden is on the provider to specify the grounds 

for reconsideration and appeal. If the provider does not 

request reconsideration, the adverse privileging action 

and all information pertaining to the case will be 

submitted to the MEDCOM Quality Management 

Division, with copy furnished to the regional medical 

command for reporting to the NPDB. If the provider 

elects to appeal the commander’s decision, he/she will 

submit a formal request that identifies the errors of fact 

or procedure that form the basis of the request. The 

commander has 14 calendar days to consider the 

request for reconsideration. If the commander denies 

the request in whole or in part, the action is 

automatically endorsed to The Surgeon General as an 

appeal. The Surgeon General is the final appellate 

authority for denying, suspending, restricting, reducing, or revoking clinical privileges. The written appeal 

and all information pertaining to the case will be 

submitted through the commander of the appropriate 

regional medical command or regional dental 

command (RMC or RDC) using certified mail (return 

receipt-requested). The RMC or RDC commander will 

review the packet to ensure all necessary information 

is included prior to forwarding the case to the 

appropriate staff office that will conduct the appeal. If 

the appeal involves medical center, RMC, or RDC 

providers or commanders, the MEDCOM Quality 

Management Division will convene the appeals board. 

Otherwise, the RMC or RDC is responsible for 

convening appeals boards from the subordinate MTFs. 

APPEALS PROCESS

The appeals board will consist of a minimum of 3 

privileged providers, one of whom will serve as 

chairperson and all of whom will be voting members. 

At least one member of the appeals board should be of 

the same discipline and specialty as the provider 

whose appeal is under consideration. If the provider is 

a dentist with no medical facility privileges, the 

appeals board will consist of 3 dental officers. If the 

dentist has medical facility privileges which are under 

review, the committee will include one privileged 

physician and 2 dental officers, one with medical 

facility privileges, if possible. If the action is against a 

dental officer with hospital privileges, but the action 

involves only the dental privileges, the appeals board 

will consist of 3 dental officers. 

The standard for the appellate review is whether there 

is substantial evidence to support the MTF 

commander’s decision. After evaluating the merit of 

the appeal in light of the provider’s basis for appeal 

Adverse Privileging Actions in the Army Medical Department 
 January – March 2010 55

THE ARMY MEDICAL DEPARTMENT JOURNAL

and considering all information in the record, the 

appeals board will advise the convening commander 

(MEDCOM, US Army Dental Command, RMC, or 

RDC, as appropriate) of its findings and 

recommendations for disposition, and whether it finds 

substantial evidence to support the MTF commander’s 

adverse privileging action. Findings and 

recommendations of RMC-level appeals will be 

endorsed by the RMC commander and all documents 

considered by the appeals board will be forwarded by 

certified return receipt requested mail to the 

MEDCOM for review and approval by The Surgeon 

General, the sole authority responsible for provider 

notification of the final decision associated with an 

appeal. No other party has input into that final 

decision. The appellate authority will notify the 

provider of the decision on the appeal by certified 

return receipt requested mail as soon as possible 

following adjournment of the appeals board. The RMC 

or MTF commander, as appropriate, will also be 

notified in writing, with clear guidance as to what 

actions the MTF is expected to take regarding the 

future utilization of the provider. 

Of note is that any subsequent administrative action to 

separate a provider as a result of an adverse privileging 

action must be deferred pending appeal resolution. 

Providers who voluntarily separate prior to resolution 

of their appeal must be informed in writing that the 

process will be completed as though they were still on 

active duty or employed in a civilian capacity. Only 

The Surgeon General is authorized to report AMEDD 

healthcare personnel to the appropriate professional 

regulating authorities, including the NPDB, the 

Federation of State Medical Boards, state licensing 

boards, and other regulatory agencies. 

REFERENCES

1. Department of Defense Regulation 6025.13-R: 

Military Health System (MHS) Clinical Quality 

Assurance (CQA) Program Regulation. Washington, 

DC: US Dept of Defense; June 11, 2004. 

2. 42 USC §11101(2) (1988). 

3. 42 USC §§11101-11152, as amended by Omnibus 

Budget Reconciliation Act of 1989, Pub. L. No. 101-

239, sec 6103(e)(6)(A, 103 Stat.2106, 2208). 

4. 42 USC §§11131-11137. 

5. Army Regulation 40-68: Clinical Quality 

Management. Washington, DC: US Dept of the 

Army; February 26, 2004 [revised May 22, 2009]. 

6. National Practitioner Data Bank Guidebook.

Rockville, MD: Health Resources and Services 

Administration, US Dept of Health and Human 

Services; September 2001. Available at http://

www.npdb-hipdb.hrsa.gov/npdbguidebook.html. 

Accessed February 1, 2010. 

AUTHOR

Ms Gagliano is Health Care Law Attorney-Advisor in 

the Office of the Staff Judge Advocate, Headquarters, 

US Army Medical Command, Fort Sam Houston, 

Texas. 
56 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

Intellectual property is a hot topic today. The world’s 

most successful companies recognize the enormous 

financial and competitive power that resides in an 

intellectual property portfolio. In our knowledge and 

technology based economy, the intangible products of 

the mind—inventions, original works of authorship, 

and know-how—have taken on paramount importance. 

The New York Times recognized that “intellectual 

property has been transformed from a sleepy area of 

law and business to one of the driving engines of a 

high technology economy.”1

 US Army Medical 

Command (MEDCOM) inventions play an important 

role in achieving the Army’s mission and the 

stimulation of the US economy. Inventions arising 

from the MEDCOM laboratories, hospitals, and clinics 

are often dual-use technologies—inventions useful for 

both the Warfighter and civilian sectors. This article is 

an introduction to some of the many federal laws and 

agency-specific regulations that govern the creation, 

protection, ownership, and transfer of intellectual 

property arising from federal research. 

BASIC INTELLECTUAL PROPERTY ASSETS

Patents, trademarks, copyrights, and trade secrets are 

considered to be the 4 main types of intellectual 

property (IP), defined as the intangible product of the 

human mind. Some say that it is imagination made 

real. IP is personal property, and like other personal 

property, it can be owned, used, given away, sold, or 

even “rented” under a license. It is an asset like 

equipment or investments, and should be protected 

from theft, misuse, and misappropriation. 

PATENT

A patent is a grant to the inventor by the federal 

government of a limited time right to exclude others 

from making, using, offering to sell, selling or 

importing the invention that is claimed in the patent 

document. A patent may be obtained for inventions 

comprising a process, machine, an article of 

manufacture, composition of matter, or any new and 

useful improvement thereof. Examples may include 

chemical compounds and processes, a process for 

purifying or expressing a protein, some types of 

software, medical diagnostic devices, medical 

imaging, vaccines, etc. Almost anything is patentable 

so long as the invention is new, useful, and unobvious 

when compared to what has come before. 

Improvements of existing inventions are also 

potentially patentable, such as a new use of a known 

process or compound. 

TRADEMARK

A trademark is a name, symbol, logo, combination or 

other device, including color and sound, that indicates 

the source and quality of goods and services and 

distinguishes those goods and services from those of 

competitors. “Made up” or arbitrary marks are stronger 

and confer more protection than descriptive marks. An 

example of a strong arbitrary mark is Apple 

Computers. The shape of a Coca Cola bottle is also a 

familiar trademark. Sounds like the MGM lion’s roar 

and the NBC chimes can also be trademarks, as can 

slogans like “you’ve got mail.” Colors like the pink of 

the Owens-Corning insulation can be used as a 

trademark identifying the source of that particular 

product. 

COPYRIGHT

Copyright protects original works of authorship such 

as writings, music, and works of art that have been 

tangibly expressed and fixed in some medium. 

Copyright protects the expression of an idea as that 

expression is embodied in the work, but not the idea 

itself. A copyright is an exclusive right to reproduce 

the copyrighted work, distribute copies of the work to 

others, perform or display the work in public, and 

prepare derivative works based upon the original work. 

In order to obtain a copyright, the work must be 

independently created and possess some degree of 

creativity. Purely factual works are not copyrightable. 

Reformatted works could be copyrightable if the level 

of creativity in the reformatting meets the copyright 

office standard. 

US Army Medical Command 

Intellectual Property 

Elizabeth Arwine, JD 

Jill Caldwell 
 January – March 2010 57

Works made by federal government employees as a 

consequence of their official duties are not 

copyrightable. The federal government can, however, 

hold and license copyrights that are assigned to it by 

those capable of obtaining copyright protection, such 

as contractors. If a work was authored jointly by a 

government employee and a nongovernment 

employee, those portions of the work authored by the 

government employee are not copyrightable. 

TRADE SECRET

A trade secret is information that an organization may 

choose to keep secret to give that organization an 

advantage over its competitors. It is generally technical 

or business information that possesses economic value 

from not being known to other persons who can derive 

economic value from its disclosure or use. 

Although the government does not possess its own 

trade secrets per se, government employees are 

responsible for protecting the financial or proprietary 

business information of current and potential vendors 

or collaborators. There are 2 federal acts pertaining to 

trade secrets, one that makes it a crime to steal trade 

secrets and one that makes it a crime for a federal 

government employee to release confidential or 

proprietary information gained during the course of his 

or her employment.2,3

PATENT LAW

An invention must be useful, novel, and nonobvious to 

be patentable. For example, if the inventor makes a 

new chemical but cannot identify a use for the 

chemical, he cannot obtain a patent. The invention 

must also be something new. It cannot have been 

already described in a printed publication, used, 

known, or patented. Finally, a patent cannot be 

obtained on an invention that, although novel, 

comprises elements that, when considered as a whole, 

results in an invention that would have been obvious to 

others working in that field at the time it was made. 

Note that this is a very general description of a 

complex legal concept. 

There are also events that, if they occur, prevent an 

inventor from obtaining a patent on his or her 

invention.4

 If an inventor publicly discloses his 

invention prior to applying for a patent (for example, 

publicly using it, presenting detailed information at a 

scientific conference or open meeting, publishing a 

journal article about it, demonstrating it, displaying it, 

or selling it), he may not be able to obtain a patent on 

that invention in the United States unless a patent 

application is filed within one year of the invention's 

public disclosure.5

 Inventors should consult a patent 

attorney if a public disclosure has been made. 

Determining whether patent rights have been lost is 

complicated and not all public disclosures are 

damaging. 

There are 3 types of patents: plant, design, and utility.

Plant patents protect invented or discovered, asexually 

reproduced new and distinct plant varieties. A design 

patent consists of the visual ornamental characteristics 

embodied in, or applied to, an article of manufacture. 

Design patents can be obtained for new, original, and 

ornamental designs for articles of manufacture. For 

example, the shape of a bicycle helmet, the look of an 

athletic shoe, and the pattern and shape of a lampshade 

can be protected by design patents. Utility patents 

protect the functional aspects of the invention. In 

general terms, a “utility patent” protects the way an 

article is used and works while a “design patent” 

protects the way an article looks. Applications for 

utility patents are the most common type of patent 

application filed for MEDCOM inventions. 

There are 2 types of utility patent applications: the 

nonprovisional and provisional applications. (Note: 

provisional patent applications may also be filed for 

plant patents.) A nonprovisional application, also 

known as a regular or nonprovisional utility patent 

application, begins the examination process and 

ultimately may lead to an issued patent. A provisional 

patent application establishes a filing date which is 

strategically important but does not begin the 

examination process. A provisional patent application 

will never result in a patent. It is generally used in 

emergency situations such as imminent public 

disclosure. A provisional application also provides the 

inventor with a one-year period to further develop the 

invention, determine marketability, acquire funding or 

capital, or seek licensing agreements. The regular 

patent application must be filed within one year of the 

provisional filing date in order to claim the benefit of 

that earlier filing date. 

PATENT APPLICATION SUBMISSION, EXAMINATION AND

TERM

Patents are obtained through a complex and usually 

lengthy administrative proceeding requiring a unique 

blend of scientific and legal skills to navigate. Scientist-patent attorney/agent partnerships are essential to 
58 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

successful patent prosecution. A patent application is 

the most complex and sophisticated of legal documents. The patent application is prepared by the patent 

attorney or patent agent with the assistance of the 

inventor, based upon the invention disclosure and all 

relevant information, publications, and patents 

available. Upon submission to the US Patent and 

Trademark Office (USPTO), the patent application is 

assigned to a patent examiner, who is deemed by the 

USPTO to be an expert in the technology covered by 

the patent application. The patent examiner will 

determine whether the application complies with legal 

requirements and if the invention is new, useful, and 

nonobvious. 

Under current law, the patent application will usually 

be published online by the USPTO about 18 months 

after the filing date. The application, examination 

correspondence, and issued patents are published on 

the USPTO website (www.uspto.gov). Searches of 

published patent applications and issued patents by 

various fields and keywords can also be conducted on 

that website. 

Utility patents have a term of 20 years, calculated from 

the filing date of the patent application. If, for 

example, 3 years pass in the examination process 

between filing of the application and issuance of the 

patent, the effective term of patent protection is 17 

years. The amount of time it takes for examination of 

an application depends upon many factors, including 

the nature of invention, the complexity of the 

invention, and the body of prior knowledge relevant to 

the invention. Today, on average, it takes from 2 to 5 

years for the examination and issuance of a patent. 

Mechanical inventions, for example, tend to move 

through the examination process more rapidly than 

chemical or biological related inventions. This may be, 

in part, because mechanical devices operate under 

known and predictable physical and mechanical 

principles. Chemical and biological inventions also 

operate under known physical laws (for the most part), 

but their mode of operation may not be as predictable 

as mechanical inventions. These applications usually 

take about 3 to 4 years to issue into patents. Software 

inventions tend to move through the process even 

more slowly as applications for software related 

inventions are very complex. It is not unusual for 

software applications to remain pending in the USPTO 

for 5 years or more. 

PATENTING EXPENSES

Obtaining a patent can be very costly. The costs of 

obtaining a patent depend upon, among other things, 

the complexity and length of the patent application, the 

difficulty encountered in obtaining an allowance 

during the examination process, the cost of patent 

attorney or agent services, patent office fees, and 

whether the patent application or patent is challenged. 

The services of patent attorneys and patent agents are 

expensive. Both patent attorneys and agents have 

scientific degrees but patent agents are not attorneys. 

Both are registered to practice before the USPTO, but 

patent agents may not represent an inventor in court, 

nor may a patent agent draft legal documents, such as 

assignments, for inventors. As a patent attorney has 

both a scientific degree and a law degree, the fees 

generally reflect these additional qualifications and 

expertise. 

OWNERSHIP AND ASSIGNMENT OF INVENTION

Patent applications are filed in the name of the federal 

government employee inventors, but the government, 

subject to exceptions, owns all the rights to any 

invention 

 made by any government employee during 

normal working hours, or 

 which bears a direct relation to or is made in consequence of the official duties of the inventor, or 

 to which the government contributed facilities, 

equipment, materials, funds, information, or time 

or service of other government employees on 

official duty. 

Government employee inventors who believe that the 

ownership of the invention should reside with them 

can request an invention rights determination. Even if 

the invention was made before the inventor became a 

government employee or it is clearly unrelated to his 

or her duties, it is wise to request and receive an 

invention rights determination in order to remove any 

potential cloud upon the title of the invention. 

Private sector employees are usually required by their 

employment contracts to assign all rights in any 

inventions they make to their employer. As different 

organizations have different policies, nongovernment 

employee inventors should always consult their 

employment contract to determine whether they are 

US Army Medical Command Intellectual Property 
 January – March 2010 59

THE ARMY MEDICAL DEPARTMENT JOURNAL

obligated to assign rights in the invention to their 

employer. 

PATENTS IN FOREIGN COUNTRIES

The patent grant provides protection and confers rights 

to a patentee only within the United States and its 

territories. If foreign protection and rights are desired, 

a patent must be obtained in the foreign country. There 

are alternative routes to obtaining patent protection in 

foreign countries. Note that foreign patents cannot be 

obtained if there has been any public disclosure of the 

invention before the application filing date. Only in the 

United States does an inventor have a one-year grace 

period between public disclosure and the filing of his 

or her patent application. Once the invention has been 

publicly disclosed, foreign rights are lost unless a 

patent application has already been filed for that 

invention. 

INTELLECTUAL PROPERTY RESULTING FROM FEDERALLY

FUNDED RESEARCH

The Bayh-Dole Act6 provides the statutory basis for 

federal technology transfer activities, including the 

patenting and licensing of inventions made under 

federal funding agreements by recipients of those 

funds. The Act applies to inventions made as a result 

of a federal funding agreement such as a grant, cooperative agreement, or contract. The Act permits recipients of federal funding to elect to take title to any 

invention that arises from performance of the federal 

funding agreement. If the recipient of the federal funding agreement elects to take title, the recipient must 

file patent applications, seek commercialization opportunities, and report to the funding agency on its efforts 

to obtain use of the invention. In return, the government shall have a nonexclusive, nontransferable, irrevocable, paid-up license to make or practice the invention or have the invention made or practiced on behalf 

of the United States. The government may make or use 

the invention that was made under the federal funding 

agreement. In addition, the government may have the 

invention made or used for it by other parties as long 

as these actions are for the government’s benefit. The 

government, however, may not grant licenses for 

commercial exploitation of the invention. 

The right of the recipient of federal funding to take 

title is conditioned upon fulfilling its obligations under 

the Bayh-Dole Act in a timely fashion. The recipient 

must report the making of and disclose the invention to 

the government within a reasonable time after the 

recipient’s inventor discloses the conception or making 

of the invention to recipient’s representative 

responsible for the administration of patent matters.7

The Bayh-Dole Act does not define “reasonable time,” 

but corresponding Federal Acquisition Regulation 

(FAR) provisions require reporting of the invention to 

the government within 2 months after the inventor 

reports it to his or her employer.8

 Electing title and 

filing patent applications are also subject to time 

constraints identified in the FAR.9

 If the recipient of 

federal funding elects to take title to the invention, the 

federal agencies generally require the recipient to 

execute a document confirming this license to the 

government which is filed at the USPTO. If a recipient 

of federal funding declines to take title or fails to meet 

their Bayh-Dole obligations within the time limits 

provided, the government may take title to the 

invention, and has on occasion done just that.10,11

INTELLECTUAL PROPERTY ARISING FROM COOPERATIVE

RESEARCH AND DEVELOPMENT AGREEMENTS

A Cooperative Research and Development Agreement 

(CRADA) is a written agreement establishing a 

collaborative research relationship between a federal 

laboratory and a partner. The CRADA partner can be a 

person or an entity from industry, state government, 

local government, academic institutions, nonprofit 

organizations, or another federal laboratory.12 A 

CRADA allows the federal government and nonfederal 

partners to optimize their resources, share technical 

expertise, develop and share intellectual property 

arising from the collaborative effort, and speed the 

commercialization of federally developed technology. 

A CRADA may provide protection for any proprietary 

information brought into the CRADA relationship by 

the partner. The terms of a CRADA may also allow 

parties to the CRADA to keep research results 

confidential and free from disclosure through the 

Freedom of Information Act13 for a certain period of 

time. A CRADA permits the government and the 

partner to share in intellectual property rights. A 

federal laboratory may provide IP, with or without 

direct reimbursement. The federal laboratory may contribute federally owned patents, trademarks, copyrights, information, or know-how to the collaborative 

effort. A nonfederal CRADA partner may also provide 

the same types of IP. 
60 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

All types of intellectual property can arise from the 

collaborative effort. However, data and inventions tend 

to be the most common products resulting from a 

CRADA. The rights and obligations of the parties with 

respect to data and intellectual property are usually set 

out in the terms of the original CRADA, or a 

subsequent amendment or modification to the 

CRADA. The terms of the CRADA control the 

disposition of the intellectual property. However, other 

laws such as the patent or copyright statutes and case 

law may affect the disposition of those intellectual 

property rights. For these reasons, the terms of the 

CRADA must be interpreted in light of other 

applicable statutes, regulations, or case law. 

LICENSING OF FEDERALLY OWNED INVENTIONS

The federal government’s policy promotes the full utilization of government-owned inventions by licensing 

inventions to the private sector. Licensing of federally 

owned inventions and other intellectual property is 

effected through a license. A patent license agreement 

(PLA) is a contractual agreement granting the right to 

use or practice a government-owned invention in 

exchange for something of value, usually royalties and 

other payments. Inventions described in issued patents 

and/or patent applications, both domestic and foreign, 

may be licensed under a PLA by the federal facility. 

Main Types of Licenses 

Each federal agency is authorized to grant 

nonexclusive, exclusive, or partially exclusive licenses 

to federally owned inventions, royalty-free or for 

royalties or other consideration on such terms and 

conditions as determined appropriate in the public 

interest.14 A license does not transfer ownership of the 

invention or other intellectual property being 

licensed—the federal agency remains the owner of the 

intellectual property. A license is only a promise by 

the licensor not to sue the licensee for actions 

performed by the licensee that are within the scope of 

the license agreement.15

A nonexclusive license permits the licensee to practice 

the invention or other intellectual property described in 

the licensed patent or patent application. The licensor 

(the government in this case) will still retain the ability 

to practice the invention. In addition, the licensor may 

also license the invention or other intellectual property 

to another licensee, thus the term “nonexclusive.” A 

true exclusive license allows only the exclusive 

licensee to practice the invention or other intellectual 

property. The patentee may not practice the invention, 

nor may he license another to do so. Many “exclusive” 

licenses reserve to the owner of the intellectual 

property a right to practice the invention. Because 

there are no other third-party licenses, this type of 

license is referred to as an “exclusive” license. A 

partially exclusive license may be directed to specific 

geographic areas of use, to specific fields of use (home 

or hospital), to various markets for a product (retail or 

wholesale), or for limited periods of time less than the 

full term of the patent. A licensee might receive 

exclusive license rights in his particular industry, 

whereas another licensee might receive exclusive 

license rights in her different, unrelated industry. A 

partially exclusive license allows the licensor to create 

license revenue without generating competition 

between the licensees or in the patentee’s own market. 

Terms and Conditions for All Licensees 

The terms of the PLA are usually negotiated by 

representatives from the federal laboratory’s Office of 

Research and Technology Applications. The terms and 

conditions (financial and otherwise) included in the 

PLA will depend on many factors. The licensor and 

licensee should consider the stage of development of 

the technology being licensed, whether the license is 

for a single invention or a patent portfolio, whether the 

invention requires regulatory approval (for example, 

new drugs are regulated by the US Food and Drug 

Administration), the potential end user market (for 

example, the need for the product, commercial 

potential, and the size of the market), and the 

licensee’s ability to finance, manufacture, and market 

the invention. Although there is a certain amount of 

flexibility regarding the terms and conditions that will 

be placed into a PLA, there are certain terms and 

conditions that are required by statute or regulation. 

(Note: The Secretary of Commerce is authorized to 

promulgate regulations specifying the terms and 

conditions upon which any federally owned invention, 

other than inventions owned by the Tennessee Valley 

Authority, may be licensed on a nonexclusive, 

partially exclusive, or exclusive basis.16) With respect 

to all licenses, the government must retain a royaltyfree, irrevocable license to practice and have practiced 

the invention on behalf of the United States. 

INCENTIVES FOR GOVERNMENT LABORATORIES AND

INVENTORS

In addition to stimulating future research and 

development collaborations with the private sector, a 

US Army Medical Command Intellectual Property 
 January – March 2010 61

THE ARMY MEDICAL DEPARTMENT JOURNAL

PLA has the potential to result in products that the 

government needs. For example, licensing of 

Department of Defense inventions may result in better 

products for the Soldiers, Marines, Sailors, and 

Airmen. A PLA may also generate much needed 

income for the federal laboratory. A federal laboratory 

may take 80% of any royalties it receives from a PLA 

and use those funds as the director deems appropriate. 

Many laboratories reinvest those funds in research and 

development, purchase needed supplies, services, or 

training. A PLA may also facilitate the government’s 

access to improvements of the licensed invention or 

other intellectual property. By licensing technology, 

the potential exists for development of alternative or 

supplemental sources of goods and services to the 

government. Finally, PLAs enhance the prestige of the 

federal laboratory and its scientists. 

A portion of the royalty income received through the 

PLA goes to the government employee inventors of 

the licensed invention. The government coinventors 

can receive up to 20% of any royalties received by the 

federal laboratory. There is a limit of $150,000 in 

royalties that any single government inventor can 

receive in any given year. The cumulative cap of 

$150,000 covers all inventions of a particular inventor 

that may be licensed. Of the royalties received by the 

federal laboratory, the first $2000 goes immediately to 

the government inventors. Note that government 

employee inventors cannot participate in PLA 

negotiations concerning the financial aspects of the 

license as that is a conflict of interest. The government 

employee inventor can, however, provide input 

concerning commercial potential and technical aspects 

of the invention. 

CONCLUSION

The MEDCOM has a significant domestic and foreign 

patenting program that has resulted in many licensed 

inventions that are used in hospitals, clinics, and 

laboratories or by private sector companies. Many 

other inventions are in advanced development for 

regulatory approval and transition into the private 

sector. This article only touches upon some of the 

many facets of intellectual property practice and 

generalizes highly complex concepts. 

REFERENCES

1. Chartrand S. Patents; a federal agency, in transition, 

reaches out to independent inventors with a new 

department. The New York Times. April 5, 1999:C2. 

Available at: http://www.nytimes.com/1999/04/05/

business/patents-federal-agency-transition-reachesindependent-inventors-with-new.html. Accessed 

January 11, 2010. 

2. 18 USC §§1831-1839. 

3. 18 USC §1905. 

4. 35 USC §102. 

5. 35 USC §102(b),(d). 

6. The Bayh-Dole Act, 35 USC §§200-212 (1980). 

7. 35 USC §202(c)(1). 

8. Federal Acquisition Regulation, 48 USC Part 27.3 

(2004). 

9. 35 USC §202(c)(2)-(c)(3). 

10. 35 USC §202(c)(2). 

11. Burgett D. Feature comment: federal circuit upholds 

patent forfeiture for failure to comply strictly with 

reporting requirement, despite lack of prejudice. The 

Government Contractor. 2004;46(44). Available at: 

http://www.ncura.edu/content/educational_programs/

sites/49/handouts/docs/Monday130/M130F7.pdf. 

Accessed January 11, 2010. 

12. 15 USC 3710a(a)(1). 

13. Freedom of Information Act, 5 USC §552 (2007). 

14. 35 USC 207(a)(2). 

15. Brunsvold BG. Drafting Patent License Agreements. 

4th ed. Washington, DC: The Bureau of National 

Affairs, Inc; 1998. 

16. 35 USC §208. 

AUTHORS

Ms Arwine is Chief Patent Attorney and Intellectual 

Property Counsel at the Office of the Staff Judge 

Advocate, US Army Medical Research & Materiel 

Command (USAMRMC), Fort Detrick, Maryland. 

Ms Caldwell is Patent Paralegal at the Office of the 

Staff Judge Advocate, USAMRMC. 
62 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

INTRODUCTION

Medical personnel in the US military are extensively 

educated, trained, and experienced professionals 

whose expertise is in high demand. These individuals 

are often invited to attend scientific or medical conferences, to present papers, to give presentations, or to 

provide technical instruction to, or collaborate with, 

nonfederal entities (NFEs). Such private entities are 

often professional associations, medical supply companies, potential technical transfer partners, universities, and other hospitals. These entities are frequently willing to provide airfare, lodging, and meals 

for the invitee in exchange for the invitee’s expertise. 

Acceptance of travel benefits by government 

employees is governed by several statutes and 

regulations. The overall purpose of these statutes and 

regulations is to ensure that government employees are 

not placed in a position where they could potentially 

be influenced in the performance or nonperformance 

of their official duties. 

ACCEPTANCE OF OFFICIAL TRAVEL BENEFITS IN-KIND

OR PAYMENT FOR OFFICIAL TRAVEL EXPENSES

In general, official travel by government employees is 

funded by the federal government except that government employees in the US military may accept travel 

benefits (including in-kind subsistence, accommodations, and payments or reimbursements of expenses) from NFEs as provided in 31 USC §1353, 41 CFR 

Part 304, and chapter 4 of the Department of Defense

(DoD) Joint Ethics Regulation (JER).1(pp45-54) Chapter 

4 of the JER does not apply to travel benefits provided 

to US military employees in their personal capacities, 

however, employees must report such travel expenses 

in personal financial disclosure reports as required in 

accordance with chapter 7 of the JER.1(pp79-91) There 

may also be limitations on the acceptance of travel 

benefits in one’s personal capacity, including 

restrictions on acceptance of gifts from prohibited 

sources, those given because of the employee’s federal 

position, as well as under 41 USC §423. 

Government employees in the US military may also 

accept travel and travel-related expenses from a 

foreign government. Criteria used to determine 

whether it is appropriate to accept travel expenses of 

more than “minimal value” may be found at 5 USC 

§7342, DoD Directive 1005.13,

2

 and JER, paragraph 

2-300b.1(p26) This amount is adjusted every 3 years and 

is currently set at $335 (as of January 1, 2008). 

Payment of such expenses may be accepted if travel 

begins and ends outside the United States, except 

when travel across the United States is the shortest, 

least expensive, or only available route. Such travel 

must be in the best interests of the US military and the 

US government, considering all the circumstances. 

Acceptance procedures are straightforward. All official 

travel benefits accepted from NFEs must be approved 

in writing by the travel-approving authority, upon the 

advice of an ethics counselor and approved in advance 

of travel, if accepted under the authority granted by 31 

USC §1353, in accordance with 41 CFR 304-3.12 and 

JER, paragraph 4-100c(2).1(p45) However, acceptance 

may be authorized after the travel has begun if a 

number of criteria are met in accordance with 41 CFR 

304-3.13. The latter procedure is often very difficult 

and should be avoided if possible by acquiring 

approval in advance of the travel. 

Gifts of Travel Benefits from Nonfederal 

Sources to Military and Civilian Government 

Employees 

MAJ Joseph B. Topinka, JAG, USA 

This article is based on material developed by COL Samuel Smith, former Center Judge Advocate, Walter Reed Army 

Medical Center, and LTC (Ret) Margaret Schulyer, former Judge Advocate, US Army Medical Research and Materiel 

Command, Fort Detrick, Maryland. The subject material was included in a deskbook used in military legal conferences and presentations, and for online reference purposes. The Author
 January – March 2010 63

In accordance with 31 USC §1353, the JER, Federal 

Travel Regulations (41 CFR 300-304), and 41 CFR 

301-1.2 and 304, travel expenses can be accepted by 

US military employees in connection with their 

attendance in an official capacity at “a meeting or 

similar function.” 

Government employees may not generally accept 

travel benefits from a prohibited source as it could 

cause a reasonable person to question the integrity of 

government operations. A prohibited source is an 

entity whose interests may be substantially affected by 

the performance or nonperformance of a given 

employee’s duties.3

 Army ethics counselors serve a 

vital role in conducting an analysis to determine 

whether an NFE can be classified as a prohibited 

source. Factors considered in this analysis include: 

The identity of the NFE. 

The purpose of the meeting or event. 

The nature and sensitivity of any matter pending at 

the agency which may affect the interest of the 

NFE (which includes a check of the current 

Department of the Army contractor list). 

The significance of the employee’s role in any 

such matter. 

The monetary value and character of the travel 

benefits offered by the NFE. 

Acceptance of official travel benefits from nonfederal 

sources for attendance at meetings or similar functions 

requires the concurrence of an ethics counselor. A 

sample of a memorandum to document the nonfederal 

entity offer to provide travel benefits to Department of 

the Army personnel, and concurrence or nonconcurrence by the ethics counselor is provided on page 

66. The standard for analysis is whether a reasonable 

person with knowledge of all relevant facts could 

conclude that the travel is for an official purpose and is 

for attendance at a qualifying meeting or other similar 

function. The employee’s attendance at the meeting or 

function must be appropriate and consistent with the 

interests of the organization. 

US military employees (including their spouses) cannot accept cash travel payments or checks made out to 

the employees on behalf of the federal government. 

When travel benefits are reimbursed rather than provided in-kind, payments from the nonfederal source 

will be by check or similar instrument made payable to 

the employee’s organization. Any such payment to the 

organization received by the employee should be 

submitted with his or her travel voucher as soon as 

practicable. In-kind travel benefits that were furnished 

by an NFE to ensure that appropriate deductions are 

made in the travel, per diem, and other allowances 

payable by the United States should be excluded in the 

travel voucher. 

Travel-approving authorities designated to accept 

travel benefits from NFEs shall submit a report to the 

DoD component designated agency ethics official 

(DAEO), the alternate DAEO, or designee semiannually (on April 30 and October 31) to accommodate 

the required reporting to the Office of Government 

Ethics (on May 31 and November 30 of each year). 

Within the US Army Medical Command, reports are 

consolidated and forwarded by the MEDCOM Office 

of the Staff Judge Advocate. 

ACCEPTANCE OF TRAVEL BENEFITS INCIDENTAL TO

TRAINING OR IN CONJUNCTION WITH PRESENTATION

OF AN AWARD

In accordance with 5 USC §4111 and JER, paragraph 

4-102,1(p47) military employees can accept contributions, awards, travel benefits, and other payments 

from NFEs incident to training in nongovernment 

facilities. Benefits can be accepted directly from NFEs 

only when all of the following conditions are met: 

1.  The source is a tax-exempt organization 

described by 26 USC §501(c)(3) or a state or 

local government (see 5 CFR 410, Subpart G).

2.  The contribution, award, or payment of travel 

benefits is incidental to training in nonfederal 

government facilities or attendance at a meeting.

3.  An appropriate deduction is made from any payment by the federal government to the employee 

for his or her official travel entitlement.

4.  The contribution, award, or payment is not a 

reward for services to the NFE.

5.  Acceptance of the contribution, award, or 

payment would not reflect unfavorably on the 

employee’s ability to perform his or her duties in 

a fair and objective manner, nor would it 

otherwise compromise the integrity of any 

federal government action.

6.  The travel approving authority authorizes the 

acceptance of the contribution, award, or 

payment in writing.
64 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

In accordance with 5 CFR 2635.204(d), cash prizes 

may be accepted by military employees if they are part 

of a bona fide award, or incident to a bona fide award, 

that is given for meritorious public service or 

achievement by an individual or organization that does 

not have interests which may be substantially affected 

by the performance or nonperformance of the 

employee’s official duties. Examples of such an award 

include the Nobel Prize for Medicine and the Russell 

and Burch Award presented by the Humane Society of 

the United States. 

Employees who receive an award or prize may also 

accept travel benefits, meals, and entertainment given 

to them and to members of their families at the event 

at which the presentation of the award takes place. If 

the value of these benefits, combined with the value of 

the prize, is more than $200, a written determination is 

required from an ethics counselor that the award is part 

of an established plan of recognition made on a regular 

basis pursuant to written standards. 

Finally, when more than one organization participates 

in making a single contribution, award, or travel 

payment, only the organization that actually selects the 

recipient and administers the funds from which the 

contribution, award, or travel payment will be made 

will be considered as the source of the travel benefits. 

Individuals who are required to file financial 

disclosure statements must report acceptance of such 

travel benefits on their financial disclosure statements 

if the fair market value of those benefits meet or 

exceed the reportable amount. 

PROCEDURES AND RESPONSIBILITIES OF THE TRAVELAPPROVING AUTHORITY, THE TRAVELER, AND THE

ETHICS COUNSELOR

Generally, the travel-approving authority shall: 

 Approve or disapprove acceptance of travel 

benefits in-kind or payments of travel expenses 

from nonfederal sources. 

 Acquire the concurrence of the ethics counselor 

when approving travel benefits in accordance with 

the conflict of interest analysis required by 41 

CFR 304-1.5. 

 Prepare and submit a report to the DoD component 

designated agency ethics official or designee 

(normally the servicing ethics counselor), 

reporting all travel benefits over $335 accepted in 

accordance with the authority granted under 31 

USC §1353. 

 Prepare and submit a report to the DoD component 

DAEO or designee (normally the servicing ethics 

counselor), within 30 days after completion of 

travel for which travel benefits have been paid by 

nonfederal sources under 5 USC §4111. 

Generally, ethics counselors will: 

 Prepare and submit semiannual reports of 

payments under 31 USC §1353 (due May 31 and 

November 30 of each year). 

 Retain reports from the travel-approving authority 

under 5 USC §4111 for 2 years. 

 Provide written concurrence or nonconcurrence for 

the approval of travel benefits, in accordance with 

the conflict of interest analysis required by 41 

CFR 304-1.5. 

Generally, each military employee shall prepare and 

submit a report (sample report provided on page 67) to 

the travel-approving authority reporting all travel 

benefits received that totaled $335 or more, in 

accordance with the provisions of 31 USC §1353. The 

report should provide the following information, be 

signed by both the traveler and the travel-approving 

authority, and forwarded to the servicing legal office: 

1.  Name of the reporting organization.

2.  List of each event, (meeting, or similar function) 

for which the organization accepts payment of 

more than $335 (for a member and spouse 

together, or for either the member or the spouse 

separately), including sponsor of the event, 

location of the event, date(s) of the event, and 

nature of the event.

3.  Name of each member for whom such payment 

was accepted in connection with the event, 

including the member’s government position 

and member’s travel date(s) in connection with 

attendance at the event.

4.  Name of the accompanying spouse, if 

applicable, for whom payment was accepted in 

connection with the event, including the name of 

the member accompanied by the spouse, 

member’s government position, and spouse’s 

travel date(s) in connection with attendance at 

the event.

Gifts of Travel Benefits from Nonfederal Sources to Military and Civilian Government Employees 
 January – March 2010 65

THE ARMY MEDICAL DEPARTMENT JOURNAL

5.  Identity of any nonfederal source from which 

payment was accepted in connection with the 

event.

6.  Itemization of the benefits accepted by the 

organization in connection with attendance at the 

event, including a description of the benefit, 

provided that benefits accepted as a part of a 

conference or training fee need not be reported 

separately; method of payment (payment inkind, or by check or similar instrument); 

individual for whom payment was accepted 

(member or spouse); the name of the nonfederal 

source that provided the benefit(s); and the 

amount of payment.

7.  Total value of the payments accepted for the 

member and/or spouse in connection with the 

event, indicating the total amount of payments 

provided by check or similar instrument and the 

total value of payments provided in-kind.

8.  Provide all necessary information to the travelapproving authority for a semiannual report to 

the DoD Component DAEO.

9.  Turn in any merchandise or other benefits as 

required under the JER.

REFERENCES

1. Department of Defense 5500.7-R: Joint Ethics 

Regulation. Washington, DC: US Dept of Defense; 

March 3, 2006. Available at: http://www.dod.mil/

dodgc/defense_ethics/ethics_regulation/jer1-6.doc. 

Accessed January 14, 2010. 

2. Department of Defense Directive 1005.13: Gifts and 

Decorations from Foreign Governments. 

Washington, DC: US Dept of Defense; December 6, 

2002. Available at: http://www.dtic.mil/whs/direc 

tives/corres/html/100513.htm. Accessed January 14, 

2010. 

3. 41 CFR 304-5.3. 

AUTHOR

MAJ Topinka is Deputy Staff Judge Advocate, US 

Army Medical Command, Fort Sam Houston, Texas. 
66 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

Gifts of Travel Benefits from Nonfederal Sources to Military and Civilian Government Employees 

Sample of memorandum form to document record of the nonfederal entity offer to provide travel benefits to 

Department of the Army personnel, and concurrence or nonconcurrence by the ethics counselor. 

MEMORANDUM FOR THE RECORD

SUBJECT: Approval of Acceptance of Travel Benefits Pursuant to 31 USC §1353 

1. Travel benefits have been offered by ___[name of nonfederal entity]___ to ___[name of Army personnel 

who will receive the travel benefit]___ to permit him/her to ___[insert the reason the person will be 

traveling]___. This event will occur on ___[insert dates]___. The Army employee will ___[explain 

further what the army employee will be doing, if necessary. Attach program brochure or the offer letter 

from the nonfederal entity, if available.]___. 

2. The following travel and related expenses have been offered to be provided in-kind to the Department of 

the Army: 

Round-trip air fare [approximate value] 

Rental car [estimated cost] 

Lodging [approximate hotel rate] 

Meals [identify the meals to be provided] 

Registration fee [full value] 

3. I have reviewed the offer of travel benefits, taking into account such factors as the source of the gift, the 

amount of the gift, to whom it is offered, whether there are any matters pending before the Army 

concerning the nonfederal entity offering the travel benefits and whether the proposed recipient of the 

travel benefits makes any decisions pertaining to the nonfederal entity. 

4. I hereby determine that the acceptance of these travel benefits would / would not [select one] cause a reasonable person with knowledge of all the relevant facts to question the integrity of the Army’s programs or 

operations and approve / disapprove [select one] acceptance of the above-described travel benefits. 

5. This approval has been coordinated with the Ethics Counselor and written approval has been obtained as 

evidenced by the concurrence block below OR the attached written opinion [select one]. If the travel 

benefits received exceed $335, the traveler will file a report of travel benefits accepted to their Ethics 

Counselor within 15 days of completion of the travel. 

6. A copy of this memorandum and attachments shall be retained by the recipient of the travel benefits and 

his/her ethics counselor. 

Signature Block and title of travel approval authority 

Ethics Counselor Coordination 

Concur _________________ Nonconcur ______________ 

Date: ____________________ 
 January – March 2010 67

THE ARMY MEDICAL DEPARTMENT JOURNAL

REPORT OF SPONSOR PAYMENT OF TRAVEL AND RELATED EXPENSES

ACCEPTED FROM NONFEDERAL SOURCES

(31 USC, §1353) 

Employee’s Name: _____________________________ 

Command/Organization: ____________________________ 

Employee’s Position: ________________________________ 

Spouse’s Name (if applicable): _____________________________ 

Event (for which more than $335 in travel and related expenses were donated) 

Nature/Title of Event: __________________________________________ 

Sponsor: ____________________________________________________ 

Location: ____________________________________________________ 

Dates: From ____________ To: ____________ 

Type Of Donation 

Donating Organization: _________________________________________ 

Total Amount: ________________________________________________ 

Amount of Payments-in-Kind: For Employee: _____ For Spouse _____ 

(Prepaid: conference fees, hotel costs, airline tickets, meals, etc.) 

Amount of Payment by Check: For Employee: _____ For Spouse _____ 

(Check must be made to “Department of the Army” and submitted to your travel office) 

Itemized Expenses 

Hotel: _____ 

 Airline: _____ 

 Meals: _____ 

 Other: _____ 

Your Certification 

“I certify that the statement on this report are true, complete, and correct to the best of my knowledge.” 

_______________________________________ 

Signature Date 

Submit Report To Your Ethics Counselor Below Within 15 Days Of Travel 

Sample of report to the travel-approving authority reporting all travel benefits received that totaled $335 or 

more, in accordance with the provisions of 31 USC §1353. 
68 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

INTRODUCTION

Department of Defense (DoD) policy limits the outside 

employment activities of DoD healthcare providers. 

This article provides an overview of US Army Medical 

Command (MEDCOM) regulations and policies 

affecting off-duty employment (ODE) as well as Army 

regulations relevant to special categories of off-duty 

work. It also highlights where joint ethics regulation 

standards intersect with ODE issues. 

GENERAL RULES

The promulgating authority is the Assistant Secretary 

for Health Affairs. DoD Health Affairs Policy 96-050 1

sets forth the DoD-wide rules governing off-duty 

employment by healthcare providers. The DoD policy 

is implemented within the Army Medical Command 

by MEDCOM Regulation 600-3.

2

 Subordinate 

commands have further implemented procedures for 

filing and processing ODE applications. 

The ODE rules ensure all military and civilian 

healthcare providers’ “time, talents, and attention” are 

devoted first and foremost to their military healthcare 

duties as provided in paragraph 6b of MEDCOM 

Regulation 600-3.

2(pp2-3) The DoD and MEDCOM 

policies tolerate no interference from voluntary outside 

employment obligations on the mission of providing 

round-the-clock health care to the Soldier and other 

beneficiaries. 

All ODE must be approved by the healthcare 

provider’s commander in writing before the healthcare 

provider is authorized to begin the work. Timely 

processing of requests will help to ensure providers do 

not circumvent the approval process because of missed 

outside professional opportunities. In practice, 

personnel do knowingly fail to seek approval for 

covered activities; paragraph 6a of MEDCOM 

Regulation 600-3.

2(p2) states that noncompliance with 

the process is grounds for punishment under the 

Uniform Code of Military Justice,* as well as grounds 

for other authorized administrative actions. The 

clinical quality management program and 

credentialing processes described in Army Regulation 

40-68 4

 are examples of such otherwise authorized 

administrative actions. 

The purpose paragraph of MEDCOM Regulation 

600-3 2(p1) uses the term “off-duty commitments” and 

defines it as encompassing professional work and 

nonprofessional (nonmedical) work, including selfemployment, and healthcare work done on a volunteer 

basis. In this paper, “ODE” should be understood to 

encompass all of these activities. 

Healthcare providers subject to MEDCOM Regulation 

600-3 include all persons delivering direct patient care 

as designated by the Assistant Secretary of Defense. 

The list of professions includes: physicians, dentists, 

registered nurses, practical nurses, physical therapists, 

podiatrists, optometrists, clinical dieticians, social 

workers, clinical pharmacists, clinical psychologists, 

occupational therapists, audiologists, speech 

pathologists, and physician assistants.2(pp1-2)

LIMITATIONS ON OFF-DUTY EMPLOYMENT

Hours. Because military duties cannot be impaired by 

ODE, the regulation restricts work hours and travel 

time between the duty location and the ODE location. 

The regulation mandates the provider allow a 6-hour 

rest period following ODE before resuming regular 

duties (a rest period before ODE is not required by 

regulation, but providers should exercise appropriate 

professional judgment about whether rest is needed). 

The regulation directs commands to develop local 

Off-Duty Employment of Department of 

Defense Health Care Providers 

CPT Holly Bryant, JAG, USA 

*The Uniform Code of Military Justice (UCMJ), a federal law,3

is the judicial code which pertains to members of the United 

States military. Under the UCMJ, military personnel can be 

charged, tried, and convicted of a range of crimes, including 

both common-law crimes (eg, arson) and military-specific 

crimes (eg, desertion). 
 January – March 2010 69

procedures to implement the program; some localities 

require that the government supervisor endorse the 

provider’s application and comment on the impact of 

ODE on care in the clinical setting (based on 

appointment demand, waiting times, and current 

staffing). This is a helpful addition to the application 

packet in a medical treatment facility (MTF) or 

community hospital, but may not be applicable to all 

practice settings. 

Trainees. Officer trainees in graduate training programs 

are prohibited from engaging in off-duty employment. 

At MTFs, this will include interns and residents. 

Status. Off duty employment cannot be performed in a 

permissive temporary duty status, or while on pass or 

compensatory time for overtime previously worked; 

regular leave may be used if this does not adversely 

impact the military mission. The ODE cannot incur 

any expense to the government, including use of 

military equipment or supplies. 

Reports. A monthly report is required from each person 

performing ODE; the report of hours worked must be 

signed by the civilian employer. The commander of 

each provider engaged in ODE must submit an annual 

report to MEDCOM summarizing the ODE hours 

worked by each of those providers. 

PROCEDURES

Samples of 2 types of applications are provided in the 

appendices of MEDCOM Regulation 600-3,

2(pp8-14) one 

for professional ODE (Appendix A) and one for 

nonprofessional ODE (Appendix B). There is also a 

sample letter of acknowledgement for the proposed 

ODE employer to sign (Appendix E). The letter of 

acknowledgement, which should be provided in the 

ODE application packet, memorializes the employer’s 

understanding that: 

 The provider cannot accept responsibility for 

ongoing care of patients. 

 The provider must respond to the government 

employer’s alerts and must accordingly leave the 

ODE worksite if called. 

 The employer cannot bill TRICARE,* medicare, 

medicaid, or collect payment from patients directly 

when the patients are DoD beneficiaries receiving 

care from a DoD healthcare provider. 

 The ODE will not involve expense to the 

government. 

 The hours will be limited to 16 per week unless an 

exception has been granted in advance. 

 The employer will sign monthly reports of hours 

worked. 

 The employer will provide information to the 

commander about the ODE upon request. 

An exception to the policy forbidding ODE employers 

from billing DoD beneficiaries exists for dental care 

given to dependents, Retirees, and Retiree family 

members. Because these persons are not entitled to 

free dental care at the Dental Activity, there is no 

conflict for DoD providers to charge fees for care in 

their off-duty capacity.5

All personnel are responsible for obtaining the 

appropriate licenses and insurance to practice in the 

private sector. Off-duty employment is not covered 

under the federal Tort Claims Act6

 or the Gonzales 

Act.7

 Personnel who will prescribe drugs must abide 

by the federal Controlled Substances Act8

 and Drug 

Enforcement Agency rules, and they must register and 

pay taxes, as do all nonfederal providers. 

EACH OFF-DUTY EMPLOYMENT ARRANGEMENT MUST

BE APPROVED SEPARATELY

The requirement to obtain advance written approval 

applies whether or not any of the covered activities are 

undertaken on a voluntary basis or on leave, including 

transition leave. ODE offers a seamless transition to 

post government employment and is a popular means 

of transitioning; the conflict of interest analysis 

required by the ODE regulation should mirror the 

analysis and counseling ethics counselors give all 

personnel transitioning out of government service. The 

same conflict of interest concerns, including potential 

for the appearance of conflicts, arise in ODE as in post 

government employment. 

TYPES OF OFF-DUTY EMPLOYMENT; PRIVATE MEDICAL

PRACTICE; LOCUM TENENS

MEDCOM Regulation 600-3 2 specifically forbids 

covered personnel from engaging in solo medical 

practice or assuming continuing care for a patient or 

*TRICARE is DoD’s health care program for members of the 

uniformed services, their families, and their survivors. 

Information available at http://www.tricare.mil.
70 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

patients, due to the potential for conflict with official 

duties. Covered personnel should be working ODE in 

a team setting in which other practitioners can provide 

follow-up care to patients. Some medical specialty 

areas lend themselves better to a variety of practice 

arrangements that are closer to the line. For example, it 

may be feasible for a healthcare provider to enter ODE 

practice with a partner during transition leave for the 

purpose of providing surgical or anesthesia care, or 

performing radiology or pathology work, because the 

partner and the patients’ primary care doctors provide 

the necessary follow-up care. Specialty areas with high 

patient contact like internal medicine, oncology or 

family practice probably require an ODE setting with 

more providers to ensure follow-up care is covered. 

Providers should make clear in their application how 

their proposed ODE meets the requirements if it 

appears problematic. 

WRITING, TEACHING, SPEAKING, AND LECTURING

Although the MTF commander is the approval 

authority for these ODE activities, practitioners must 

be mindful of the potential public affairs (PA), 

operational security (OPSEC), and intellectual 

property (IP) implications of their public speaking and 

writing activities. 

Speaking and writing will not be considered ODE if 

they are uncompensated, related directly to official 

duties, and performed on official time, whether on 

offsite temporary duty status or not. The PA, OPSEC, 

and IP concerns do continue to pertain to official 

publication, teaching, and speaking. 

Prior to publicly releasing any official medical 

information in any form, providers must obtain review 

from the PA officer, designated OPSEC officer, and 

the commander’s designated medical reviewer. 

SERVING AS A MEDICAL CONSULTANT FOR

REMUNERATION

Practitioners who are board-certified in a specialty or 

who are designated consultants to The Surgeon 

General may consult with civilian practitioners for 

remuneration if they have advance written approval 

from the Commander and the patient in question is not 

a DoD healthcare beneficiary. If the patient is a 

beneficiary, the consultation can be done, but without 

the remuneration. 

EXPERT TESTIMONY

Paragraph 7-10 of Army Regulation 27-40 prohibits 

giving testimony as a medical expert witness in private 

litigation.9 MEDCOM Regulation 600-3 further 

defines medical expert witness work to include work 

as a medico-legal consultant for a law firm, whether or 

not in-court testimony is to be involved.2(p6)

Commanders are not authorized to approve such work 

or testimony. Rather, paragraph 7-10b of Army 

Regulation 27-40 states: 

...the Litigation Division may grant special written 

authorization for present or former DA [Department of 

the Army] personnel to testify as expert or opinion 

witnesses at no expense to the United States.9

If an ODE question arises regarding expert or opinion 

testimony, legal advisors should advise their 

commanders of this limit to their authority and 

facilitate coordination with the Office of the Judge 

Advocate General, Litigation Division. 

PROVIDING VOLUNTEER HEALTHCARE SERVICES

Healthcare providers may participate in their personal 

capacity in medical and humanitarian missions with 

private groups of all kinds, including those providing 

care to institutionalized persons. Legal representatives 

of the MTF must review these ODE proposals for 

conflicts of interest. MEDCOM Regulation 600-3

requires the benefiting institution to obtain a letter 

from the provider’s commander stating that 

the individual is performing charitable work as a private 

citizen and that the Government assumes no responsibility for the individual’s actions.2(p6)

OUTSIDE EMPLOYMENT OF A NONPROFESSIONAL

NATURE, INCLUDING SELF-EMPLOYMENT

This category includes sales work of all kinds, 

including the following list given in the purpose 

paragraph of MEDCOM Regulation 600-3: 

...insurance, stocks, mutual funds, cosmetics, household supplies, vitamins, and other consumer goods and 

services, whether commercially manufactured or 

handcrafted.2(p1)

Again, these must be approved in advance; 

additionally, the rules prohibiting the use of 

government resources for personal business enterprises 

and solicitation in the federal workplace apply to these 

activities. 

Off-Duty Employment of Department of Defense Health Care Providers 
 January – March 2010 71

THE ARMY MEDICAL DEPARTMENT JOURNAL

CONCLUSION

The rules governing ODE are designed to make a 

blanket prohibition on ODE unnecessary. They are 

technical, and providers often resent both the rules and 

the process of getting an application approved. An 

effective local policy and institutional effort to 

minimize the time to process these applications can 

make the rules painless to live with, ensure the 

transparency of providers’ extracurricular activities, 

protect providers from unintended consequences, and 

ensure the military healthcare mission is fully 

supported by its human resources. 

REFERENCES

1. Department of Defense Health Affairs Policy 96-050: 

Policy for Off-Duty Employment by DoD Health Care 

Practitioners. Washington, DC: US Dept of Defense; 

July 23, 1996. 

2. US Army Medical Command Regulation 600-3: OffDuty Employment. Fort Sam Houston, TX: US Army 

Medical Command; March 21, 2008. 

3. 64 Stat. 109, 10 USC, chap 47. 

4. Army Regulation 40-68: Clinical Quality 

Management. Washington, DC: US Dept of the 

Army; February 26, 2004. 

5. Department of Defense Health Affairs Policy 97-019: 

Off-Duty Employment by DoD Dental Providers. 

Washington, DC: US Dept of Defense; July 23, 1996. 

6. 28 USC §§2671-2680. 

7. 10 USC §1089. 

8. 21 USC §801 et seq. 

9. Army Regulation 27-40: Litigation. Washington, DC: 

US Dept of the Army: September 19, 1994:16. 

AUTHOR

CPT Bryant is a Recruiting Officer, Judge Advocate 

Recruiting Office, Rosslyn, Virginia. 
72 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

BACKGROUND

Attorneys frequently want Department of the Army 

healthcare providers (HCPs) to serve as witnesses in 

litigation, which is defined as 

...all pretrial, trial, and post trial stages of all existing or 

reasonably anticipated judicial or administrative 

actions, hearings, investigations, or similar proceedings 

before civilian courts, commissions, boards...or other 

tribunals, foreign and domestic.1(p37)

This broad definition also includes

...responses to discovery requests, depositions, and 

other pretrial proceedings, as well as responses to 

formal or informal requests by attorneys or others in 

situations involving litigation.1(p37)

TYPES OF LITIGATION

Litigation in Which the United States Has an Interest 

This category encompasses cases in which the United 

States is either named as a party or has an official interest 

in the outcome of the litigation. Examples include 

medical malpractice complaints brought under the 

Federal Tort Claims Act2

 and suits by the government 

pursuant to the Medical Care Recovery Act.3

Private Litigation 

Private litigation is that litigation in which the 

government is not a party and has no official interest in 

the outcome. Examples include personal injury cases in 

which the Army provided medical care, non-Department 

of Defense civilian medical malpractice cases, divorce 

proceedings, child abuse hearings, and competency 

hearings of retirees or dependents.

TYPES OF REQUESTED TESTIMONY

There are 2 types of requested testimony: expert 

testimony, when a litigant seeks a professional opinion, 

hypothetical responses, and/or prognosis from the HCP; 

and factual testimony, when a litigant seeks facts from an 

Army HCP concerning medical care such as treatment or 

observations provided to one of the parties.

APPEARANCE AS A WITNESS

Generally, Department of the Army personnel may not 

appear as witnesses in any litigation absent proper 

authorization. Such authorization will usually be granted 

if certain conditions are met.

Litigation in Which the United States Has an Interest 

When the United States is a party or has an interest in the 

litigation, there is only one restriction on the testimony of 

Army HCPs: they may not provide opinion or expert 

testimony for a party whose interests are adverse to those 

of the United States. All requests for Army HCPs to 

serve as expert or opinion witnesses for the United States 

are referred to the Litigation Division, Office of the 

Judge Advocate General (Litigation Division), unless the 

request involves a matter that has been delegated to a 

Staff Judge Advocate (SJA) or legal advisor. All requests 

for interviews or subpoenas for the testimony of Army 

HCPs are referred to the SJA or legal advisor serving the 

provider’s medical treatment facility.

Travel arrangements for witnesses for the United States 

are normally made by the Department of Justice through 

the Litigation Division, which issues instructions for the 

witness travel, including a fund citation, to the 

appropriate commander. An SJA or legal advisor may 

make arrangements for the local travel of Army HCPs 

requested by US Attorneys, or by attorneys representing 

the government’s interests in actions brought under the 

Medical Care Recovery Act,3

 provided that the HCP is 

stationed at an installation in the same judicial district or 

not more than 100 miles from the place where testifying.

Private Litigation 

Expert or Opinion Testimony. Army HCPs may not 

provide expert or opinion testimony in private litigation. 

That restriction applies even if the HCP is to testify 

without compensation. Additionally, although certain 

exceptions apply to other Department of the Army 

personnel, those exceptions apparently do not apply to 

HCPs. The Chief of the Litigation Division should be 

contacted on a case-by-case basis. If a court or other 

appropriate authority orders an Army HCP to provide 

expert or opinion testimony, the witness must 

Witnesses: The Rules for Army Health Care 

Providers 

CPT Ean P. White, JAG, USA 
 January – March 2010 73

immediately notify the Litigation Division. The 

Litigation Division will determine whether to challenge 

the subpoena or court order and will direct the witness to 

either testify or to respectfully decline to comply.4

Factual Testimony. Army HCPs may provide factual 

testimony in private litigation concerning patients they 

have treated, investigations they have made, laboratory 

tests they have conducted, or other actions they have 

taken in the regular course of their duties. Such testimony 

must be approved by the SJA or medical treatment 

facility (MTF) legal advisor and the HCP’s supervisor. In 

such cases, the HCP’s testimony must be limited to 

factual matters and it may not extend to hypothetical 

questions or to a prognosis.

Legal Representative. Frequently at depositions or at trial, 

counsel ask treating physicians to give expert or opinion 

testimony despite the regulatory prohibitions against such 

testimony. Consequently, a Judge Advocate or Army 

civilian attorney “should be present during any interview 

or testimony to act as legal representative of the Army.”1

(p16) If a question in an interview or deposition seeks 

expert or opinion testimony, the legal representative will 

advise the Army HCP not to answer the question. In the 

case of court testimony, the legal representative should 

advise the judge that Department of Defense directives 

and Army regulations prohibit the witness from 

answering the question without the approval of the 

Department of the Army.

OTHER MATTERS

Moonlighting 

If, because of off-duty employment, an Army HCP is 

required to participate in private litigation as either a 

defendant or as a treating physician, any testimony 

provided must be limited to factual matters. This 

limitation ensures that government imprimatur is not 

given to the HCP’s testimony. Under no circumstances 

are Army medical personnel allowed to “moonlight” as 

expert witnesses. This includes off-duty employment as a 

medical/legal consultant for a law firm or attorney, even 

if actual in-court testimony is neither required nor desired 

by the firm or attorney.

Medical Records 

Army HCPs who are subpoenaed to testify at a 

deposition or trial frequently receive a subpoena duces 

tecum to produce pertinent medical records. Army 

medical records are the property of the US government5

and the MTF commander is the official medical records 

custodian at his or her facility. The chief of the MTF’s 

Patient Administration Division (PAD) acts for the MTF 

commander in matters pertaining to medical records. 

Consequently, requests for medical records should be 

made to the PAD where the request will be processed in 

accordance with applicable rules and regulations. Stricter 

rules govern the release of alcohol abuse or drug abuse 

treatment records. 

Quality Assurance Information 

HCP may be asked to testify regarding quality assurance 

information in situations which do not qualify as an 

exception to the prohibition against disclosure of quality 

assurance information outlined in 10 USC §1102. For 

example, an HCP is asked to be a witness in a factfinding meeting in conjunction with an equal opportunity 

complaint lodged by another HCP. The equal opportunity 

complainant alleges the quality assurance process by the 

MTF was based upon racial discrimination and compels 

the HCP to testify regarding details of the process. The 

HCP is not permitted to testify or release quality 

assurance information in any form to the equal 

opportunity officer. Another example of an equal 

opportunity request for impermissible disclosure would 

be an allegation by the complainant that the quality 

assurance process was instituted by the MTF in 

retaliation for previous complaints against the MTF by 

the complainant. All requests for testimony or other 

disclosure of quality assurance information must be 

evaluated on a case-by-case basis by the MTF 

commander with the assistance of legal counsel, 

following notification to the US Army Medical 

Command Office of the Staff Judge Advocate.

REFERENCES

1. Army Regulation 27-40: Litigation. Washington, DC: 

US Dept of the Army; September 19, 1994. 

2. 28 USC §2671-2680 and 1346(b). 

3. 28 USC §2651. 

4. US ex rel Touhy v Ragen, 340 US 462 (1951). 

5. Army Regulation 40-66: Medical Record 

Administration and Healthcare Documentation. 

Washington, DC: US Dept of the Army; June 17, 

2008. 

AUTHOR

CPT White is Assistant Staff Judge Advocate, US 

Army Medical Command, Fort Sam Houston, Texas. 
74 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

The Judge Advocate General’s Corps of the United States Army 

The Judge Advocate General's Corps of the United States Army is composed of Army officers who are lawyers and who 

provide legal services to the Army at all levels of command. The Judge Advocate General's Legal Service includes judge 

advocates, warrant officers, paralegal noncommissioned officers and junior enlisted personnel, and civilian employees. 

The Judge Advocate General is a lieutenant general. All military officers are appointed by the US President subject to the 

advice and consent of the Senate, but the Judge Advocate General is one of the few positions in the Army explicitly 

provided for by law in Title 10 of the United States Code and which requires a distinct appointment. 

THE JUDGE ADVOCATE GENERAL

General George Washington founded the US Army JAG Corps on July 29, 1775, with the appointment of William Tudor 

as the Judge Advocate General. The Army Judge Advocate General's Corps is the oldest of the judge advocate 

communities in the US armed forces, as well as the oldest “law firm” in the United States. The Judge Advocate General 

serves a term of 4 years. LTG Dana K. Chipman, appointed in October 2009, is the 38th Judge Advocate General of the 

Army. 

MISSION

Judge advocates serve in the position of Staff Judge Advocate on the special and personal staff of general officers in 

command who are general court-martial convening authorities (the authority to convene a general court-martial). Staff 

Judge Advocates advise commanders on the full range of legal matters encountered in government legal practice and 

provide advice on courts-martial as required by the Uniform Code of Military Justice. Subordinate judge advocates 

prosecute courts-martial, and others, assigned to the independent US Army Trial Defense Service and US Army Trial 

Judiciary, serve as defense counsel and judges. The almost 2,000 full-time judge advocates and civilian attorneys who 

serve The Judge Advocate General's Corps comprise the largest group of attorneys who serve the US Army. Several 

hundred other attorneys practice under the Chief Counsel of the United States Army Corps of Engineers and the 

Command Counsel of the United States Army Materiel Command. 

Judge advocates are deployed throughout the United States and around the world, including Japan, South Korea, 

Germany, Kosovo, Iraq, Afghanistan, Kuwait, and Qatar. They provide legal assistance to soldiers, adjudicate claims 

against the Army, advise commands on targeting decisions and other aspects of operational law, and assist the command 

in administering military justice by preparing nonjudicial punishment actions, administrative separation actions, and 

trying criminal cases at court-martial. 

In addition to the active component judge advocates, there are approximately 5,000 attorneys who serve in the US Army 

Reserve and the Army National Guard. Several hundred Reserve and National Guard attorneys have left their civilian 

practices to serve in support of Operations Iraqi Freedom and Enduring Freedom. 

LEGAL CENTER AND SCHOOL

The Judge Advocate General's School began in World War II at the University of Michigan to train new judge advocates 

as the Judge Advocate General's Department rapidly expanded. It was disestablished for a short time after the war. It was 

then reestablished at Fort Myer in Arlington, Virginia, but, after a short stay, was relocated to the University of Virginia 

in Charlottesville in 1951. The Judge Advocate General's Legal Center and School adjoins, but is distinct from, the 

University of Virginia School of Law. The Commandant of the Judge Advocate General's School is authorized by 

Congress to award a Master of Laws degree. The school is the only federal institution to have American Bar Association 

accreditation as an America's law schools. Judge Advocates from all 5 armed forces of the United States and international 

students attend the annual Judge Advocate Officer Graduate Course in which the Master's degree is awarded. The Legal 

Center and School also trains the Army's new judge advocates, provides continuing legal education for judge advocates 

and lawyers from throughout the United States government, and trains the Army's paralegal noncommissioned officers 

and court reporters. The School trains those officers appointed military judges, irrespective of service. 

INSIGNIA

The branch insignia consists of a gold pen crossed above a gold sword, superimposed over a laurel wreath. The pen 

signifies the recording of testimony, the sword represents the military character of the JAG Corps, and the wreath 

indicates honor. The insignia was created in May 1890 in silver and changed to gold in 1899. 
 January – March 2010 75

THE UNITED STATES ARMY MEDICAL DEPARTMENT REGIMENT

The US Army Medical Department was formed on July 27, 1775, when the Continental Congress authorized a Medical 

Service for an army of 20,000 men. It created the Hospital Department and named Dr Benjamin Church of Boston as 

Director General and Chief Physician. On 14 April, 1818 the Congress passed an Act which reorganized the staff 

departments of the Army. The Act provided for a Medical Department to be headed by a Surgeon General. Dr Joseph 

Lovell, appointed Surgeon General of the United States Army in April 1818, was the first to hold this position in the new 

organization. The passage of this law marks the beginning of the modern Medical Department of the United States Army. 

Throughout its early history, the size and mission of the US Army Medical Department would wax and wane in response 

to military events around the world. There was, however, no formal regimental organization until World War I. Then, in 

the late 1950s, the brigade replaced the regiment as a tactical unit. In the reorganization that followed, some Army units 

lost their identity, their lineage, their history. This loss did not go unnoticed. The US Army Regimental System was 

created in 1981 to provide soldiers with continuous identification with a single regiment. Department of the Army 

Regulation 600-82, The US Army Regimental System, states the mission of the regiment is to enhance combat 

effectiveness through a framework that provides the opportunity for affiliation, develops loyalty and commitment, fosters 

a sense of belonging, improves unit esprit, and institutionalizes the war-fighting ethos. 

The US Army Medical Department Regiment was activated on July 28, 1986, during ceremonies at Fort Sam Houston in 

San Antonio, Texas, the “Home of Army Medicine.” Lieutenant General Quinn H. Becker, the US Army Surgeon 

General and AMEDD Regimental Commander, was the reviewing officer. He was joined by general officers of the US 

Army Reserves and the Army National Guard, representing the significant contributions and manpower of the reserve 

forces in the Total Army concept. 

INSIGNIA

The AMEDD Regimental Distinctive Insignia was designed by the Institute of Heraldry and is one of the oldest crests in 

the Army today. The 20 stars on the crest correspond to the number of states in the Union between December 10, 1817, 

and December 3, 1818. The origin of the crest dates from the Act of April 14, 1818, by which the Medical Department of 

the Army was first organized. 

The alternating red and white stripes on the left side of the shield are the 13 stripes of the American Flag. The green staff 

is the staff of Asclepius (according to Greek mythology, the first healer, the son of Apollo, the sun god); and green was a 

color associated with the Medical Corps during the last half of the 19th century. The phrase “To Conserve Fighting 

Strength” gives testimony to our mission as combat multipliers and guardians of our Nation's strength and peace. 

INFORMATION

The Regimental web site (http://ameddregiment.amedd.army.mil/default.asp) is designed to provide you with useful 

information about the US Army Medical Department (AMEDD) Regiment. Through the web site, you can learn the 

history of the AMEDD Regiment, the symbolism behind our heraldic items, how to wear the Regimental Distinctive 

insignia, and various programs available to you and your unit. 

The Office of the AMEDD Regiment is located in Aabel Hall, Building 2840, on Fort Sam Houston, Texas. The 

Regimental staff can provide further information pertaining to the history of the Army Medical Department and the 

AMEDD Regiment, and assist with any of the services described in the web page. 

For additional information please contact the Army Medical Department Regimental Office at the following address: 

Commander 

US Army Medical Department Regiment 

ATTN: MCCS-GAR 

2250 Stanley Road 

Fort Sam Houston, Texas 78234-6100 

The telephone number is (210) 221-8455 or DSN 471-8455, fax 8697. 

Internet: http://ameddregiment.amedd.army.mil/ 

Email: amedd.regiment@amedd.army.mil 
76 http://www.cs.amedd.army.mil/dasqaDocuments.aspx?type=1

The US Army Medical Department Center and School, Fort Sam Houston, Texas 

THE ARMY MEDICAL DEPARTMENT JOURNAL
SUBMISSION OF MANUSCRIPTS TO THE ARMY MEDICAL DEPARTMENT JOURNAL

The United States Army Medical Department Journal is published quarterly to expand knowledge of domestic and international 

military medical issues and technological advances; promote collaborative partnerships among the Services, components, Corps, 

and specialties; convey clinical and health service support information; and provide a professional, high quality, peer reviewed 

print medium to encourage dialogue concerning health care issues and initiatives. 

REVIEW POLICY

All manuscripts will be reviewed by the AMEDD Journal’s Editorial Review Board and, if required, forwarded to the appropriate 

subject matter expert for further review and assessment. 

IDENTIFICATION OF POTENTIAL CONFLICTS OF INTEREST

1. Related to individual authors’ commitments: Each author is responsible for the full disclosure of all financial and personal 

relationships that might bias the work or information presented in the manuscript. To prevent ambiguity, authors must state 

explicitly whether potential conflicts do or do not exist. Authors should do so in the manuscript on a conflict-of-interest 

notification section on the title page, providing additional detail, if necessary, in a cover letter that accompanies the 

manuscript. 

2. Assistance: Authors should identify Individuals who provide writing or other assistance and disclose the funding source for this 

assistance, if any. 

3. Investigators: Potential conflicts must be disclosed to study participants. Authors must clearly state whether they have done 

so in the manuscript. 

4. Related to project support: Authors should describe the role of the study sponsor, if any, in study design; collection, analysis, 

and interpretation of data; writing the report; and the decision to submit the report for publication. If the supporting source

had no such involvement, the authors should so state. 

PROTECTION OF HUMAN SUBJECTS AND ANIMALS IN RESEARCH

When reporting experiments on human subjects, authors must indicate whether the procedures followed were in accordance with 

the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki 

Declaration of 1975, as revised in 2000. If doubt exists whether the research was conducted in accordance with the Helsinki 

Declaration, the authors must explain the rationale for their approach and demonstrate that the institutional review body 

explicitly approved the doubtful aspects of the study. When reporting experiments on animals, authors should indicate whether the 

institutional and national guide for the care and use of laboratory animals was followed. 

GUIDELINES FOR MANUSCRIPT SUBMISSIONS

1. Articles should be submitted in digital format, preferably an MS Word document, either as an email attachment (with 

illustrations, etc), or by mail on CD or floppy disk accompanied by one printed copy of the manuscript. Ideally, a manuscript 

should be no longer than 24 double-spaced pages. However, exceptions will always be considered on a case-by-case basis. In 

general, 4 double-spaced MS Word pages produce a single page of 2 column text in the AMEDD Journal production format. 

2. The American Medical Association Manual of Style governs formatting in the preparation of text and references. All articles 

should conform to those guidelines as closely as possible. Abbreviations/acronyms should be limited as much as possible. 

Inclusion of a list of article acronyms and abbreviations can be very helpful in the review process and is strongly encouraged.

3. A complete list of references cited in the article must be provided with the manuscript. The following is a synopsis of the 

American Medical Association reference format: 

 Reference citations of published articles must include the authors’ surnames and initials, article title, publication title, 

year of publication, volume, and page numbers. 

 Reference citations of books must include the authors’ surnames and initials, book title, volume and/or edition if 

appropriate, place of publication, publisher, year of copyright, and specific page numbers if cited. 

 Reference citations for presentations, unpublished papers, conferences, symposia, etc, must include as much identifying 

information as possible (location, dates, presenters, sponsors, titles). 

4. Either color or black and white photographs may be submitted with the manuscript. Color produces the best print reproduction

quality, but please avoid excessive use of multiple colors and shading. Digital graphic formats (JPG, GIF, BMP) and MS Word 

photo files are preferred. Prints of photographs are acceptable. Please do not send photos embedded in PowerPoint. Images 

submitted on slides, negatives, or copies of X-ray film will not be published. For clarity, please mark the top of each 

photographic print on the back. Tape captions to the back of photos or submit them on a separate sheet. Ensure captions and 

photos are indexed to each other. Clearly indicate the desired position of each photo within the manuscript. 

5. The authors’ names, ranks or academic/certification credentials, titles or positions, current unit of assignment, and contact 

information must be included on the title page of the manuscript. 

6. Submit manuscripts to: 

EDITOR, AMEDD JOURNAL

ATTN MCCS HT 

2419 HOOD ST STE C 

FORT SAM HOUSTON, TX 78234-7584 

DSN 471-6301 

Comm 210-221-6301 

Email: amedd.journal@amedd.army.mil