What’s New in
Military Health Law?
FOR THE MILITARY HEALTH LAW SYMPOSIUM
John A. Casciotti
DoD Office of General Counsel
September 2015
Military Health Law: Who’s Who?
Mr. Robert Taylor
Acting General Counsel of DoD
Hon. Jonathan Woodson, M.D.
ASD for Health Affairs
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Outline
• Military Health Law Network Refresher
• Whazup?
• Big Issues in 2015 & 2016
– Budget & Sequestration
– Discrimination in Health Care Programs
– Quality Assurance & Patient Safety
• Whadayado?
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Military Health Law Network
Research Helper
http://www.usuhs.mil/ogc/mhln
Appropriations
• H.R. 2685 (H.Rept. 114-139); S. 1558 (S.Rept. 114-63):
DoD Appropriations Act 2016
Disability Evaluation System
• DoD 1332.18-M, Disability Evaluation System, 2014 (3
volumes)
• http://warriorcare.dodlive.mil/disability-evaluation/ides/
Education
• DoDM 1342.12, Implementation of Early Intervention
and Special Education Services to Eligible DoD
Dependents, 6/17/15
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DoD Budget Proposals FY 16
• Consolidated TRICARE Health Plan
– Replacing triple option
– Copays higher than Prime, but less than Standard
– Freedom of choice of provider
– Save $3.9B FY16-20
• “TRICARE for Life” Enrollment Fee
• Pharmacy Copay Increases
– From current $8/20/XX & $0/16/46 phase to 2025:
$14/46/XX and $14/46/92
– Senate bill includes
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Military Compensation &
Retirement Modernization Com.
• Establish 4-star Joint Readiness Command,
identify Essential Medical Capabilities,
increase MTF readiness-related workload
• Replace current TRICARE with OPMadministered FEHBP-like plans
• Reform ECHO to align with State Medicaid
plans
• Increase DoD-VA collaboration on medical
records, pharmacy formularies, etc.
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More Potential Budget Issues
• Rx refills for chronic
conditions out of retail
– TFL now; Other retirees
10/1/15
• “OCO Gimmick” veto?
• Back to sequestration?
• Full year CR?
• Approps Bills FY16
shortfall $.7 to $1.4B
• Mil-to-Civ personnel
conversions?
• Modernization study
resizing of some MTFs?
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Ebola: Operation United
Assistance
• P&R Memo 10/31/14: 21 days controlled
monitoring of milpers returning to US with no
known exposure; voluntary for civpers
• CDC: active monitoring or direct active
monitoring; no asymptomatic quarantine
• 4 MTFs designated as potential treatment
sites as backup to CDC-designated centers
• DSD Memo 8/10/15: Termination of OUA,
Maintaining Certain Guidance & Authorities
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Ebola (continued)
• Mayhew v. Kaci Hickox, State Dist. Ct. Maine (10/31/14)
• Active monitoring, no quarantine for asymptomatic nurse
• “[T]he court is fully aware of the misconceptions,
misinformation, bad science and bad information being
spread from shore to shore in our country with respect to
Ebola. The Court is fully aware that people are acting
out of fear and that this fear is not entirely rational.
However, whether that fear is rational or not, it is present
and it is real. Respondent’s actions at this point, as a
health care professional, need to demonstrate her full
understanding of human nature and the real fear that
exists.”
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Medical Ethics: Defense Health
Board Report (March 2015)
• 16 Recommendations, including:
2. DoD must ensure that the military health care
professional’s first ethical obligation is to the patient
3. DoD . . . should excuse health care professionals
from performing medical procedures that violate their
professional code of ethics (except re care for military
members)
4. DoD should formulate an overarching code of
military medical ethics.
• Medical Ethics Integrated Product Team Established
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Medical Ethics (cont.)
In the News
• AMA: Enteral feeding of hunger striking detainees
never justified
• APA: “psychologists shall not . . . assist any national
security interrogations.”
• APA: Based on reports of U.N. offices, “it is a
violation of APA policy for psychologists to work at”
GTMO unless “providing treatment for military
personnel.”
• Impact on medical/psychology boards ethics codes?
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Ethics (cont.): Law: Balance
Conscience & Mission
§ 533 NDAA-13, amended by § 532 NDAA-14: Protection of
rights of conscience of members of the Armed Forces
(1) “Unless it could have an adverse impact on military
readiness, unit cohesion, and good order and discipline, the
Armed Forces shall accommodate individual expressions of
belief of a member of the armed forces reflecting the sincerely
held conscience, moral principles, or religious beliefs of the
member. . . .”
(2) “Nothing in paragraph (1) precludes disciplinary or
administrative action for conduct that is proscribed by . . . the
Uniform Code of Military Justice, including actions and
speech that threaten good order and discipline.”
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. . . MHLN Research Helper . . .
Family Advocacy Program
• DoDI 6400.01 & DoDM 6400.01, Family Advocacy Program (2015)
Health Information Security
• DoDI 8580.02, Security of Individually Identifiable Health
Information in DoD Health Care Programs (8/12/15)
Law of War
• DoD Law of War Manual (6/2015):
http://www.dod.mil/dodgc/images/law_war_manual15.pdf
Medical Marijuana
• ASD(R&FM) memo 2/4/13 reaffirms federal policy
Military Health System
• DoDD 6010.04, Healthcare for Uniformed Services Members and
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Beneficiaries, 8/17/15
MHS Governance: DHA Pubs
DoDD 5136.13, Defense Health Agency, 9/30/13
Director, DHA has authority to: . . . [e]stablish and maintain . . . for functions
assigned, a DHA publication system for regulations, instructions, and
reference documents produced by the DHA. . . .
(1) The Director, DHA, must ensure that all OSD and DoD Components . .
. are given the opportunity to coordinate when such publication is written . . .
(2) For assigned functions, approved DHA publications are binding on
DoD Components.
____________________________________________________________
Defense Health Agency
PROCEDURAL INSTRUCTION
NUMBER 5025.01
August 21, 2015
SUBJECT: Publication System
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Nondiscrimination in the MHS
ACA § 1557: “[A]n individual shall not, on the ground
prohibited under title VI of the Civil Rights Act of 1964, title IX
of the Education Amendments of 1972, the Age Discrimination
Act of 1975, or section 504 of the Rehabilitation Act of 1973,
be excluded from participation in, be denied the benefits of, or
be subjected to discrimination under, any health program or
activity. . . administered by an Executive Agency . . . . The
enforcement mechanisms provided for and available under
such [statutes] shall apply. . . .”
• Prohibits discrimination: race, origin, sex, age, handicap
• Applies to both MTF care and purchased care
• Requires complaint procedure to remedy noncompliance
• Judicial remedies potentially available
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Nondiscrimination (cont.)
HHS Proposed Rule
• 80 Fed. Reg. 54172 (9/8/15)
• Focus on health access for those with limited
English proficiency
• Sex discrimination includes sexual
preference, gender identity, sex stereotypes
• Does not apply to employment discrimination
• Statute includes a private cause of action
• Each Federal agency responsible for its own
compliance
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Nondiscrimination (cont.)
Expected DHA-PI
• DHA Office of Privacy & Civil
Liberties will provide support
& assistance to MHS
components
• Each MTF will:
– Provide staff training
– Provide beneficiary
information
– Have an effective
complaint process for
investigating possible
violations
Defense Health Agency
PROCEDURAL INSTRUCTION
DRAFT NUMBER XX.XX
[Date]
------------------------------------------------------------------------------------------------------------
SUBJECT: Nondiscrimination in Military
Health System Programs and Activities
References:
See Enclosure 1
1. PURPOSE. Under the authority of DoD Directive 5136.13 (Reference (a)), this
Procedural Instruction promulgates guidance, assigns responsibilities, and
prescribes procedures for implementing in the Military Health System statutory
nondiscrimination requirements applicable to federally conducted and federally
assisted health programs and activities under section 1557 of the Patient Protection
and Affordable Care Act (Reference (b)).
3. POLICY.
a. As established by Reference (b), an individual may not unlawfully be denied the
benefits of, or be subjected to discrimination under, any MHS-conducted or MHSassisted health program or activity on the ground of:
(1) race or national origin prohibited under title VI of the Civil Rights Act of 1964
(Reference (c));
(2) sex prohibited under title IX of the Education Amendments of 1972
(Reference (d));
(3) age prohibited by the Age Discrimination Act of 1975 (Reference (e)); or
(4) disability prohibited by section 794 of title 29, United States Code (Reference
(f)).
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Psychological Health & Suicide
• NDAA-15, § 701 (10 USC § 1074n)
– Requires “a person-to-person mental health assessment”
annually for each member of a regular component and
each member of the Selected Reserve
– For deployed personnel, person-to-person mental health
assessment required every 180 days
• NDAA-15, § 523
– Requires info to all new recruits & officer candidates during
initial training & all members periodically on privacy rules
applicable to mental health services
– Covers HIPPA (DoD 6025.18R) and DoDI 6490.08
(command notification limits to dispel stigma)
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Active Duty Suicides For All Military Services & Components
1/1/2001 through 12/31/2012
400
Note: Orange total in 2012 shows expected suicides based on the 2001-2011 trend.
349
350
310
300
250
Number of Suicides
298
28
34
270
298
267
301
2010
2011
324.9
26
267
226
214
190
200
171
160
150
32
301
15
33
25
145
160
146
171
157
190
2001
2002
2003
195
189
24
41
171
195
27
26
188
34
284
310
317
233
267
199
226
214
148
189
100
50
0
Regular Suicides
2004
2005
Reserve Suicides
2006
2007
2008
Suicides YTD Each Year
2009
2012
Expected Number of Suicides YTD
Source: Mortality Surveillance Division, Armed Forces Medical Examiner (Contact: 302-346-8641)
. . . MHLN Research Helper . . .
Military Treatment Facilities
• DoDI 6015.23, Foreign Military Personnel Care and Uniform
Business Offices in Military Treatment Facilities, 2/23/15
Occupational Health
• DoDI 6055.01, DoD Safety & Occupational Health Program,
10/14/14
Professional credentials
• NDAA-15, § 523 (10 USC § 2015): authorizes DoD
regulations to allow payment of expenses to help members
obtain professional credentials
Service Treatment Record
• DoDI 6040.45, DoD Health Record Life Cycle Management
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Quality Assurance/Patient Safety
NYT 6/29/14, 9/2/14. p. 1
• “The military lags behind many
civilian hospital systems in
protecting patients from harm.”
• There is “an overall failure to make
patient safety a top priority.”
• 2011-2013: 239 unexpected deaths;
only 100 RCAs
• DoD Sentinel Event policy often not
followed. “[L]ast year, the [U.S.]
paid 21 military patients more than
$500,000 each to settle malpractice
claims, an indication of ‘significant
harm.’ Yet, hospitals identified only
three as sentinel events, a pattern
that has persisted for years.”
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SECDEF Memo 10/1/14
Access: “No patient should be told to
call back for an appointment.”
Quality: “I direct that . . . the DHA will
establish a MHS performance
management system (PMS) to . . .
monitor MHS-wide core measures and
dashboards. . . [to show]
improvements in all areas.”
Transparency: “[P]rovide all currently
available aggregate statistical access,
quality and safety information for all
MTFs . . . on health.mil.”
High Reliability Organization:
“ASD(HA) will lead development of a
specific plan to implement.”
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QA/PS (cont.)
NYT 4/19/15, p. 1
• Because of Feres, very few
AD case reports to the
NPDB
• From 2003 to 2009, military
reported 15 clinicians for
substandard care of AD
patients, 710 for those who
can sue – 47 times as many
• Since 2009, gap narrowed
to 17 times as many
• Because of Feres and 1102,
very little transparency
The New York Times
______________________________________________________
______________________April 19, 2015_____________________
Service Members Are Left
in Dark on Health Errors
By SHARON LaFRANIERE
FORT WAYNE, Ind. – Lt. Col. Chad Gallagher was T.J.
Moore’s squadron leader when the 19-year-old recruit
arrived at basic training last spring at Lackland Air Force
Base in San Antonio. He was watching at the quarter-mile
track nine days later when Mr. Moore, on an easy mile-anda-half test run, collapsed at the finish line and was rushed to
a hospital.
And he was in Indiana shortly afterward to deliver a
sorrowful eulogy at Mr. Moore's funeral. "He had tears in
his eyes," Mr. Moore's mother, Anita Holmes, said in an
interview at her home here. "He said, 'I didn't do enough to
protect T. J.' "
A year later, Ms. Holmes says she still does not know
what Colonel Gallagher meant by that.
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QA/PS: Sentinel Events
Policy: “MTFs shall actively identify sentinel events that occur
in their facilities, conduct a root cause analysis, and form a
corrective action plan for each event. The results ... shall be
promptly reported....”
New Sentinel Event Definition (per ASD/HA memo 3/12/15):
• TJC definition: A sentinel event is a patient safety event (not
primarily related to the natural course of the patient’s illness
or underlying condition) that reaches the patient and results
in death, permanent harm, or severe temporary harm; plus:
• National Quality Forum Serious Reportable Event List
– A long list of specific events
• New definition broader than old TJC reportable SEs, but not
including all “risk” of harm circumstances
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QA Program Developments
Under DoD 6025.13-M, Oct. 2013
• Refine § 1102 “aggregate statistical data” exception
to increase transparency at MTF level
– Expect routine FOIA releases of MTF quality data
• Follow same “accountability process” for Feresbarred cases (i.e., disability) as for paid claim cases
– MEBs flag possible QA issues for review
• Do root cause analysis of every Sentinel Event
– Now use new definition
• Requires disclosure to patients of accurate info
– Includes adverse events and unexpected outcomes
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QA/PS: Whadayado?
Scenario: Active duty member injured in
motor cycle accident, admitted to MTF
through ER. Retained sponge in surgery
causes infection, complicates recovery from
injuries. Later, MEB refers member to PEB
due to disability from motor cycle accident
injuries. DCCS asks for legal advice on
reviewing the care.
Whadayado?
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Research: New Common Rule
for Human Subjects Protection
• HHS Proposed Rule: 80 F.R. 53933 (9/8/15)
• Exempt internal program activities & reviews,
e.g. public health surveillance
• Reduce regulation of low risk activities
• Informed consent forms more user friendly
• Single IRB for multi-site research projects
• Greater protections for research with existing
biospecimens
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Transgender Issues
• SD Memo 7/13/15: Working group will start with the
assumption that transgender persons can serve openly without
adverse impact on military effectiveness and readiness, unless
and except where objective, practical impediments are
identified. . . . [W]e must ensure that everyone who’s able and
willing to serve has the full and equal opportunity to do so. . . .”
• DoDI 6130.03, “Medical Standards for Appointment,
Enlistment, or Induction in the Military Services,” 4/28/10
• DoDI 1332.14, “Enlisted Administrative Separations,” 1/27/14
• 10 USC 1079: no TRICARE for gender change surgery
• TRICARE regulation: gender dysphoria treatment not covered
• Supplemental Care Program: Generally follows TRICARE
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rules, but waiver available
. . . MHLN Research Helper . . .
Sexual Assault
• DoDI 6495.02, Sexual Assault Prevention & Response Program
Procedures, Change 7/7/15
• Senate NDAA-16, § 553: pre-emption of state law on restricted reporting
VA Budget and Choice Improvm’t Act, PL 114-41
• § 4002: VA “shall develop a plan to consolidate all non-Department
provided programs by establishing a new, single program to be known
as the ‘Veterans Choice Program’ to furnish hospital care and medical
services to veterans . . . at non-Department facilities”
Veterans Service Organizations
• SD Memo, “Installation Access and Support Services to VA-Recognized
VSOs/MSOs,” 12/23/14
Wounded Warriors
• DoDI 6010.24, Interagency Complex Care Coordination, 5/14/15
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RECAP: Whadayado?
– Patient Safety: Do Sentinel Event RCAs,
screen MEBs, embrace transparency
– Nondiscrimination: Have complaint process
– Budget: Follow the money
--------------------------------------------------------------
QUESTIONS?
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