What’s New in Military Health Law? FOR THE MILITARY HEALTH LAW SYMPOSIUM John A. Casciotti

1. What’s New inMilitary Health Law? FOR THE MILITARY HEALTH LAW SYMPOSIUM John A. Casciotti DoD Office of General Counsel September 2014

2. Military Health Law: Who’s Who?Hon. Stephen W. Preston Hon. Jonathan Woodson, M.D. General Counsel of DoD ASD for Health Affairs

3. Outline • Military Health Law Network Refresher • Whazup? • Big Issues in 2014 & 2015 • Quality Assurance & Patient Safety • Budget & Sequestration • Psychological Health & Suicide Prevention • Whadayado?

4. Military Health Law NetworkResearch Helperhttp://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/

5. 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 • SASC bill includes

6. More Potential Budget Issues • Rx refills for chronic conditions out of retail • TFL now; Other retirees 2015 • U.S. Family Health Plan • GAO recommends termination • Military Compensation & Retirement Modernization Commission • Recommendations 2/1/15 • Return of sequestration? • 6.6% reduction in FY-16 from FY-15 level

7. 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.

8. 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

9. . . . 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

10. MHS Governance: DHA Pubs 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. 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.

11. 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

12. 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

13. 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: • Commander always has a need to know • Medical ethics require confidentiality • It depends

14. Note: Orange total in 2012 shows expected suicides based on the 2001-2011 trend. Source: Mortality Surveillance Division, Armed Forces Medical Examiner (Contact: 302-346-8641)

15. 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

16. 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

17. 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.”

18. 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

19. 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

20. 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

21. 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 Ritchie v. U.S. • cert. denied 5/5/14 _______________No. 13-893_____________ 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 ______________ BRIEF FOR THE UNITED STATES IN OPPOSITION __________________________________________________

22. 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 Feres-barred 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

23. 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

24. 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 • DoDI6130.03, “Medical Standards for Appointment, Enlistment, or Induction in the Military Services,” 4/28/10 • DoDI1332.14, “Enlisted Administrative Separations,” 1/27/14 • 10 USC 1079: no TRICARE for gender change surgery • TRICARE regulation: gender dysphoria treatment not covered

25. 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

26. . . . 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

27. RECAP: Whadayado? • Patient Safety: Do Sentinel Event RCAs • Psych Health: Reduce stigma • Budget: Follow the money --------------------------------------------------------------- QUESTIONS?