kaitlyn samuels v department of defense

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    IN THE UNITED STATES DISTRICT COURT

    NORTHERN DISTRICT OF TEXAS

    DALLAS DIVISION

    KAITLYN SAMUELS, and

    CAPTAIN MARK SAMUELS, USNR, andJENNIFER SAMUELS, as conservators and

    guardians of KAITLYN SAMUELS,

    Plaintiffs,

    v.

    U.S. DEPARTMENT OF DEFENSE

    1400 Defense PentagonWashington, DC 20301,

    DEFENSE HEALTH AGENCY

    7700 Arlington Boulevard, Suite 5101Falls Church, VA 22042

    and

    CHUCK HAGELUnited States Secretary of Defense

    1000 Defense Pentagon, Room 3E880

    Washington, DC 20301,

    Defendants.

    Case No. __________

    COMPLAINT FOR

    DECLARATORY AND

    INJUNCTIVE RELIEF

    COMPLAINT FOR INJUNCTIVE AND DECLARATORY RELIEF

    Plaintiffs Kaitlyn Samuels, and Captain Mark Samuels and Jennifer Samuels, as

    Kaitlyns conservators and guardians, file this Complaint for Injunctive and Declaratory Relief

    against Defendants the Defense Health Agency1 (DHA) and Chuck Hagel, United States

    Secretary of Defense, in his official capacity, alleging as follows:

    1 On October 1, 2013, the Department of Defense established the Defense Health Agency (DHA) tomanage the activities of the Military Health System. These activities include those previously managed by

    TRICARE Management Activity (TMA), which was disestablished on the same date. Because TMA was

    administering the Military Health System when Kaitlyns benefits were denied, the Complaint will refer to TMA

    rather than DHA.

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    2

    NATURE OF THE ACTION

    1. Mark Samuels, United States Navy Reserve, and Jennifer Samuels, on behalf of

    their daughter Kaitlyn Samuels, bring this action under the Administrative Procedure Act

    (APA), 5 U.S.C. 702 (2006), challenging TRICARE Management Activitys (TMA) denial

    of cost-sharing for necessary, life-saving physical therapy for Kaitlyn. Plaintiffs assert that

    TMAs decision was arbitrary, capricious and unsupported by any substantial evidence. Plaintiffs

    request that this Court enjoin Defendants from denying coverage for Kaitlyns physical therapy

    and order Defendants to provide reimbursement for past physical therapy sessions, which were

    wrongfully denied.

    2. The TRICARE Basic Program is a supplemental program to the Uniformed

    Services direct medical care system. Beneficiaries receive coverage for necessary medical

    services and treatment strategies, including physical therapy.2

    3. Kaitlyn is a 17-year-old girl and TRICARE beneficiary who suffers from severe

    mental and physical impairments caused by agenesis of her corpus callosum. Due to Kaitlyns

    brain disorders, her muscles do not function properly. She also suffers from neuromuscular

    scoliosis, a medical condition that causes her spine to curve from side to side. Jennifer Samuels

    has three simple wishes for her daughter, Kaitlyn: that she learn to say a few words, take a few

    steps unassisted, and curl the food from her plate onto her spoon.

    2An Authorized Individual Plan of Care is the document that states a TMA patients health deficits that

    need treating, as well as the physical therapists doctor-prescribed, Current Procedural Terminology (CPT) codedtreatment strategy. Kaitlyns treatment strategy calls for physical therapy. The two CPT codes Kaitlyns physical

    therapist uses for her treatment are billed under 97530 Therapeutic Activities whereby the health care provider

    uses dynamic therapeutic activities designed to achieve improved functional performance (e.g., lifting, pulling,bending), and 97110 Therapeutic Exercises whereby the therapist and patient use a tool to perform therapeutic

    exercises to one or more body areas to develop strength, endurance, and flexibility. A Plan of Care determines

    treatment strategy, not the tools the therapist uses when executing the treatment strategy; indeed, there are no codes

    for tools.

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    4. If untreated, Kaitlyns disorder will severely worsen the curvature of her spine,

    which will cause compression of her ribs into her internal organs and crush her organs. Kaitlyns

    body will slowly shut down and she will die.

    5. Participation in effective physical therapy slows down and reverses negative

    effects of the curvature in Kaitlyns spine. Currently, Kaitlyns spine is straightening, and the

    surrounding muscles are growing stronger, because of the uniquely tailored physical therapy plan

    implemented by her physical therapist. Without specially tailored physical therapy, Kaitlyns

    only option would be an expensive and extremely risky surgery, which would involve fusing her

    backbone from the neck to the lumbar region. As a result of this surgery, Kaitlyn would lose the

    progress shes made to-date, as well as what freedom she has to move freely: she would lose all

    flexibility from her torso and would require nonstop monitoring. Simple tasks such as assisted

    walking, unassisted sitting, and sleeping comfortably would be impossible. This life-threatening

    and costly surgery may need to be repeated throughout her lifetime and will likely result in

    constant muscle spasms and pain. Under Kaitlyns physical therapy regimen this surgery will not

    be necessary.

    6. Kaitlyns doctors first prescribed physical therapy to Kaitlyn when she was an

    infant under one-year old. Since then, she and her parents have worked with a licensed physical

    therapist to treat and manage her condition through doctor-prescribed physical therapy. In her

    early childhood, Kaitlyn received physical therapy in a clinical setting using tools such as barrels

    and physioballs to engage her in various therapeutic activities. Eventually these tools proved

    ineffective because Kaitlynwhose intellectual capacity is in the high infant-toddler-preschool

    rangelost interest and would no longer participate. Like many special-needs patients receiving

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    physical therapy, Kaitlyn needed a regimen specifically tailored to meet her unique needs and to

    accomplish the goals of her physical therapy.

    7. Kaitlyns physical therapist performs therapy at a local wounded warriors

    treatment center near Kaitlyns fathers military base, where horses are readily and often

    available to be used as physical therapy tools for children like Kaitlyn and other physical therapy

    patients in the military such as wounded warriors. When physical therapy bolsters and balls

    proved ineffective for Kaitlyn, her physical therapist decided to incorporate therapeutic

    movements that could be performed on horseback. In 2006, under the supervision and direction

    of her physical therapist, Kaitlyn was placed on a horse while volunteers secured her ankles and

    knees and led the horse in a circle. The horses movements successfully engaged Kaitlyns back

    and trunk muscles, and she remained engaged in the activity for the entire 45-minute weekly

    session, a stark contrast to her lack of engagement with the barrels and physioballs. The horse is

    the only physical therapy tool which has proven effective for treating Kaitlyns scoliosis and the

    sessions were covered as any other physical therapy session by TRICARE until 2010.

    8.

    In June of 2010, TMA informed Captain and Jennifer Samuels that Kaitlyns

    physical therapy claims from April 23, 2009 through March 31, 2010, were being retroactively

    denied because the service provided was not a covered benefit under TMA policy. TMA

    contended that Kaitlyn was not receiving physical therapy, but was instead receiving an

    unproven treatment known as hippotherapy.

    9. The Samuelss appealed TMAs decision, and after a series of appeals, an

    administrative law judge conducted a full evidentiary hearing before concluding that Kaitlyns

    physical therapy was a covered.3 The judge determined that the horse was simply a tool for

    3SeeAppendix B.

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    physical therapy and rejected TMAs position that using a horse for physical therapy transformed

    the activity into an uncovered modality of treatment.4

    10. Disregarding the ALJs recommendation and analysis of the law and regulations,

    a TRICARE administrator who is neither a doctor nor a lawyer issued Kaitlyn a Final Decision

    on October 24, 2012, declaring that TMA would not cover her treatment. TMA denied Kaitlyns

    claims for benefits on the ground that her therapy was hippotherapy and not physical therapy,

    and because hippotherapy was not a proven and covered treatment, her benefits would cease.5

    TMA denied further treatment and demanded back payment for previously covered physical

    therapy sessions.

    11. TMAs decision was devoid of reason and unsupported by any substantial

    evidence or basis in the law. TMA provided no explanation of its decision that physical therapy

    utilizing a horse, in place of a therapy ball, barrel, wedge or other tool, is anything but physical

    therapy. Nothing in TMA regulations provides that the government may deny physical therapy

    based on the physical therapy tool selected by the therapist. It is only the treatment strategy

    itselfphysical therapythat may be denied. Consequently, TMAs decision was arbitrary and

    capricious and was plainly insufficient under APA standards.

    JURISDICTION AND VENUE

    12. This Court has jurisdiction under 28 U.S.C. 1331 as this action arises under 10

    U.S.C. 1079 (2006) and the APA, 5 U.S.C. 701 et seq., which grants judicial review of final

    agency action.

    4The word modality is not to be confused with a treatment strategy for the purposes of TMA benefits.

    TMA defines a modality as, Any physical agent applied to produce therapeutic changes to biologic tissues; includes

    but not limited to thermal, acoustic, light, mechanical, or electric energy. Examples include hot/cold packs,ultrasound, electrical stimulation. These are billed for in code in addition to direct treatment by the physical

    therapist. The ALJ recognized that Kaitlyn does not receive modalities in her physical therapy, [Kaitlyns] use of

    the horse is not a modality, but a physical therapy tool.5SeeAppendix C.

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    13. Venue is proper in this Court under 28 U.S.C. 1391(e) as this is an action

    against an agency of the United States, Plaintiffs reside in this judicial district, and a substantial

    part of the events and omissions giving rise to this action occurred, or a substantial part of

    property that is the subject of the action is situated, in this judicial district.

    14. This Court may grant declaratory relief under 28 U.S.C. 2201 and injunctive

    relief under 28 U.S.C. 2202, and shall hold unlawful and set aside agency actions, findings,

    and conclusions found to be (A) arbitrary, capricious, an abuse of discretion, or otherwise not in

    accordance with law; . . . (C) in excess of statutory jurisdiction, authority, or limitations, or short

    of statutory right, [or] (D) without observance of procedure required by law. 5 U.S.C.

    706(2)(A), (C), and (D).

    PARTIES

    Plaintiffs

    15. Plaintiffs are Kaitlyn Samuelsa 17-year-old girl who suffers from severe mental

    and physical impairmentsand her parents and conservators Captain Mark Samuels, USNR, and

    Jennifer Samuels. Kaitlyn is a TRICARE beneficiary. The Samuels family is located in Keller,

    Texas.

    Defendants

    16. The United States Department of Defense (DOD), located at 1400 Defense

    Pentagon, Washington, DC 20301, is an agency of the United States government.

    17. Defense Health Agency (DHA), located at 7700 Arlington Boulevard, Suite

    5101, Falls Church, Virginia 22042, is responsible for managing the Department of Defenses

    TRICARE health care system for active duty and retired uniformed service members and their

    families.

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    18. Chuck Hagel currently serves as the United States Secretary of Defense and is

    located at 1000 Defense Pentagon, Room 3E880, Washington, DC 20301. The Secretary of

    Defense has delegated authority to the Assistant Secretary of Defense for Health Affairs to

    provide policy guidance, management control, and coordination as required for all Department of

    Defense health and medical resources and functional areas, including health benefit programs.

    Nonetheless, Secretary Hagel maintains ultimate authority, direction and control over the

    Department of Defense, including the TRICARE health benefits program.

    STATUTORY AND REGULATORY PROVISIONS SUPPORT COVERAGE

    19.

    The TRICARE Basic Program is a supplemental program to the Uniformed

    Services direct medical care system. Although it is not an insurance program, the Basic Program

    is similar to private insurance programs and is designed to provide financial assistance to

    TRICARE beneficiaries for certain prescribed care from civilian sources. 32 C.F.R. 199.4(a).

    The stated purpose of the program is to create and maintain high morale in the uniformed

    services by providing an improved and uniform program of medical and dental care for members

    and certain former members of those services, and for their dependents. 10 U.S.C. 1071.

    Subject to certain exclusions published in statutes, Department of Defense regulations or

    TRICARE policy, the Basic Program requires TRICARE to pay for all medically necessary and

    appropriate services and supplies required in the diagnosis and treatment of illness or injury. 32

    C.F.R. 199.4(a)(1).

    20. Medical necessity is defined in 32 C.F.R. 199.2(b) as [t]he frequency, extent,

    and types of medical services or supplies which represent appropriate medical care and that are

    generally accepted by qualified professionals to be reasonable and adequate for the diagnosis and

    treatment of illness, injury, pregnancy, and mental disorders or that are reasonable and adequate

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    for well-baby care. The determination of whether the services are reasonable and necessary

    should be made in concert with a physician, who has determined that the services at issue are

    reasonable and necessary.

    21. Appropriate medical care is defined in 32 C.F.R. 199.2(b) as:

    (i) Services performed in connection with the diagnosis or treatment of disease orinjury, pregnancy, mental disorder, or well-baby care which are in keeping with

    the generally accepted norms for medical practice in the United States;

    (ii) The authorized individual professional provider rendering the medical care is

    qualified to perform such medical services by reason of his or her training and

    education and is licensed or certified by the state where the service is rendered orappropriate national organization or otherwise meets CHAMPUS standards; and

    (iii) The services are furnished economically. For purposes of this part,

    "economically" means that the services are furnished in the least expensive levelof care or medical environment adequate to provide the required medical care

    regardless of whether or not that level of care is covered by CHAMPUS.

    22. The Tricare Policy Manual states that the Department of Defense may provide

    any rehabilitative therapy to improve, restore, or maintain function, or to minimize or prevent

    deterioration of function, of a patient when prescribed by a physician. Tricare Policy Manual

    6010.54-M, August 1, 2002, Chapter 7, Section 18.1, Rehabilitation. The Policy Manual also

    provides that Physical therapy to improve, restore, or maintain functions, or to minimize or

    prevent deterioration of function of a patient when prescribed by a physician is covered in

    accordance with the rehabilitative therapy provisions found in Chapter 7, Section 18.1. Tricare

    Policy Manual 6010.54-M, August 1, 2002, Chapter 7, Section 18.2, Physical Medicine/Therapy.

    23. TMA does not have authority to contravene these published Department of

    Defense regulations or TRICARE policies.

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    27. Kaitlyns physical therapist uses horses as a physical therapy tool because

    effective therapeutic movements can be performed while a patient is on horseback. In 2006,

    Kaitlyns physical therapist placed her on a horse while volunteers secured her legs and led the

    horse in a circle. Instead of sitting on a ball or bench during the therapy session, Kaitlyn sits on a

    horses back. Her physical therapy goals include increasing flexibility of the joints, normalizing

    muscle tone, improving coordination of movements, improving symmetry and sensory-motor

    integration, helping with rightingand equilibrium reactions, maintaining strength and flexibility

    in her hips, enhancing body awareness, and strengthening muscles.

    28.

    The horse serves as a dynamic surface; its movements engaged Kaitlyns back

    and trunk muscles and allowed her to remain engaged for the entire 45-minute therapy session

    twice per week. The horses body heat serves to loosen her tight muscles and limbs, allowing her

    to stretch more effectively than when using a cold, static tool.

    29. Physical therapy activities include riding the horse backwards to improve balance

    and strengthen core muscles, having Kaitlyn lift herself from a horizontal position on the horses

    back with her legs remaining static, and other strength building activities that would be

    impossible for Kaitlyn to perform on a static tool such as a ball or a bench. The physical

    therapists reason for using the horse as a tool is simple: the horse is the only tool that works for

    Kaitlyn.

    30. The physical therapy Kaitlyn receives on the horse at her parents expense is

    based on the same principles and has the same objective as physical therapy using any other

    toolstretching and strengthening her muscles. The difference with the horse is that Kaitlyn is

    engaged and reaps the benefits provided by physical therapy for someone with her impairments.

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    31. Kaitlyns physical therapist is trained in physical therapy and is a licensed

    physical therapist. She does not become a hippotherapist simply by using a horse as a tool for a

    unique patient, no more than she becomes a physioball therapist when using a physioball as a

    tool. On the occasion that Kaitlyns physical therapist has received a prescription for

    hippotherapy, she has returned it to the physician because she is a physical therapist.

    32. Kaitlyns physical therapist utilizes a horse because it is the only physical therapy

    tool proved effective for treating Kaitlyns scoliosis. TRICARE covered these physical therapy

    sessions from 2006 until 2009, and Kaitlyns physical therapist continues to utilize a horse for

    Kaitlyns therapy.

    ALJFINDS THAT TMAMISTAKES PHYSICAL THERAPY FOR HIPPOTHERAPY

    33. Around June 2010, TMA informed Captain and Jennifer Samuels that Kaitlyns

    physical therapy claims from April 23, 2009, through March 31, 2010, were denied because the

    service was not a covered benefit under TMA policy. TMAs position was that Kaitlyn was not

    receiving physical therapy, but was instead receiving an unproven treatment known as

    hippotherapy.

    34. Often used an as umbrella term, the term hippotherapy is a misnomer, describing

    various therapy treatments, such as psychotherapy using a horse.6

    35. When TMA denied the care based on this reason, the family and her doctors

    believed this was a mistake that would be rectified once TMA learned that Kaitlyn was in fact

    receiving physical therapy using a horse as a tool.

    6During the ALJ hearing, Kaitlyn presented evidence from the American Physical Therapy Association

    acknowledging confusion in the misapplication of the term hippotherapy in the physical therapy context andproviding clarification of these terms to avoid confusion. SeeAppendix A. In its Final Decision, TMA persists in

    this misnomer, stating that hippotherapy is a form of exercise or therapeutic horseback riding. As the ALJ found,

    Kaitlyn does not us a horse for mere exercise or therapeutic riding, which is a legally operative term inapplicable to

    the physical therapy Kaitlyn receives. SeeAppendix C.

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    36. The Samuelss appealed TMAs decision to an administrative law judge who

    conducted a full evidentiary hearing.

    37. On February 10, 2012, approximately eighteen months after TMA first denied

    Kaitlyn cost-sharing for her physical therapy and after various levels of administrative appeals,

    TMA conducted a full evidentiary hearing on Kaitlyns case. Kaitlyns family hired an attorney

    who presented evidence and offered witnesses. TMA had an opportunity to cross-examine

    Kaitlyns witnesses and proffer its own evidence and witnesses. Both sides had an opportunity

    for opening and closing statements. Jennifer Samuels testified that Kaitlyns condition improved

    dramatically when using a horse as a tool in physical therapy. Conversely, her condition

    deteriorated during the months after TMAs cost-sharing denial before Kaitlyns family resumed

    treatment at their own expense.

    38. Kaitlyns doctor, who proscribed the physical therapy, testified that the horse is

    used as a tool in physical therapy, not simply for exercise or hippotherapy. Kaitlyns physical

    therapist testified that the medical coding she uses is coded to physical therapy. Kaitlyns

    physical therapist also noted that after TMAs initial denial of treatment, during the lapse in

    which Kaitlyn went without physical therapy, her spine curved significantly and rapidly from 31

    degrees to 40 degrees, and that after therapy balls and benches proved useless, the family

    resumed using a horse as a tool and began paying out of pocket for the sessions.

    39. There is no added cost to the government to utilize a horse as a physical therapy

    tool as opposed to any other physical therapy tool.Kaitlyns physical therapist also testified, and

    the ALJ acknowledges in his decision, that the cost of using a horse is less expensive to the

    government than using a ball or bench.

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    40. After listening to both parties present their evidence, the judge concluded that

    Kaitlyns therapy is physical therapy and as such is a covered benefit despite whether a horse

    was used as a tool by the physical therapist. The judge rejected TMAs conflation of the term

    hippotherapy, which would preclude using a horse as a tool in physical therapy, and

    determined that Kaitlyns physical therapy utilizing a horse is covered by the regulations.

    TMAREFUSES COVERAGE DESPITE ALJS FINDING

    41. Despite the ALJs findings, the TMA Director issued a Final Decision dated

    October 24, 2012, to the Samuels family declaring that Kaitlyns treatment is hippotherapy and

    not physical therapy, and because hippotherapy is not an approved treatment strategy, it was

    denying Kaitlyns claims for benefits.

    42. TMAs decision is devoid of reason and is unsupported by substantial evidence.

    TMA provides no legal or factual basis for its decision that physical therapy that utilizes a horse

    instead of a therapy ball, barrel, wedge or other tool is anything but physical therapy. TMA cites

    no source for its decision to deny care based on the tool selected because nothing in TMAs

    regulation permits the government to deny care based on which tool a doctor or physical

    therapist chooses. In its denial letter, TMA insists that Kaitlyn is not using the horse for physical

    therapy, despite the evidence furnished at the prior hearing and the ALJs finding to the contrary.

    Consequently, TMAs decision is arbitrary and capricious and plainly insufficient under the

    requirements of the APA.

    CLAIM FOR RELIEF

    COUNT ONE: Violation of 5 U.S.C. Section 706(2)(A)

    TMAs ruling declaring physical therapy to be unproven and uncovered hippotherapy is

    arbitrary, capricious, and an abuse of discretion

    43. Plaintiffs incorporate by reference the allegations of the preceding paragraphs.

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    44. A reviewing court shall hold unlawful and set aside agency action, findings, and

    conclusions found to be arbitrary, capricious, and an abuse of discretion, or otherwise not in

    accordance with law. 5 U.S.C. 706(a)(A).

    45. The APA requires an agency to examine the relevant data and to articulate a

    reasoned explanation for its action, which includes at a minimum a rational connection between

    the facts found and the course of action taken.

    46. In its Final Decision, TMA focuses almost entirely on the merits of hippotherapy

    as a standalone treatment, separate from physical therapy. Notably, TMA never rebuts the

    position shared by the Samuels family and the administrative law judge that Kaitlyn receives

    physical therapy that utilizes a horse. TMA simply declares that Kaitlyns treatment is not

    physical therapy and denies her benefits.

    47. TMA fails to examine the evidence and articulate a satisfactory explanation for its

    decision. The explanation it offers is conclusory, unsupported, and manifestly insufficient.

    48. TMAs decision is arbitrary, capricious, an abuse of discretion, and otherwise not

    in accordance with law. Plaintiff is therefore entitled to relief under 5 U.S.C. 702 and

    706(2)(A).

    PRAYER FOR RELIEF

    WHEREFORE, Plaintiffs respectfully requests this Court order a speedy hearing of a declaratory

    judgment action pursuant to Fed. R. Civ. P. 57, enter judgment in its favor, and:

    1. Declare that TMAs Final Decision is unlawful and void;

    2. Vacate and set aside TMAs Final Decision;

    3. Order TMA to pay its share of the costs, past, present, and future, of all physician-

    prescribed physical therapy that Kaitlyn has received since TMA first unlawfully denied her

    benefits;

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    4. Permanently enjoin and restrain TMA from denying Kaitlyn and her parents

    benefits for her physician-prescribed physical therapy;

    5. Award Plaintiffs their costs of litigation, including reasonable attorneys fees,

    pursuant to 28 U.S.C. 2412; and

    6. Grant Plaintiff such other relief as the Court deems just and proper.

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    Dated: August 15, 2014 Respectfully submitted,

    /s/ Michelle ReedMichelle Reed

    TX Bar # 24041758

    [email protected] Tannis

    TX Bar # 24090429 (application pending)

    [email protected]

    AKIN GUMP STRAUSS HAUER & FELD LLP1700 Pacific Ave. Suite 4100

    Dallas, Texas 75201

    Marcella Burke

    TX Bar # 24080734

    [email protected] GUMP STRAUSS HAUER & FELD LLP

    1111 Louisiana St.

    Houston, Texas 77002

    Edmund G. LaCour Jr.,

    TX Bar #24085422 (application pending)

    [email protected] BOTTS L.L.P.

    910 Louisiana St.

    Houston, TX 77002Telephone: (713) 229-1234

    Fascimile: (713) 229-7805

    Attorneys for Plaintiff

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    APPENDIX A

    ALJ Hearing Transcript.

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    107263784 v1

    BEFORE THEUNITED STATES DEPARTMENT OF DEFENSE

    DEFENSE OFFICE OF HEARINGS AND APPEALSWASHINGTON HEARING OFFICE

    TRICARE MANAGEMENT HEARING

    -------------------------------------------------------x

    IN THE APPEAL OF BENEFICIARY:KAITLYN N. SAMUELS, DEPENDENTOF CAPT. MARK SAMUELS, USNTask No. 11-43

    -------------------------------------------------------x

    Case No.

    AH-101962

    Courtroom 1631Federal Building110 0 CommerceDallas, Texas

    Friday,February 10, 2012

    The above-entitled matter convened for hearing, pursuant to notice, at 10:00 a.m.

    BEFORE:

    HON. CLAUDE R. HEINYAdministrative Judge

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    107263784 v1

    APPEARANCES:

    On behalf of the Agency:

    MICHAEL R. BIBBO, ESQ.Chief Claims CollectionOffice of General Counsel16401 E. Centretech ParkwayAurora, Colorado 80011-9066(303) 676-3462

    On behalf of the Beneficiary:

    COLBY VOKEY, ESQ.CHAD BOND, ESQ.Fitzpatrick Hagood Smith & Uhl, LLPChateau Plaza, Suite

    140 2 515 McKinney AvenueDallas, Texas 75201(214) 237-0900

    Reporter: Barbara Wall

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    107263784 v1

    INDEX

    OPENING STATEMENT: PAGE:

    On behalf of the Government:

    Michael R. Bibbo ..................................................................... 29

    On behalf of the Applicant:Colby Vokey ............................................................................ 15

    WITNESS DIR CROSS REDIR RECROSS

    Jennifer Samuels 45 74 75 --

    Suzanne Sessums 79 119 128 134146 147

    147 148

    Fernando Acosta 153 176 -- --

    Mark Samuels 193 218 -- --

    Jennifer Samuels 229 -- -- --

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    107263784 v1

    EXHIBITS IDENTIFIED RECEIVED

    BENEFICIARYS

    A 90 90B 90 90C 90 90

    D 90 90E 152 152F 251 251G 252 252H 254 254I 254 254

    CLOSING ARGUMENTS: PAGE:

    On behalf of the Government:Michael R. Bibbo ..................................................................... 264

    On behalf of the Applicant:Colby Vokey ............................................................................ 258

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    P R O C E E D I N G S

    (Time noted: 10:05 a.m.)

    JUDGE HEINY: Good morning. Im Claude Heiny. Im an administrative judge for the

    Defense Office of Hearings and Appeals, and I have been detailed to conduct this TRICARE

    hearing. It is Task Number 11-43. Today is Friday, the 10th of February 2012. Everyone except

    Mr. Bibbo is in Dallas, Texas. Were in Courtroom 1632, 1100 Commerce Street in Dallas,

    Texas. Mr. Bibbo is at the TRICARE Management Activity at 16401 East Centretech Parkway

    in Aurora, Colorado. Everyone else is here.

    Lets start with the entrances of appearance. Mr. Vokey.

    MR. VOKEY: Good morning, Your Honor. My name is Colby Vokey. My Bar number

    is 24043391 here in the State of Texas, and Im here representing the Applicant, and I also have

    with me Mr. Chad Bond, also for the Applicant.

    JUDGE HEINY: And Mr. Bibbo, if you could introduce yourself on the record.

    MR. BIBBO: My name is Michael Bibbo. Im an attorney with TRICARE Management

    Activity and Im representing TRICARE Management Activity in this hearing.

    JUDGE HEINY: Thank you, Mr. Bibbo.

    Also in the courtroom, if we could introduce the other individuals with us today.

    MR. VOKEY: Yes, Your Honor. This morning we also have Captain Mark Samuels,

    United States Navy, and we have Ms. Jennifer Samuels and we have Kaitlyn Samuels.

    JUDGE HEINY: All right. Have that seat.

    MR. BIBBO: Thank you. JUDGE HEINY: On the 12th of January I sent out a letter

    setting the hearing in which four issues were set forth. Does either party at this point in time,

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    first off, agree that those are the issues that were here to talk about and are there any changes,

    additions or corrections to those issues?

    MR. VOKEY: Agreed, Your Honor.

    JUDGE HEINY: Mr. Bibbo?

    MR. BIBBO: I agree.

    JUDGE HEINY: Okay. So thats what were here today, and obviously, Im going to go

    over a little bit of background information. This material has been sent out a number of times in

    preparing but Im going to go over it just to have it on the record.

    First off, this hearing is not adversarial. My role is that as a finder of facts, and in that

    capacity I may consider as evidence any testimony, as it says, briefs or affidavits in lieu of

    testimony, or documentation presented by the appealing party and TRICARE.

    At the conclusion of the hearing I will take the matter under submission and as soon as

    possible Im going to prepare a recommended decision, and that recommended decision will be

    final upon adoption by TRICARE in the Office of Assistant Secretary of Defense Health Affairs.

    So in this case, I do not have the final word. Basically, I make a recommendation, TRICARE

    will carefully consider that decision, and then their make their own determination, agreeing,

    disagreeing or agreeing in part.

    First off, Captain Samuels, I want you to know that the date and time of this hearing has

    been set aside specifically for you in order to hear this matter. There has been a bit of time

    getting to this. I believe I was assigned this case in July. There were some problems trying to

    get the cases coordinated; I had a mistaken believe that I had to coordinate this with other cases

    in Texas and then later I was informed that no, that I could conduct this hearing stand-alone, and

    so we finally got to the point where we were able to do that. I know theres been a change of

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    attorneys and that additional time is necessary to become familiar with the material. The

    Government is concerned with this and would like to move this on as timely as possible.

    I believe that the 1st of March was when the decision was made. This is Exhibit 31 with

    the position, and I believe that the decisions in these cases were made back in March of last year,

    in July I was assigned the case, and since then weve been trying very hard. I realize that justice

    delayed is many times justice denied, so were going to try to move this along just as quickly as

    we can. But I want to make sure that everyone knows that you have as much time as you need to

    present your material.

    Im going to go down the checklist just to make sure that I have covered everything. As I

    said, this is Task Number 11-43. Those exhibits offered on behalf of the Beneficiary will be

    marked alphabetically. Should the Government have exhibits, were going to mark those

    numerically. Going down the checklist. The exhibits are not in yet. The transcript will be here

    in probably ten days to two weeks. Ill get a recommended decision out just as soon as we can;

    well try to move this up to the front of the line because of the delays that weve had.

    So Ive introduced myself, weve gone to the statements and we have the four issues to

    be addressed. This is, for the record, TRICARE Management Activity Hearing Number AH-

    101962. This is Kaitlyn N. Samuels, TRICARE Standard Beneficiary.

    In this case, as I stated earlier, Im a fact-finder. Im going to let the sides present their

    cases as they choose. Im going to try to keep my interruptions to a minimum, but certainly Im

    going to have questions. This is a very complex case, and Im going to ask questions at the

    appropriate time but Im going to let each side present their material as they desire.

    I have a procedural history, and in opening statements which will go to in just a minute,

    we will give you the opportunity to correct everything that I have said in my opening. My

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    understanding is that Kaitlyn was born September 7, 1996, suffering from cerebral palsy, that

    back in 2009, as part of the therapy, therapy was given at the Rocky Top Therapy Center,

    treatment was given in 2009 and 2010. My understanding is that there was then a denial of that

    in December of 2010. At tab 10 there was a request for a formal review of that denial, October

    15 of 2010 there was a request for a review of the denial. Part of it going on in that appeal, the

    argument was what was the difference between therapy being provided on a therapeutic ball or

    balance board and therapy being given on a horse, that being a dynamic surface. The decision

    was that hippotherapy being a non-covered benefit, hippo coming from the Greek meaning

    horse, horse therapy.

    Following that, there was a number of studies that were submitted, and those are all

    found in my file under tab 14. A number of the studies being made showing that hippotherapy

    improved muscle tone, balance and posture control in children. The problem with the studies

    being is that they were very small studies with just a couple of individuals being involved. And

    at tab 17 there was a denial stating insufficient scientific data and peer-reviewed medical

    literature to support the effectiveness of hippotherapy in treatment of patients.

    The issue, of course, first off, is it medically necessary, and second, is the treatment being

    given supported by reliable evidence. There was a review of the material, additional hearing

    information is found at tab 24. The Hayes Directory is part of paragraph 27, again, a number of

    studies being issued.

    And then it comes down to 31 and that was TRICAREs statement of position, and that

    brings us to today. TRICAREs position which well hear shortly, again for the record, being

    that the treatment is not proper, that the data provided so far was insufficient to prove that this

    was reliable evidence that this treatment is the appropriate treatment, and as such, TRICARE,

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    part of its duties, of course, being the guardians of the Governments Treasury, they pay for those

    medical procedures which are warranted, but by law they cannot pay procedures which are not

    warranted. And so in this case I believe there was a payment and then at some point in time

    TRICARE asked for the $700 in overpayment at tab 13 to be returned.

    So basically, were here today to determine whether the treatment provided to the

    Beneficiary is indeed hippotherapy or some other type of treatment not standard for the

    Beneficiarys condition, whether the treatment provided to the Beneficiary has been proven safe,

    effective and comparable to standard treatments for the Beneficiarys condition, and if not so

    proven may not be cost-shared, and whether hippotherapy is unproven within the meaning of

    TRICAREs regulations and policies.

    Thats a quick reading of what brings us here today and just a little bit on the background

    of the delay that occurred. I was assigned the case in July, we tried to set it, we ran into some

    difficulties, including the Government shutting down in September, preventing us from traveling

    during that period of time. Thereafter, I believe there was a change of attorneys because for a

    while we were working with Leslie Roberts, and then there reached a point when Ms. Roberts

    did no longer continue in this case, and then Mr. Vokey was appointed. There was an appropriate

    amount of time for Mr. Vokey to get ready for the presentation of the material, and then there

    came a point in time where other case prevented Mr. Vokey from devoting his attention to this.

    Those were very valid and just reasons for why we delayed this. We finally were able to set this

    for early February and were here today to hear this matter.

    Before we go to opening statements, are there any procedural matters or other questions

    or other matters that should be addressed. Mr. Bibbo?

    MR. BIBBO: No, sir, I dont believe so.

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    JUDGE HEINY: Mr. Vokey?

    MR. VOKEY: No, Your Honor.

    JUDGE HEINY: All right. In this case well start with the opening statements.

    Normally in many cases the Government goes first, but in this case since the Beneficiary is

    appealing this, it seems to make sense for Mr. Vokey to start with the opening statement and then

    Mr. Bibbo to make his opening statement.

    Mr. Bibbo, any objection to going second?

    MR. BIBBO: No, no objection to that, sir.

    JUDGE HEINY: Then weve reached the point of opening statements, and lets go to

    opening statements.

    OPENING STATEMENT ON BEHALF OF THE BENEFICIARY

    MR. VOKEY: Good morning, Your Honor.

    I was out to dinner with my wife a couple of nights ago and we were on our way back

    home, and theres really two ways to drive back home, I go down Coit Road, she goes down

    Preston Road. She decides to take Preston which I know decidedly is the slower route to go, and

    I make a comment: I always go Coit. She says something back to me, and I say, Thats fine, you

    can go whichever way you want. Now, the tone that I used I intended to actually mean: I dont

    care, thats fine, you can do what you want. She interpreted that to be some kind of sarcastic

    remark that was criticizing the way that she was driving, the route that she was driving, and she

    got very angry. And I could tell she got very angry and Im trying to explain to her no, you can

    go any way you want, and she would just get angrier and angrier.

    And it wasnt until the next day that I realized it was a matter of semantics, the particular

    words that I used changed everything that happened in the car on our drive home that night.

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    This case is also a matter of semantics, and here one of the key words thats used in a

    variety of different ways and often misused is the word hippotherapy. What we have is we have

    Kaitlyn Samuels who is in the back of the courtroom right now. And sir, I want to correct you,

    she does not have cerebral palsy; thats not the condition that she suffers from. Its agenesis of

    the corpus callosum and pachygyria, and its significant, its different because agenesis of the

    corpus callosum qualifies as a rare disease; its something that is very infrequently found in the

    United States.

    And in order to understand the treatment that Kaitlyn has been receiving and to figure out

    exactly what kind of treatment it is, is it hippotherapy, is it physical therapy, is it some kind of

    other therapy, youve got to know a little bit about Kaitlyn Samuels. Now, Kaitlyn is 15 years

    old and shes had this condition her entire life because she was born with it. Not sure if it was

    something that was genetics or it was just Mother Natures curse, but she was born with this very

    same condition and has been like this her entire life.

    Now, what is agenesis of the corpus callosum? Its a separation of the corpus callosum or

    the corpus callosum is missing and the pachygyria is the flattening of the gyria of the brain, so

    the brain is much smoother than it should be. And this has resulted in a lot of neurological,

    neuromuscular problems with Kaitlyn her whole life. She also has a number of other things that

    affect her as well, including seizure disorder.

    So what does that mean for Kaitlyn Samuels and for Mark and Jennifer Samuels? That

    means a complete alteration in whats happened in their life. Kaitlyn requires an extraordinary

    amount of effort, an extraordinary amount of money, and just constant attention. And I wanted

    to correct you, Your Honor, on the fact that this is not cerebral palsy and this is a different

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    condition because its absolutely crucial when we deal with the semantics and the term

    hippotherapy and what Kaitlyn actually has been going through.

    Mow, she has seen a slew of doctors in her lifetime, and most importantly for here, shes

    been seeing an orthopedic doctor and neurologist, and youre going to hear form the neurologist

    later this morning, Dr. Acosta -- Im sorry -- this afternoon, and hes going to describe Kaitlyns

    condition and give some of the science and some of the background of why this can occur and

    whats happening with her.

    Youre also going to hear from Kaitlyns physical therapist, not her hippotherapist, not

    some other kind of occupational therapist or something else, her physical therapist. And youre

    going to hear from both Captain Samuels and Jennifer Samuels, and youre going to hear a lot

    about Kaitlyn and Kaitlyns routine, what she does when she gets up every morning, her

    personality, and what she does when she goes to Rocky Top to get physical therapy.

    Now, Kaitlyn right now at 15 years old is at a kind of crucial time in her life. Once she

    hits about 20 years old, her physical abilities are going to be kind of maxed out, so this is an

    absolute crucial time in her life for physical therapy, it must be done now. She has skills right

    now, she has a certain quality of life. There is a chance that she at some point can be able to

    walk and stand on her own, to feed herself, and if any of those things are possible, if her quality

    of life has any chance or either maintaining what it is now or getting even a little bit better for the

    rest of her life, now is the time when she must receive physical therapy.

    So what can she do and what cant she do? Well, first of all, Kaitlyn, as youre going to

    hear from her parents, is a wonderful girl, a very social girl, loves to be around people. She has

    certain things that she loves: she loves to eat, she loves to watch movies, she has a brother and

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    sister, loves to be around them. Shes just a very happy girl, and aside from the ailments already

    mentioned, otherwise healthy.

    But her limitations is she cannot communicate, she cannot speak, so neither Mark or

    Jennifer can ask her whats wrong and get a response from Kaitlyn as to whats going on

    physically with her body. Her mental level is somewhere between infant-toddler-preschool.

    Shes been tested for that and youll hear about that, but most likely shes about a toddler level as

    far as her mental capacity.

    Now, is this important? Its absolutely critical because were dealing with when we give

    physical therapy to Kaitlyn theres a huge problem, because you have someone whos got the

    mental level of a toddler, maybe high infant, theres only certain ways, as you know, Your Honor,

    that you have to deal with someone whos a toddler, who can respond at that level.

    Now, we already know the agenesis of the corpus callosum and the pachygyria, some of

    the physical ailments she suffers from as a result of this is curvature of the spine. This is where

    the physical therapy comes in in the first place. The entire purpose of this physical therapy is to

    strengthen her body and to keep her spine straight, and as youll hear from the physical therapist,

    if left unattended her spine will curve more and more and if nothing else is done about it, it will

    keep curving until her organs will be crushed and shell die. So physical therapy is absolutely

    important in order to maintain her quality of life and keep the spine from curving so she can

    function as a human being.

    So she must have physical therapy. She must have physical therapy to strengthen her

    legs, to maintain strength and flexibility in her hips, her core muscles in her midsection, and to

    keep that spine straight. So how do we do that? She must receive physical therapy. And

    physical therapy is crucial in this case involving the legs, the hips, that whole mid-body area.

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    So how is it accomplished? There is a lot of different ways for people who meet the

    physical ailments to accomplish that. You can use therapy balls, Swiss therapy balls I think

    theyre often called, barrels, and what youre doing is you have to take that person and put them

    on that tool and manipulate their body so that the legs get stretched, that theres proper posture,

    that the spine is straight, and that all these important muscles work all in the midsection and in

    the legs.

    So when Jennifer and Mark found Rocky Top that does therapy with horses, they found

    something that was an incredible stroke of luck that they came across this. Its absolutely

    imperative that Kaitlyn receive this. Now, had she gone to other physical therapy and has she

    gone to it? Absolutely. But the problem is Kaitlyn does not respond to that physical therapy,

    and youre going to hear from Mark and Jennifer about that very same thing, that when you take

    Kaitlyn to say physical therapy at school or some other physical therapist and they try to do it in

    a clinical setting of sitting her on a ball or a barrel, this 15-year-old girl who has the mental

    capacity of a toddler will not respond, she will not cooperate. She knows its a clinical setting

    and shes resistant.

    However, when you put her on the horse, everything is different, and what teenage girl or

    little girl doesnt love being on a horse anyway. So magic happens when Kaitlyn Samuels gets

    on a horse. She cooperates, she loves it, she enjoys it, and while shes on that horse the physical

    therapist does all those things necessary to address her physical condition.

    So we have Kaitlyn who must have physical therapy or her condition will degenerate,

    possibly even death, and the physical therapy thats not on a horse, those in a clinical setting

    dont work because this girl who has got the mental level of a toddler, at best, does not

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    cooperate. So the only option we have here is physical therapy using a different tool, thats

    where the horse comes in. So the other tools do not work, the horse does.

    Now, the flap over all this is the fact that this is called hippotherapy and that

    hippotherapy is untested, its unproven, and Ive read these things put forth in the materials that

    TRICARE provided me, and a lot of it I agree with. Hippotherapy in a lot of ways is untested or

    theres not enough research to back up whether its proven effective for a lot of different reasons,

    and I agree with that wholeheartedly.

    But whats being confused here, the semantic problem that we have in this case is the use

    of the term hippotherapy, and the fact that, Your Honor, you made the mistake of saying this is

    cerebral palsy is actually pretty key here because hippotherapy, that term as its used, is used for

    cerebral palsy and a number of other different conditions.

    Now, the difference is hippotherapy, as they refer to it, is often used for cognitive

    rehabilitative problems, so someone whose brain isnt functioning right, that the neurons arent

    connecting, and we do have that problem with Kaitlyn. But the use of a horse in this

    hippotherapy is used to somehow make some kind of connection, neurological connection

    between the brain and the rest of the body and hoping that the brain somehow responds.

    Hippotherapy is kind of a broad term and it can encompass a lot of things. Often its

    mentioned in connection with physical therapy, occupational therapy, and speech therapy. This

    hippotherapy, as they call it, is often used for Wounded Warriors who have had traumatic brain

    injury and they put them on a horse hoping theres some kind of connection. And as youll hear

    from Suzanne, the physical therapist, it is used for speech therapy and there are some children

    who utter their first words on the back of a horse.

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    Now, those ways they use a horse, this hippotherapy would not be covered by TRICARE,

    and I absolutely agree 100 percent. Why? Because what were dealing with is some kind of

    cognitive rehabilitative procedure dealing with theres something wrong with the brain not

    working and were hoping putting them on a horse will make some kind of connection and right

    that wrong. And make no mistake about it, Your Honor, that is not what is happening with

    Kaitlyn Samuels.

    Kaitlyn Samuels is undergoing physical therapy, physical therapy because of the

    curvature of the spine and the way the muscles and the joints in her body are reacting. That is

    what were dealing with Kaitlyn Samuels and her physical therapy.

    The purpose of the physical therapy is to keep that spine straight, we dont want the

    organs crushed, and to enable her muscles to hopefully at some point that she can be able to

    stand and walk, maybe even on her own.

    At present she can stand and walk with assistance, she can drink from a cup, she cannot

    eat on her own yet because chewing is somewhat of a problem, but for quality of life and what

    she goes through every day and what her mother and father go through every day, the physical

    therapy is absolutely essential so that she can perform some of those certain basic functions that

    we take for granted every single day, things like sitting on the toilet and going to the bathroom,

    things like getting in and out of bed without needing some kind of mechanical lift device being

    purchased for her to put her in and out.

    And right now shes at the critical stage where she can go one way or the other. If she

    digresses, we could be dooming her to a life of almost in a jail cell. Right now shes got a certain

    standard of life, a certain quality of life that could be better, and theres a chance that it could

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    improve significantly, significantly maybe not in physical appearance but significantly in the

    quality of life for Kaitlyn and for Mark and Jennifer.

    So what were really dealing with her in this issue this morning is not whether that this is

    some kind of unproven device, whether hippotherapy is something that should be accepted by

    TRICARE, what were dealing with right here is what Kaitlyn Samuels was receiving, and that is

    physical therapy that just happens to be on the horse. That is the tool, that is the Swiss exercise

    ball or the barrel, but instead it is a horse. And why must it be a horse? Because the others dont

    work.

    And what were seeking here, theres a lot of terms getting thrown out and theres a lot of

    confusion and theres a lot of things going back and forth, but what we cant lose here is the

    notion of justice, and Kaitlyn Samuels must have that horse therapy, and Mark Samuels, as a

    captain in the United States Navy, has given years and sacrificed a great deal for his country, and

    so has Jennifer and their other two children for him to serve in this country.

    And part of the reason why we join the service, we join the service to serve our country,

    we have patriotic feelings, but when we join the service were also told: Hey, sign here because

    one of the things you get is great medical care. Now, thats certainly not going to be a sole

    reason why young men and women join the service but its certainly an important factor. Its an

    important factor on staying in and continuing to sacrifice for your country.

    So when Mark Samuels enters the Navy hes told: Boy, its great benefits and he can

    have better benefits. And he gets married and Jennifer hears the same thing. And then they have

    their first child, Kaitlyn, and now it hits them that, my Lord, medical care is going to take over

    our life. And theyre at a stage now where they have a little girl who must have physical therapy

    and its being denied by TRICARE.

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    If theres any justice in this world, Your Honor, youll see that this is not some

    experimental hippotherapy modality, this is simply a horse used as a tool to perform essential

    physical therapy for Kaitlyn Samuels.

    Thank you.

    JUDGE HEINY: Mr. Vokey, if you can do me a favor, that monitor on that table, can you

    move it one way or the other because I cant see Kaitlyn.

    MR. VOKEY: You bet, Your Honor.

    JUDGE HEINY: And if you could move that chair, because I cant see Kaitlyn with the

    chair in my way. If you could move that chair, thats great right where shes at, but I need to see

    her.

    Mr. Bibbo, opening statement.

    OPENING STATEMENT ON BEHALF OF THE AGENCY

    MR. BIBBO: Thank you, sir.

    Sir, you mentioned in the lead up to introduction that this was a complex case, and I

    respectfully disagree with that. In fact, this is really a simple case. And when you get into any

    type of medical literature, when you get into the condition of Kaitlyn Samuels, certainly there are

    a lot of complexities, but the issues are quite simple. TRICARE does not pay for unproven care

    and hippotherapy, which this is hippotherapy, is not proven under TRICARE regulations, and

    therefore, TRICARE cannot pay for this treatment.

    Its clear when you look at the authorities about hippotherapy that theres causes for

    optimism, and at the least, riding a horse is very beneficial for a child suffering from cerebral

    palsy or similar conditions, and any child who suffers from those conditions could experience

    that, you see the pictures, the videos, its very compelling, its very inspiring. And there really is

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    reason to believe that this therapy with a horse, hippotherapy works, and theres certainly a lot of

    anecdotal evidence and some limited promising studies, and I would wholly endorse somebody

    who had a child with this condition to seek out this type of treatment, and if I was in that

    position, I would certainly want my insurance to cover anything that I would think could help my

    child who was suffering from this type of disability.

    This is interesting and important stuff but its not relevant to this hearing and under

    TRICARE regulations which specifically we are conducting this hearing under 32 CFR 199.10,

    and TRICARE isnt insurance, its a statutory benefits plan thats administered by TRICARE

    Management Activity, TMA, and TMA has to administer the TRICARE benefit in accordance

    with federal law, federal regulations and the TRICARE policy, and the decision in this case has

    to be made under those authorities.

    To be covered under TRICARE, hippotherapy must be a treatment thats proven by

    reliable evidence, and reliable evidence is defined in 32 CFR 199.2(b) and on that point it really

    is not closed, its not proven. Now, before we get to why its not proven, I will raise Mr. Vokey

    argued that this is just physical therapy using a horse. Well, by definition, hippotherapy is

    physical therapy, occupational therapy, speech therapy using a horse, and whether youre going

    to call it a stand-alone modality, whether youre going to call it a treatment strategy, under

    TRICARE they must be proven. Its a treatment, a specific form of treatment, and it must be

    proven safe and effective to be reimbursable under TRICARE.

    How do we know that this is hippotherapy? Look at the TRICARE policy, Exhibit 17.

    Theres been plenty of reviews done about hippotherapy and all looking at the safety and efficacy

    of hippotherapy, and in fact, if you look at page 3 theres a definitive finding from the Medical

    Benefits Reimbursement Branch that hippotherapy is a stand-alone modality.

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    The provider in this case is Rocky Top. We can look at their website or what was on their

    website, and thats in Exhibit 29, they talk about we offer hippotherapy; hippotherapy is licensed

    physical therapists, occupational therapists and speech therapists using a horse under a doctors

    prescription. Subsequently they changed that, and now theyre offering themselves as offering

    physical therapy and using the horse as a tool, and we can kind of realize why they made that

    change.

    Lets look at the Hayes assessment at Exhibit 27. Basically, Hayes considers

    hippotherapy a physical therapy, occupational therapy and speech language pathology treatment

    strategy, and it reviews the safety and effectiveness of that strategy.

    To say that the animal is simply another physical therapy tool is really an absurd

    argument. Its not the same as a ball, exercise equipment. TRICARE has b beneficiaries in

    every country. People ride elephants in Thailand. If a bunch of physical therapists decided they

    wanted to put kids on elephants in Thailand, do you think that would be reimbursable? Could

    Seaworld hire physical therapists and bill TRICARE or other insurers for providing dolphins or

    orcas as a physical therapy tool? That would be completely unproven.

    And I dont say these things to belittle hippotherapy, but to make the point that adding an

    animal changes the treatment. Just like Mr. Vokey said, you put them on a horse and everything

    is different. Yes, everything is different, thats why were talking about hippotherapy.

    Now, I will concede and I will endorse that hippotherapy is far more advanced than a

    therapy with any other animal. Theres literature looking at hippotherapy and its safety and

    effectiveness, but unfortunately, its not proven under TRICAREs authority. So its helpful to

    review the authorities that were dealing with. Lets consider this hearing first. This hearing is

    bound by 10 USC, Chapter 55, its bound by TRICARE regulations which is 32 CFR Part 199,

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    and its bound by all the TRICARE policy, procedures, instructions and guidelines, and you can

    find the authority for that at 32 CFR 199.10(6), so were bound by all that in this hearing.

    So what does it say in TRICARE regulations, that TRICARE only pays for proven care.

    You can find that in 3 2 CFR 199.4(g) (15). In 199.4 (g) (15) (C) it defines when care is proven,

    and it says unless reliable evidence -- and thats an important term -- shows that any medical

    treatment or procedure has been the subject of well controlled studies of clinically meaningful

    end points which have determined, and for the purposes of hippotherapy, its safety and efficacy

    is whats important here, the issue here is the safety and efficacy of hippotherapy.

    Also, 199.4(g)(15)(D) additionally says that if reliable evidence shows that further

    studies or clinical trials or necessary to determine the safety and effectiveness, then its not

    proven. And the issue here is if you look at the literature, virtually every study or article calls for

    more research.

    So the consistent thing in both of those definitions is you need to have reliable evidence.

    So what is reliable evidence? Well, reliable evidence is defined that theres a hierarchy -- thats

    found at 32 CFR 199.2(b) -- and it requires things like well- controlled trials, technical

    assessments, published reports of national organizations, et cetera. Specifically, excluded are the

    personal professional opinions of providers or that a provider would use a certain technique on a

    beneficiary to uphold their result.

    You can make the argument that this standard is too strict, that TRICARE should pay for

    more cutting edge care, that TRICARE should do more for disabilities, especially in cases like

    this, and looking at hippotherapys literature, maybe theres some type of problem with the

    standard type of medical research in proving, in having the type of studies that could prove

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    hippotherapy. That may be true, but thats really not within the scope of what were addressing

    today.

    And Im not here to dispute on behalf of TMA that Rocky Top is a good place, that it

    helps people, some with cerebral palsy or other related disabilities, and also as Mr. Vokey

    referenced, the Wounded Warriors, but its simply not relevant to this forum. Were bound by the

    authorities that I previously stated, and while there may be other avenues to see change of

    TRICARE regulations and policies, this is not one of them. Theres only way for the beneficiary

    -- and when I use the beneficiary, I use just generally the beneficiary putting the case as

    represented by Mr. Vokey, if I want to refer to Kaitlyn Samuels specifically, Ill refer to her -- but

    the beneficiary can only show that hippotherapy is proven through reliable evidence. Theyre

    not going to offer any today. Theyre going to offer some personal professional opinions by

    providers and theyll be informative in the treatment give to the beneficiary, but really, it wont

    go to whether hippotherapy is proven.

    Kaitlyn Samuels parents will testify. Again, well be able to understand more about her

    condition and the treatment and how it may be helping her, and of course, we hope that it would,

    and I believe were going to see a video that shows the type of treatment that Kaitlyn Samuels is

    receiving and maybe how its helping her.

    We can leave this hearing all believing that hippotherapy is amazing and life-changing

    and has dramatic effects on Kaitlyn Samuels. Its compelling, its extremely important, of

    course, to Kaitlyn Samuels, to her family and really anyone who cares for people who suffer with

    these type of disabilities, but really its irrelevant to the issues presented at this hearing. That a

    treatment may work for one beneficiary really has no relation to whether it can be paid under

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    TRICARE, that a single physical therapist and neurologist believes it works is equally irrelevant

    to the issues that we face today.

    Now, sir, you mentioned that the Beneficiary previously presented some studies and

    TRICAREs MBRB, Medical Benefits Reimbursement Branch, reviewed all of those and one

    might think why would did the Beneficiary submit all these studies about hippotherapy if were

    not dealing with hippotherapy, but perhaps theres been a change in the strategy in how you want

    to approach kind of fitting this in somewhere where maybe TRICARE, you could make an

    argument they should pay for it.

    But really, when you look at those studies, TMA -- and those were reviewed at TMA with

    the Medical Benefits Reimbursement Branch, we reviewed every single study that the

    Beneficiary submitted and only one of those was consistent and reliable evidence and was

    previously considered by TMA and the Hayes technical assessment, and it showed promising

    results but the study had significant limitations. We look at what is reliable evidence, the Hayes

    study at Exhibit 27, page 5 -- Exhibit 27 is the Hayes study, at page 5 it states the need for further

    research, that its a potential but unproven benefit, and it sites the low to moderate quality of the

    evidence.

    And thats just where we are with hippotherapy and nothing that the Beneficiary is going

    to offer today is going to have any effect on whether hippotherapy is proven under TRICAREs

    authorities. There is really one simple truth here and its just a lack of reliable evidence under

    TRICARE establishing hippotherapy as a proven treatment, and sir, thats all you need to know

    to make your recommendation in this case.

    As you stated, the Beneficiary has the burden or proof in this case, the Beneficiary isnt

    going to offer any further reliable evidence, hasnt offered much to begin with, and really there

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    just isnt anything to overcome the presumption that TMAs determination about this treatment

    being hippotherapy and not being proven is correct.

    I dont blame the Beneficiary, her parents acting on her behalf seeking TRICARE to pay

    for this treatment that they believe is helping their daughter and may very well be doing so, but if

    they want that, theyre in the wrong forum right now. Congress can change the laws, they can

    make hippotherapy a TRICARE benefit, the Agency could change its regulations through

    rulemaking or adopt new policy, in this forum we have to accept those authorities as they are.

    So what were going to see today? I expect well see a lot of compelling, interesting

    testimony and information, and again, sir, as you said, there are complexities in this evidence that

    will come up, theres a lot of complex issues that may arise from what we hear today. Some of

    it, you know, whats societys obligations to the physically disabled, and especially, as Mr. Vokey

    argued, the disabled children of service members who give so much for their country and do that

    with the understanding that theyre going to get a significant medical benefit.

    On the individual level, you want to give a child anything that you think would help

    when they suffer from such a severe disability. On a macro level, you have to manage a benefit

    for millions of people and you also have to worry about long-term safety and effectiveness when

    you say okay, this treatment is a TRICARE benefit, and so there have to be standards for that,

    and that may not always make sense to a beneficiary or a sponsor when they look at it on an

    individual level. If theres a lack of research here on hippotherapy, maybe the military health

    system should be funding more, and maybe we are, there may be studies going on that were not

    even aware of.

    So whether TRICAREs laws, regulations and policies serve what sometimes are

    conflicting interests when you look at individual beneficiaries versus you have to manage a total

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    benefit for a large spectrum of people, whether TRICAREs authorities do that effectively, we

    can discuss that for hours, we could have a conference about it, we could discuss it for days, but

    really the issues before us today are quite simple: hippotherapy, using physical therapy on a

    horse is hippotherapy, is a specific treatment and one would assume it has to be performed under

    pretty strict guidelines and regulations, but under TRICARE, hippotherapy is not proven due to a

    lack of reliable evidence, and therefore, it is simply not eligible to be reimbursed by TRICARE,

    and that really is the simple truth.

    Thank you, sir.

    JUDGE HEINY: Thank you.

    Mr. Vokey, before we got to the first witness, do we need a short break?

    MR. VOKEY: No, sir, I dont. Maybe, sir, well take five minutes.

    MR. BIBBO: Whos the first witness?

    JUDGE HEINY: Whos going to be your first witness?

    MR. VOKEY: Jennifer Samuels.

    JUDGE HEINY: Jennifer Samuels will be, but were going to take a five-minute break

    before we do that.

    When will you do your video?

    MR. VOKEY: Sir, were going to have Jennifer Samuels go first, shes going to do some

    as a witness, well put her on again later, and then when Ms. Sessums comes on it will be during

    Ms. Sessums testimony, shell be the second witness.

    JUDGE HEINY: All right. Its 10:46, were going to be off the record for five minutes.

    (Whereupon, a brief recess was taken. )

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    JUDGE HEINY: Were back on the record. The time is now 10:55. All parties present

    at the break are again present. And Ms. Samuels, if you can have a seat at that table.

    In these proceedings I do not have the ability to swear witnesses but I do draw their

    attention to Title 18 of the United States Code, Section 1001. Simply put, thats a federal statute

    applying to these proceedings which makes it a crime to knowingly and willfully make a false

    statement to the Federal Government during the performance of its duties. Should one do so,

    they can be subject to a fine of up to $10,000 and up to five years in prison. And you understand

    this warning?

    JUDGE HEINY: Could you please state your name, spell your last name?

    THE WITNESS: Jennifer Samuels, S- A-M-U-E-L-S.

    JUDGE HEINY: And provide either a business or a home address.

    THE WITNESS: 9904 Eddleman Court, Keller, Texas 76244.

    JUDGE HEINY: And youre Kaitlyns mother?

    THE WITNESS: Im Kaitlyns mother.

    JUDGE HEINY: Your witness.

    MR. VOKEY: Thank you, Your Honor.

    Whereupon,

    JENNIFER SAMUELS having been first duly cautioned, was called as a witness herein

    and was examined and testified as follows:

    DIRECT EXAMINATION BY MR. VOKEY:

    Q Jennifer, lets start by finding out a little bit about who you are. Where do you

    come from?

    A I grew up in Pensacola, Florida.

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    Q And I want to get to a little bit about how you met Mark and how you got

    married. So grew up in Pensacola, Florida. Did you go to high school there?

    A Yes, high school and college.

    Q And where did you go to college?

    A University of West Florida.

    Q And Jennifer, what did you study there at the University of West Florida?

    A I received a bachelor of science in health education.

    Q Health education. What does a degree in health education mean?

    A Basically I worked in wellness programs, you could teach health in schools, just

    basic health and wellness.

    MR. BIBBO: Excuse me. Could I interrupt for a second? Im not getting the greatest

    audio. I dont know if we can somehow adjust the microphones.

    JUDGE HEINY: Bring that closer to you, see if that makes any difference.

    THE WITNESS: Is that better?

    JUDGE HEINY: Is that any better?

    MR. BIBBO: Thats better, yes. Thats good.

    JUDGE HEINY: Speak close, speak loud.

    BY MR. VOKEY:

    Q So what got you interested in why you wanted to be a health education major?

    A I was just interested in health in general, considered nursing at some point in my

    life, and I also was very much into exercise at the time, taught aerobics, was a personal trainer,

    worked at health clubs, and it just kind of fit with all of my interests. I had an interest in

    nutrition as well.

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    Q So after you graduated did you actually work in that field?

    A Yes.

    Q What did you do?

    A I directed an employee wellness program for St. Lukes Hospital in Jacksonville,

    Florida, and I also worked at and managed a health club at some point. We moved a lot, thanks

    to the Navy. I also directed a corporate wellness program for a large health club in Corpus

    Christi, Texas that dealt with the contracts with chemical companies, Citgo and such.

    Q Now, I may end up slowing you down a little bit because weve got to make sure

    that the court reporter picks up everything for the transcript.

    A Okay.

    Q So when did you meet Mark?

    A When I was working at St. Lukes Hospital in Jacksonville; he was there for the

    Navy in Jacksonville.

    Q And when was that?

    A 1991.

    Q So you met Mark, I guess you guys fell in love there. Was it love at first sight?

    A Maybe.

    Q Okay. So when did you first -- your life changed when you started following

    Mark around.

    A Right. I moved later that year up to Maine with him when he was transferred to

    Maine.

    Q Where is that, Brunswick?

    A Brunswick, Maine.

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    Q And when you were up in Brunswick, Maine, what did you do while you were

    there for work?

    A That is where I worked at the base fitness center, I also managed a womens

    fitness center and ran a wellness program there for them.

    Q And what about you and Mark, when were you married?

    A 1993 in Brunswick, Maine.

    Q So in 1993 in Brunswick, where did you go after Brunswick?

    A We went to Corpus Christi, Texas.

    Q And Mark was down there, what was he doing down in Corpus?

    A He was an instructor in the training program.

    Q And what did you do while you were there in Corpus?

    A Initially I worked at Corpus Christi Athletic Club, thats where I ran the corporate

    wellness program. I continued to do that. Kaitlyn was born in Corpus and after she was

    diagnosed -- I was going to work part- time but after she was diagnosed it got to be too much.

    Q And when was Kaitlyn born?

    A She was born in 1996, September 7, 1996 .

    Q I want to find out a little bit about Kaitlyn which is why I had you come up here.

    So she was born in September of 1996. When did you first notice that there was something

    wrong with Kaitlyn?

    A I was convinced when she was four months old that something was wrong, but

    nobody believed me, but I knew. She just wasnt reaching for toys and doing things like my

    friends babies were, but it was very subtle so the doctors just usually theres not something

    wrong so they go with that. When she was six months old thats when they started going okay,

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    maybe something is wrong, but again, they still did not think it was anything significant. We

    went to the eye doctor who said something is wrong but its not her eyes, and then we wound up

    in neurology.

    Q And what did you find out going to the neurologist?

    A The neurologist, after examining her, said that yes, something is going on but he

    did not think it was anything significant, he ordered an MRI and also genetic testing and was

    floored when he saw her MRI with the agenesis of the corpus callosum and pachygyria.

    Q And were going to have Dr. Acosta here to talk about that as well, but since Ive

    thrown that term out there, can you explain to Judge Heiny what exactly that is?

    A Shes missing the corpus callosum. The corpus callosum connects the two sides

    of the cerebrum, there are other connections, commissaries, so her brain does connect but in a

    less efficient, roundabout way. She also suffers from pachygyria which is a migrational disorder.

    Pacha just means wide and it just means the gyria of her brain is like theyre kind of spread out,

    theyre fewer than they should be and theyre larger than they should be.

    Her MRI is fairly rare. I do know other families with a child with agenesis of the corpus

    callosum, but her whole MRI is very rare, it was sent to a specialist, William Dobbins, who

    studies lissencephaly and this type of brain abnormality, and he said it was very rare. Her

    neurologist at Johns Hopkins, when we lived there, said it was very rare. So Ive never met

    anybody who has the same or even a similar MRI as Kaitlyn.

    Q So early on for Kaitlyn, I guess she wasnt developing like other children were,

    and how was that, how did you notice that?

    A Mostly it was that initially she was not reaching for things. At four months old

    typically a baby is reaching for everything. She was not reaching for anything, and it was

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    almost she was too good, she was too content. That was the initial issue. The doctors, what they

    picked up on was that her focus, visually she wasnt focusing on things a six-month-old should,

    and thats why they initially sent us to the ophthalmologist who said it wasnt her eyes, it was

    something going on in the central nervous system which is actually what I thought before I went

    to the eye doctor, but I had to take her there first.

    Q And this is just kind of relying on what I remember as a parent when my children

    were young, about somewhere around six months, six to eight months they start to crawl and

    they start to move around.

    A Right.

    Q Did that happen with Kaitlyn?

    A No. She didnt sit until she was about nine months. Of course, she was

    diagnosed at this point, she was diagnosed between at seven and eight months, but all of her

    developmental milestones were delayed, and the only reason she did many of them is because of

    therapy and me working with her every single day at home, even having friends come over to

    help me do exercises with her.

    Q So at what point did you really realize that this was a completely life- changing

    condition that Kaitlyn had that was going to alter not only her life but your life forever?

    A Initially, because of the rarity of her MRI, and also because there are people that

    have just agenesis of the corpus callosum and find out later in life when they hit their head or

    need an MRI, they find out oh, I dont have a corpus callosum, so there is a very wide range of

    abilities with just missing the corpus callosum, and because the pachygyria along with it was

    very rare, no one really knew exactly. So what the neurologist told us at that appointment was

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    that she could be delayed and stay delayed for the rest of her life, she could catch up, or she

    could be anywhere in the middle.

    I would say its been very gradual over time. She always makes progress, she continues

    to make progress but its at a very slow pace. Gradually over time I think we realized -- probably

    when she was a toddler I really realized that were not going to catch up, and its just more

    acceptance as time goes on.

    Q I kind of assume you probably spend more time with her probably than anyone

    else on this planet.

    A Yes.

    Q I want to find out a little bit about Kaitlyn and what kind of girl she is. How

    would you describe your daughter?

    A Shes very -- shes just a happy kid, shes generally very happy. We went through

    some periods in her life maybe where she was not as happy. She definitely shows frustration, I

    can tell when shes frustrated, but generally shes just happy, shes just happy to be around her

    family, shes happy to be around her friends at school, she just really enjoys people.

    Q She cant communicate, no oral communication skills.

    A No. She verbalizes but no words.

    Q So how do you know when shes frustrated?

    A By what she