Casciotti- What`s New in Military Health Law

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What’s New in
Military Health Law?
FOR THE MILITARY HEALTH LAW SYMPOSIUM
John A. Casciotti
DoD Office of General Counsel
September 2014
Military Health Law: Who’s Who?
Hon. Stephen W. Preston
General Counsel of DoD
Hon. Jonathan Woodson, M.D.
ASD for Health Affairs
2
Outline
• Military Health Law Network Refresher
• Whazup?
• Big Issues in 2014 & 2015
– Quality Assurance & Patient Safety
– Budget & Sequestration
– Psychological Health & Suicide Prevention
• Whadayado?
3
Military Health Law Network
Research Helper
http://www.usuhs.mil/ogc/mhln
Appropriations
• HR 4870, DoD Appropriations Act 2015
• Continuing Resolution
Clinical Laboratory Improvements Act
• DoDI 6440.02, “Clinical Laboratory Improvement
Program (CLIP),” 5/29/14
Detainee Health Care
• DoDI 2310.08E, Medical Program Support for Detainee
Operations, 6/6/06
Disability Evaluation System
• http://warriorcare.dodlive.mil/disability-evaluation/ides/4
DoD Budget Proposals FY 15
• Consolidated TRICARE Health Plan
– Replacing triple option
– Copays higher than Prime, but less than Standard
– Freedom of choice of provider
– Save $3.9B FY15-19
• “TRICARE for Life” Enrollment Fee
• Pharmacy Copay Increases
– From current $5/17/34 & $0/13/43 phase to 2024:
$14/45/XX and $14/45/90
5
– SASC bill includes
More Potential Budget Issues
• Rx refills for chronic
conditions out of retail
– TFL now; Other retirees
2015
• Return of
sequestration?
– 6.6% reduction in FY16 from FY-15 level
• U.S. Family Health Plan
– GAO recommends
termination
• Military Compensation &
Retirement
Modernization
Commission
– Recommendations 2/1/15
6
Clinical Investigations Program
DoDI 6000.08, “Defense Health Program
Funding and Administration of Research and
Clinical Investigation Programs,” 1/22/14
• Requires Management Controls to ensure:
(1) Acceptance of non-federal support will be well documented and
transparent and avoid the appearance of impropriety.
(2) Can’t accept any compensation from any non-federal source for
duties within the scope of the CIP. Includes off-duty employment in
connection with a CI activity.
(3) Can’t accept honoraria in connection with a CI activity or direct
honoraria to third parties.
(4) Can’t direct use of funds of a non-federal entity except as
specifically provided by approved agreement.
7
Disability Evaluation System
• DoDI 1332.18 & DoDM 1332.18 “Disability
Evaluation System (DES),” 8/5/14
• Vol. 1: General
Information &
Legacy DES
Time Standards
– PEBLO ratio 1:34
• Vol. 2: Integrated
DES
– Codification &
housekeeping
8
. . . MHLN Research Helper . . .
Emergency Health Powers
• DoDI 6200.03, “Public Health Emergency Management
within DoD,” 3/5/10, Ch. 6/1/12
Health Promotion
• DoDI 1010.10, “Health Promotion and Disease Prevention,”
4/28/14
Medical Readiness
• DoDI 6025.19, “Individual Medical Readiness,” 6/9/14
Medical Marijuana
• ASD(R&FM) memo 2/4/13 reaffirms federal policy
9
MHS Governance: DHA Pubs
DoDD 5136.13, Defense Health
Agency, 9/30/13
Director, DHA has authority to: . . .
Establish 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,
changed, or revised.
(2) For assigned functions, approved
DHA publications are binding on DoD
Components.
Defense Health Agency
INSTRUCTION
DRAFT NUMBER 5025.01
[Date]
-----------------------------------------------------------------------------------------------------------SUBJECT: Publication System Program
References: See Enclosure 1
1. PURPOSE. This Instruction:
a. In accordance with Deputy Secretary of Defense Memorandum
(Reference (a)) and pursuant to the authority in DoDDs 5136.13 and 5136.01
(References (b) and (c)), this instruction implements policy, assigns
responsibilities and prescribes procedures for the development, coordination
and publication of Defense Health Agency (DHA) Publications.
b. Establishes the DHA Publication Website on the unclassified DHA Intranet
(.mil domain) and the Internet (public domain).
2. APPLICABILITY
a. OSD, the Military Departments (including the Coast Guard at all times,
including when it is a service in the Department of Homeland Security by
agreement with that Department), the Office of the Chairman of the Joint Chiefs
of Staff (CJCS) and the Joint Staff, the Combatant Commands, the Office of the
Inspector General of the Department of Defense, the Defense Agencies, the
DoD Field Activities, and all other organizational entities within the DoD (referred
to collectively in this instruction as the “DoD Components”).
b. The Commissioned Corps of the Public Health Service and the
Commissioned Corps of the National Oceanic and Atmospheric Administration,
under agreement with the Department of Health and Human Services.
c. In accordance with the authority in Reference (b), for assigned functions,
approved DHA publications are binding on DoD Components.
10
Psychological Health: Command
Directed Mental Health Evaluations
• DoDI 6490.4, Mental Health Evaluations of Members
of the Military Services, 3/4/13
• Implements NDAA-12, § 711: SECDEF to issue regs:
– “to eliminate perceived stigma associated with . . . mental
health services, promoting the use . . . on a basis
comparable to the use of other . . . services.”
• § 711 repealed § 546 of NDAA-93, which required
elaborate procedures for CDMHEs
– Keeps whistleblower protections, inpatient procedures
• Stigma still major issue
– DoDI 6490.08, Command Notification to Dispel Stigma.
8/17/11
11
Psychological Health & Suicide
• SASC Proposed NDAA-15, § 701
– Requires “a person-to-person mental health assessment”
annually for each member of a regular component and
each member of the Selected Reserve
– Purpose is to “identify mental health conditions” needing
treatment
• House-passed Proposed NDAA-15, § 701
– For deployed personnel, person-to-person mental health
assessment required every 180 days
• DoDI 6490.15, Integration of Behavioral Health
Services into Patient-Centered Medical Home
Primary Care & Other Primary Care Settings, 8/8/13
12
Psych Health: Whadayado?
Scenario: Mental health provider says to JAG: A
guy’s commander called me. He had referred
the guy to mental health but it wasn’t an order.
He wants me to tell him about the guy. The guy
is not a threat to self or others, but he has
problems. I’m not sure I should say anything.
What’s your advice? Choices:
a) Commander always has a need to know
b) Medical ethics require confidentiality
c) It depends
13
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)
Suicide Prevention:
Means Reduction
• Privately owned firearms
– USD(P&R) Memo, “Guidance for Commanders & Health
Professionals on Reducing Access to Lethal Means
Through Voluntary Storage of Privately-Owned Firearms,”
8/28/04
– Encourage voluntary storage; no incentives/disincentives
• Controlled Substances
– DEA Final Rule, “Disposal of Controlled Substances,” 79
FR 53,520, 9/9/14: Accepted DoD request to allow
registered MTF pharmacies to have collection receptacles
– MHS will implement broadly
15
Quality Assurance/Patient Safety
NYT 6/29/14, 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
• Featured several multi-million
dollar OB malpractice cases
16
QA/PS (cont.)
NYT 9/2/14, p.1
• 9 MTFs have ADPL < 10; Dr.
Lucian Leape says “they
should be outlawed.”
• DoD Sentinel Event policy
often not followed. “In fact, …
last year, the government 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.”
17
NYT (continued)
• MHS “has consistently had
higher than expected rates of
harm and complications” in
maternity care & surgery
• Data show several MHS medical
centers have higher than
expected surgical complications
• “and some hospitals perform
worse” than civilian benchmarks
“in multiple safety categories,”
some “over 2 times average”
• One take-away message:
MTF-specific performance data
transparency is the new normal
18
Report to SECDEF
•
•
•
•
•
Review of access,
quality, patient safety
Includes external experts
reviewing data & analysis
Comparisons to civilian
benchmarks
Comparison to high
performing civilian
systems
600+ page report
scheduled for publication
9/24/14
19
Sentinel Events: Whadayado?
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....”
Definition: “An unexpected occurrence
involving death or serious physical or
psychological injury or risk thereof.
Serious injury specifically includes loss of
limb or function. . . . Such events are
called ‘sentinel’ because they signal the
need for immediate investigation and
response.”
“Military Health System
Patient Safety
Program: A Legal
Foundation for
Preventing Medical
Errors”
– Root cause
analysis
preventive, not
punitive
20
Feres Doctrine
Rationale for Feres:
• Workers Comp premise
• Equity for all disabled
members & survivors
• Good order and discipline
• Quality of care not based
on tort litigation
• Accountability not based on
tort litigation
• Defensive medicine would
impair MHS mission
_______________No. 13-893_____________
Ritchie v. U.S.
BRIEF FOR THE UNITED STATES IN OPPOSITION
__________________________________________________
• cert. denied 5/5/14
In the Supreme Court of
the United States
_____________________________________
JONATHAN RITCHIE, PETITIONER
v.
UNITED STATES OF AMERICA
______________
ON PETITION FOR A WRIT OF CERTIORARI
TO THE UNITED STATES COURT OF APPEALS
FOR THE NINTH CIRCUIT
______________
Quality Assurance Program:
DoD 6025.13-M, Oct. 2013
•
•
•
•
•
•
•
•
Implement stat. changes to licensure portability
Adopt credentialing by proxy for telemental health
Revise § 1102 standards to increase transparency
Follow same “accountability process” for Feresbarred cases (i.e., disability) as for paid claim cases
Reinforce NPDB reporting w/in 180 days
Improve reporting of Sentinel Events
Establish patient opportunity to be heard
DoD-wide Healthcare Resolutions Program
22
Sexual Assault Prevention &
Response
NDAA 14, § 1725(b):
• At least 1 Sexual Assault Nurse Examiner
(SANE) assigned to every MTF with 24/7 ED;
• Other MTFs must make SANE services
available (report language says in MTF)
• SD sets training and certification requirements
DoDI 6495.02, “Sexual Assault Prevention and
Response Program Procedures,” 3/28/13
• Encl. 7, Healthcare Provider Procedures 23
Transgender Issues
• EO 13672 (7/21/14) amended prior EOs on Fed. employee (EO
11478) and Federal contractor (E.O. 11246) nondiscrimination
– Prohibits discrimination based on “gender identity”
– For contractors, Sec-Labor shall do regulations within 90 days
• HHS: gender discrimin. prohibition includes gender identity
• VA now has Transgender Treatment Program
• 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
24
Veterans Affairs Sharing
• DTM 14-006, “Separation History and Physical
Examination (SHPE),” 7/7/14
– All members serving > 180 days get DoD or VA SHPE
before separation; implements 10 USC §1145(a)(5)
• SD Memo 6/23/14, Service Treatment Records to VA
– Health Artifact & Image Management Solution (HAIMS)
“taking too long”; take corrective action; 45 day goal
• NDAA-14 § 525: STRs to VA = HIPAA allowed disclosure
• Veterans Access, Choice, and Accountability Act of 2014
– Expands VA services from non-VA providers (incl. DoD)
• Approps. Act § 8061: don’t support agency >90 days in
arrears without SD national security waiver
25
. . . MHLN Research Helper . . .
Outpatient Food & Beverages
• DoDI 6025.24, “Food & Beverages to Certain Members &
Dependents Not Receiving Inpatient Care at MTFs,” 3/7/14
Personal Services Contracts
• DEA Registration rules same as for civilian employees
Suicide Prevention
• DoDD 6490.14, “Defense Suicide Prevention Program,” 6/18/13
Wounded Warriors
• DTM 14-004, “Interim Guidance on Personal Acceptance of
Gifts from Outside Sources for Combat-Related or Similar
Injuries or Illnesses,” 4/17/14
• DoD-VA MOU Interagency Complex Care Coordination, 7/29/14
26
RECAP: Whadayado?
– Patient Safety: Do Sentinel Event RCAs
– Psych Health: Reduce stigma
– Budget: Follow the money
---------------------------------------------------------------
QUESTIONS?
27
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