Military Health Law Symposium: What's New in Military Health Law?

1. What’s New inMilitary Health Law? FOR THE MILITARY HEALTH LAW SYMPOSIUM John A. Casciotti DoD Office of General Counsel September 2015

2. Military Health Law: Who’s Who?Mr. Robert Taylor Hon. Jonathan Woodson, M.D. Acting General Counsel of DoD ASD for Health Affairs

3. Outline • Military Health Law Network Refresher • Whazup? • Big Issues in 2015 & 2016 • Budget & Sequestration • Discrimination in Health Care Programs • Quality Assurance & Patient Safety • Whadayado?

4. Military Health Law NetworkResearch Helperhttp://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

5. 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

6. Military Compensation & Retirement Modernization Com. • Establish 4-star Joint Readiness Command, identify Essential Medical Capabilities, increase MTF readiness-related workload • Replace current TRICARE with OPM-administered FEHBP-like plans • Reform ECHO to align with State Medicaid plans • Increase DoD-VA collaboration on medical records, pharmacy formularies, etc.

7. More Potential Budget Issues • Rx refills for chronic conditions out of retail • TFL now; Other retirees 10/1/15 • Approps Bills FY16 shortfall $.7 to $1.4B • Mil-to-Civ personnel conversions? • Modernization study resizing of some MTFs? • “OCO Gimmick” veto? • Back to sequestration? • Full year CR?

8. 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

9. 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.”

10. 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

11. 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?

12. 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.”

13. . . . 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 Beneficiaries, 8/17/15

14. 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 NUMBER5025.01 August 21, 2015 SUBJECT: Publication System

15. 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

16. 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

17. Nondiscrimination (cont.)Expected DHA-PI 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 MHS-assisted 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)). • 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

18. 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)

19. 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)

20. . . . 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

21. 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]astyear, 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.”

22. 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.”

23. QA/PS (cont.) NYT 4/19/15, p. 1 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-and-a-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. • 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

24. 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

25. 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 Feres-barred 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

26. 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?

27. 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

28. 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. . . .” • 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 • Supplemental Care Program: Generally follows TRICARE rules, but waiver available

29. . . . 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

30. RECAP: Whadayado? • Patient Safety: Do Sentinel Event RCAs, screen MEBs, embrace transparency • Nondiscrimination: Have complaint process • Budget: Follow the money -------------------------------------------------------------- QUESTIONS?