2013 Federal Health Law Course Uniformed Services University of the Health Sciences

1. 2013 Federal Health Law Course Uniformed Services University of the Health Sciences Jodye Marvin Senior Trial Counsel Torts Branch, FTCA Staff, Civil Division (202) 514-0353; Joanne.Marvin@usdoj.gov

2. 2013 New Director, Torts Branch, FTCA Staff: James (Jim) G. Touhey, Jr. The FTCA Staff: • Develops and provides FTCA subject matter expertise • Litigates cases presenting unique issues • Ex: Application of Statutes of Repose in FTCA cases • Reviews and comments on proposed legislation that may impact application of the FTCA

3. FTCA Staff Relationship withAgency Counsel and AUSAs • When requested, the FTCA Staff provides guidance regarding claim evaluation and settlement. • After claimants have agreed upon settlement terms, the FTCA Staff reviews and makes recommendations regarding requests for settlement authority

4. The O’Connor Memorandum Encourages Early Consultation with the FTCA Staff, and provides a framework and guidelines. • Request Assignment of an FTCA Staff Attorney • Consult on Issues that Require FTCA Staff Support or Approval: • admission of liability • raising or waiving certain defenses • participation in settlement conferences • settlement strategy and evaluation

5. Informal Valuation • Seek prior to settlement negotiations • Know in advance what the FTCA Staff will support, including any required terms or structure of a settlement • Confirm document requirements in advance

6. FTCA Settlement Components • Model FTCA Settlement Documents • Settlements may be all cash, or they may be structured, using annuities to replace lost income streams or to fund a Reversionary Medical Claims Trust. • Annual list of approved Structured Settlement Brokers • Brokers submit medical records to annuity companies, which provide claimant specific rated ages and annuity costs. • Special Needs Trusts are highly disfavored and should not be part of an FTCA settlement.

7. Negotiation of Settlement • Consider making offers in the context of the model settlement documents. • If the terms of the standard documents seem inapplicable based upon the facts of the case and/or the jurisdiction’s applicable law, counsel should be prepared to articulate the reasonssuch terms or provisions are not applicable.

8. Written Request for Settlement Authority • The request must be made by the appropriate agency authority, not by local or regional counsel. • Include the name and phone number of the counsel who has prepared and is most familiar with the request. • Articulate positions for which you seek support and authority, especially if you advocate deviations from standard documents and policies. • Include comparable judgments and settlements (full cites). • Include the required settlement documents, signed by claimants and their counsel, but not by government counsel.

9. Content and Organization of the Cover Page Summary information necessary for prompt review and assignment of the request: 1. Subject • Claimants • Location/Jurisdiction • Amount and terms of authorization sought 2. Time Limits: Any deadlines 3. Summary of Claim: • Example: “This is a medical malpractice claim based upon care provided at a military community hospital, alleged to have resulted in brain damage to an infant during childbirth.”

10. Content and Organization of the Written Request 1. Factual Background • Employment status/FTCA coverage for care providers • Relevant chronology of events • Nature and extent of the injury • Subsequent medical care to date • Current medical condition 2. Procedural History • Date and amount of claim filings • Procedural history/negotiations

11. Written Request, con’t. 3. Liability • Subject matter jurisdiction issues, if any • Relevant state law regarding elements of liability • Plaintiff and Defense positions and supporting evidence • Discuss strength of those positions Other applicable issues, and how they are addressed in the settlement: Contributory negligence, comparative negligence, loss of chance, joint and several liability, contribution, indemnification, insurance, co-tortfeasors, lien or claim holders

12. Written Request, con’t. 5. Analysis and Negotiations • Case- and jurisdiction-specific factors • Negotiating history of value and terms • Offers, counteroffers 6. Measures taken to enhance likelihood of finality • Signatories • Necessary court orders • Releases and Waivers

13. Consultation with the FTCA Staff during the Ad Claim stage is required when: • a new precedent or point of law is involved; • a question of policy is or may be involved; • there may be an affirmative indemnity or contribution claim which the agency is unable to adjust; or • the resolution of a particular claim will or may control the disposition of a related claim that may exceed the agency’s delegated settlement authority.

14. Dispute Resolution Techniques:Limitations on Agency Authority28 C.F.R. 14.6 • 14.6 (a)(1) Whenever feasible, administrative claims should be resolved through informal discussions, negotiations, and settlements rather than through the use of any formal or structured process. • The use of more formal ADR processes during the Ad Claim stage should be infrequent and reserved for extraordinary circumstances. • 14.6 (b)(1) Before using more formal ADR processes to facilitate “resolution of disputes that are in excess of the agency’s delegated authority,” counsel must seek approval from the Attorney General’s designee for the settlement authority sought.

15. 28 C.F.R. 14.6 This request should be made in a Memo to the Director, Torts Branch justifying the request: • The basis for concluding there is FTCA liability • Description of the proposed ADR process • How its use is warranted in the context of the claim • Analysis of the likelihood that its use will contribute to the prompt, fair, and efficient resolution of the claim • Statement re: • Claimant’s consent to the proposed form of ADR, • their agreement as to sharing the additional cost, • and the manner and timing of payment of those costs.

16. Explain how the requested action would facilitate resolution. • Confirm the parties’ understanding of the non-binding nature of any determinations made as a result of the proceeding. • Provide an estimate of the potential range of possible settlements considered likely to result from use of the proposed ADR process. • The agency will be notified of the decision made by the Attorney General’s authorization designee.

17. Ad Claims Processing by the FTCA Staff • The majority of claims received by the FTCA staff are transferred “to the appropriate agency” (about 50 new claims per month). • Pursuant to § 14.2 (b)(1) of 28 C.F.R., “[a] claim shall be presented to the Federal Agency whose activities gave rise to the claim.” • When a claim is presented to any other Federal agency, that agency shall transfer it forthwith to the appropriate agency, if the proper agency can be identified from the claim, and advise the claimant of the transfer. • “If transfer is not feasible the claim shall be returned to the claimant.”

18. The FTCA Staff also retains and makes determinations for claims involving various entities that have no - or limited - delegated settlement authority (about 25 new claims per month). • If a claim involves an employee of a U.S. Attorney’s Office, the FTCA Staff will handle the claim regardless of what other agencies are involved.

19. Issues in Health Care Claims • Records • What constitutes the “complete” records? • Who can identify, locate, and interpret the complete records? • It should not be assumed that care providers/fact witnesses will be able to explain how they are organized. • Who knew what and when something happened? • Adverse inferences may be made based upon the timing of entries and incomplete records. • They may indicate or “suggest” an apparent lack of communication up and down the chain of care providers. • In the absence of documentation, they may support a perceived lack of communication with patient and family members.

20. Life Care Plans & Planners What is a Life Care Plan? • A “dynamic document” based upon: • Published standards of practice • Comprehensive assessment • Data Analysis • Research The Life Care Planning and Case Management Handbook, Third Edition (September 2009, CRC Press)

21. What is their purpose? • The stated purpose of LCPs is to provide an organized and concise plan for current and future needs and associated costs; • For individuals who have experienced catastrophic injury or who have chronic healthcare needs.

22. How Long Have LCPs Been Around? The concept of life care planning emerged in the 1980s, pioneered most notably by Paul M. Deutsch, PhD, and others. An on-line search of his name coupled with the term Life Care Plan will lead you through the development of the field.

23. LCPing evolved primarily within the field of litigation support. When its use expanded to non-litigation treatment settings, such as elder care, chronic illness, and discharge planning, those in the field recognized that the need for standards of practice became “more critical.” That recognition suggests that perhaps standards of practice are not considered so critical for use of LCPs in claims and litigation support.

24. What is Life Care Planning? Is it a Medical Specialty? • Not exactly. For the answer to that question, we can turn to the website for one of the early “distance” LCPing learning programs: “Life Care Plans are used most commonly as a litigation tool; to settle cases or to set medical reserves for the insurance carriers.” • Listed as “most likely” client markets include “Personal Injury Attorneys, Medical Malpractice Attorneys, Health Care Attorneys or Rehabilitation Providers and Insurance Carriers.” • The site also notes that “Life Care Planning is a consultation specialty for many health professionals.” http://www.distance.ufl.edu/lcp

25. Who Prepares Life Care Plans? • Life Care Planners have varied credentials and experience. • There is no established requirement for certification, but at least two credentialing organizations certify Life Care Planners: • The International Commission on Health Care Certification (CHCC); http://www.ichcc.org • Requires a 120-hour training program • The Certified Nurse Life Care Planner Certification Board; http://www.aanlcp.org

26. Individual Life Care Planners tend to prepare plans at the request of plaintiffs or defendants, seldom both. • There often is less difference than you might expect between plaintiff and defense LCPs. • The initials CLCP, sometimes seen after their name and other affiliation abbreviations, stands for Certified Life Care Planner (CLCP). To qualify, candidates must complete a pre-certification program, and meet the underlying certification requirements for their area of specialty.

27. How rigorous are these training programs? • For example, the University of Florida’s on-line Distance Learning pre-certification program: • Candidates must complete five courses, • each costing $550, • which they may take up to three months each to complete.

28. They then must attend a two-day residential institute in Orlando. The Institute includes chances to: • apply knowledge and skills learned in the courses, • experience consultation and testimony scenarios, and • work through exercises in ethical decision making.

29. What subjects do the courses cover? • Professional Orientation to Life Care Planning • Spinal Cord Injury: Adult and Pediatric • Brain Injury: Adult and Pediatric • Amputations: Adult and Pediatric • Multiple Physical and Psychological Disabilities • Standards, Case Management, Ethics, and Expert Testimony in Life Care Planning

30. Other schools, including Georgia State University and the Medical College of Virginia, Virginia Commonwealth University, have similar programs within their Departments of Rehabilitation. • References to any LCPrs and programs are neither endorsement of their services nor criticism of their programs.

31. Is there a “bedrock” LCP requirement ? Life Care Plan recommendations must each be backed by a medical doctor in a related specialty. The Life Care Planning literature broadly recognizes the concept that regardless of a particular LCPr’s specialty, no single LCPr has the breadth of expertise to complete a LCP w/o drawing upon the skills of experts from a broad range of professionals.

32. How do they do this? They should be doing this through consultation, interaction with the treating physicians and allied health team members, and use of . . . clinical practice guidelines as well as the research literature.” To not do so “is to underestimate the complexity and purpose of the Life Care Planning process.” • http://www.paulmdeutsch.com/LCP-introduction

33. But not consulting with others is not necessarily fatal to a LCPr’s testimony or persuasiveness: • M.D.P. v. Middleton, 925 F. Supp. 2d 1272 (M.D. Ala. 2013) (2013 WL 599538) • Defendants were unsuccessful in their efforts to exclude the testimony of a life care planner, a doctor, on the basis that his projections in the case lacked a credible basis because he did not consult with a group of other physicians.

34. What do Life Care Plans Include? • Projected care is grouped by topics such as: • evaluations • therapies • counseling (behavioral, occupational, physical, speech) • orthotics and prosthetics • home furnishings and accessories • transportation • computer systems and educational software • medical care and medications • annual MRIs to “monitor” neurological injury • home care, facility care, case management • homemaker, housekeeper, home and lawn maintenance

35. What should we remember about LCPs? • They are measuring tools for plaintiffs’ potential future care needs and costs. • They are not prescriptions to be filled and funded. • They often are more like “catalogues” of all forms of medical care, equipment, and supplies that could possibly be used over a full natural lifetime (think U.S. Life Tables).

36. They tend to be less “tailored” than they may appear. Look for telltale signs of “write-overs,”such as wrong names, gender, date of birth, age. • They increase plaintiffs’ damages expectations, in part by increasing their worries about how they will care for the injured family member, cover their health care costs, and deal with this “what if” worst case scenario ahead. • What will happen to my injured child or spouse when I can no longer care for them?

37. How is LCP information used? • LCPs are used in conjunction with: • Life expectancy projections • Treating and expert doctors • Life expectancy experts • Economists’ calculations as to costs over time, reduced to present value; • Make sure they don’t include mutually exclusive care items, such as family-home-based care and care provided in an institution during the same time period. • Structured settlement brokers’ projections as to the cost of annuities to support future medical costs.

38. Often LCP issues are intertwined with collateral source issues. • Shelley v. White, 711 F.Supp.2d 1295, (M.D. Ala. 2010). • Howell v. Hamilton Meats & Provisions, Inc., 257 P.3d 1130, (2011), reh’g denied (Nov. 2, 2011). • Pease v. Lycoming Engines, 4:10-CV-00843, 2012 WL 162551 (M.D. Pa. Jan. 19, 2012) • To be persuasive on the issue of set-offs for other government benefits claimant may receive, evidence regarding the source of those benefits must be developed and presented. • Smith v. United States, 3:09-CV-249, 2012 WL 3017704 (W.D. Pa. July 23, 2012)

39. How Much Credibility Do LCPs Have with Courts? • They can’t be ignored. Unchallenged, claimants’ LCPs are the only evidence before the court on future damages. • Juaire v. United States, 4:09-CV-709-TLW, 2012 WL 527598 (D. S.C. Feb. 16, 2012) • Defense objections should address the underlying medical necessity, not just the costs. • Jacobs v. United States, 10 CV-0479 TUC AWT, 2013 WL 3282082 (D. Ariz. June 18, 2013) • Courts are reluctant to place the risk of worst case scenarios on the shoulders of claimants.

40. Courts are reluctant to place claimants in a position where they must rely on care in government facilities. • Feeley v. United States, 337 F.2d 924, 934-5 (3d Cir. 1964) (holding that setting off an FTCA award by the amount of care plaintiff would receive in the future from the VA “would result in forcing the plaintiff, financially speaking, to seek only the available public assistance. Private medical care would be obtained at the plaintiff's own expense. We think that is an unconscionable burden to place on the plaintiff”).

41. Challenging Claimant’s LCP • Challenge the LCPr’s credentials and experience. • Keep in mind the credentials and experience of the defense LCPr, if any. • Challenge the extent to which recommendations are specific and appropriate for this claimant. • Are they related to injuries for which the U.S. is liable? • Are they based upon sound medical assessments and need? • Has the LCP become outdated by the passage of time? Are the recommendations no longer valid based upon documented changes in claimant’s condition?

42. Cautions Re: identifying a “defense” LCPr at the Ad Claim Stage • Identifying a “defense” LCP/r at this stage, without the benefit of discovery or disposition of any legal defenses, establishes a “floor” for claimants’ expectations re: future medical costs. • Prepare to hear “even the defense LCPr” agrees that claimant/ plaintiff’s future medical costs for “y” and “z” will be “x.” • They may require “rehabilitation” in light of new information if the claim proceeds to litigation. Even if they are not named as a witness, the AUSA may have to deal with their “ghost.” • Consider a consulting or testifying medical expert in a core field related to claimant’s injuries to challenge claimant’s LCP.

43. How can we challenge underlying assumptions and show why they don’t apply to this claimant? • Are projections made for claimant’s “full” life expectancy (LE)? • LCPrs usually leave it to others to make LE projections. • Show the impact of using claimant-specific LE projections.

44. Compare early and updated life care plans. • Have projected needs changed? • Are projections consistent with the medical records? • Due to the passage of time, are some of the projections for future medical care now past medical care? Are they accounted for twice in the total damages calculations?

45. Use medical and school records to compare LCP recommendations to actual medical care usage and to cognitive and physical development during early years. • Track usage and the sources of payments for early care. • Examples: • TriCare, a government entitlement program (not insurance), for eligible active duty and retired military members and their eligible dependents • IDEA until age 22

46. Individuals with Disabilities Education Act (IDEA); 20 U.S.C. 1400 et seq.; 34 CFR Parts 300 and 301. • Until they are 22 years old, individuals with disabilities are entitled to free appropriate public education (FAPE) in the least restrictive environment. • Before age 3, there may be other early intervention programs.

47. At age 3, children are eligible to participate in the IDEA program. • The Individual Education Plan (IEP) is the cornerstone for IDEA compliance. • The first IEP is prepared at age 3. • Are the LCP recommendations consistent with the IEP, or earlier intervention plans for toddlers, and their underlying assessments?

48. Which LCP recommendations are part of the IEP? • Occupational, Physical, Speech, and other therapies • Attendant care, at the required skill level, while at school • Make a separate request for the IEP.

49. Identify a teacher or administrator at plaintiff’s school who can confirm services and frequency of services provided, and testify if necessary. • Are IEP descriptions of the child’s attentiveness and progress in school consistent with LCP recommendations?