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Berge v. United States

United States District Court, District of Columbia

June 5, 2013

KENNETH BERGE, et al., Plaintiffs,
v.
UNITED STATES OF AMERICA, et al., Defendants

Page 37

For KENNETH BERGE, Plaintiff: Thomas Winfried Mitchell, LEAD ATTORNEY, KLORES & ASSOCIATES, PC, Washington, DC; Brendan H. Frey, PRO HAC VICE, Brian M. Saxe, PRO HAC VICE, David M. Honigman, PRO HAC VICE, Gerard V. Mantese, PRO HAC VICE, MANTESE HONIGMAN ROSSMAN AND WILLIAMSON, P.C., Troy, MI; Bruce J. Klores, Washington, DC; John J. Conway, PRO HAC VICE, JOHN J. CONWAY, PC, Royal Oak, MI; Scott Michael Perry, Perry Charnoff PLLC, Arlington, VA.

For DAWN BERGE, on behalf of themselves and their minor child Z.B., as individuals and on behalf of all others similarly situated, Plaintiff: Brendan H. Frey, LEAD ATTORNEY, Brian M. Saxe, PRO HAC VICE, Gerard V. Mantese, PRO HAC VICE, MANTESE HONIGMAN ROSSMAN AND WILLIAMSON, P.C., Troy, MI; David M. Honigman, LEAD ATTORNEY, PRO HAC VICE, MANTESE HONIGMAN ROSSMAN AND WILLIAMSON, P.C., Troy, MI; Thomas Winfried Mitchell, LEAD ATTORNEY, KLORES & ASSOCIATES, PC, Washington, DC; Bruce J. Klores, Washington, DC; Scott Michael Perry, Perry Charnoff PLLC, Arlington, VA.

For UNITED STATES OF AMERICA, U.S. DEPARTMENT OF DEFENSE, TRICARE MANAGEMENT ACTIVITY, ROBERT M. GATES, jointly and severally, Defendants: Adam D. Kirschner, LEAD ATTORNEY, U.S. DEPARTMENT OF JUSTICE, Washington, DC.

OPINION

Page 38

MEMORANDUM OPINION

REGGIE B. WALTON, United States District Judge.

The named plaintiffs, Kenneth and Dawn Berge, bring this class action on behalf of themselves, their minor child Z.B., and all others similarly situated, against the defendants, the United States of America, the Department of Defense (" the Agency" ), TRICARE Management Activity, and Chuck Hagel, United States Secretary of Defense, [1] alleging that the defendants' denial of coverage for Applied Behavioral Analysis (" ABA" ) therapy under the TRICARE Basic Program is " arbitrary, capricious, and contrary to law and regulation" in violation of the Administrative Procedure Act (" APA" ), 5 U.S.C. § 706 (2006). See Plaintiffs' First Am[]ended Class Action Complaint (" Am. Compl." ) ¶ ¶ 166-72. On July 26, 2012, the Court granted the plaintiffs' motion for summary judgment and enjoined the defendants from further denying coverage of ABA therapy under the TRICARE Basic Program. Berge v. United States, 879 F.Supp.2d 98, 135-36 (D.D.C. 2012). The Court also granted final certification to the class preliminarily certified by the Court during an earlier hearing. Id. at 136 n.22. This case is now before the Court on the plaintiffs' Motion to Clarify Class Certification and Relief (" Pls.' Mot." ) and the defendants' Motion to Amend Judgment (" Defs.' Mot." ). [2] For the reasons set forth below, the Court will grant the defendants' motion and deny the plaintiffs' motion as moot.

I. BACKGROUND

This case arises from the Agency's determination that ABA therapy, a form of treatment for autism spectrum disorder (" autism" ), is not a covered benefit under the TRICARE Basic Program, see Am. Compl. ¶ ¶ 5, 10, a program " similar to private insurance," which provides financial assistance to active duty and retired members of the armed forces for " certain prescribed medical care," 32 C.F.R. § 199.4(a) (2012); 10 U.S.C. § 1086 (2006). [3] The Basic Program was created pursuant to 10 U.S.C. § 1079 (2006), which instructs the Secretary of Defense, in consultation with the Secretaries of each military branch, to " contract . . . for medical care for" active duty and retired members of the armed services " under such insurance, medical service, or health plans as he considers appropriate." § 1079(a). Section 1079 also contains several exclusions from coverage under the Basic Program, including " [a]ny service or supply which is not

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medically necessary or psychologically necessary to prevent, diagnose, or treat a mental or physical illness, injury, or bodily malfunction." § 1079(a)(13). Pursuant to § 1079, the Agency promulgated regulations defining " medically necessary" services as those that are " [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." 32 C.F.R. § 199.2(b). " Appropriate medical care" is defined, in pertinent part, as " [s]ervices performed in connection with the diagnosis or treatment of . . . [a] mental disorder, . . . which are in keeping with the generally accepted norms for medical practice in the United States." Id. In order to qualify as " medical," a service must " pertain[] to the diagnosis and treatment of illness, injury, pregnancy, and mental disorders by trained and licensed or certified health professionals." Id.

Coverage of " [u]nproven drugs, devices, and medical treatments or procedures . . . the safety and efficacy of which ha[s] not been established" is also excluded from the Basic Program. Id. § 199.4(g)(15). A " medical treatment or procedure" is considered " unproven" " [u]nless reliable evidence shows that any medical treatment or procedure has been the subject of well-controlled studies of clinically meaningful endpoints, which have determined its . . . safety, and its efficacy as compared with standard means of treatment or diagnosis" or " [i]f reliable evidence shows that the consensus among experts regarding the medical treatment or procedure is that further studies or clinical trials are necessary to determine its . . . safety, or its effectiveness as compared with the standard means of treatment or diagnosis." Id. § 199.4(g)(15)(i)(C)-(D).

While not covered under TRICARE's Basic Program, ABA therapy has been covered under the Extended Care Health Option (" ECHO" ) Program, Am. Compl. ¶ 22, a " supplemental program to the TRICARE Basic Program," 32 C.F.R. § 199.5(a), that provides benefits " to assist in the reduction of the disabling effects of a qualifying condition of an eligible dependent" of a member of the armed forces on active duty for more than thirty days, 10 U.S.C. § 1079(d)(1), (3). In addition to a number of enumerated services such as home health care, rehabilitative services, and respite care, Congress authorized the Agency to cover " [s]uch other services and supplies as determined appropriate" irrespective of whether they are " medically or psychologically necessary." Id. § 1079(e)(1)-(7). However, coverage of " [d]rugs, devices, medical treatments, diagnostic, and therapeutic procedures for which the safety and efficacy have not been established" is excluded, and the listed services are subject to the same " unproven" standard governing the provision of medical care under the Basic Program. 32 C.F.R. § 199.5(d)(12). The Agency has previously covered ABA therapy under the ECHO Program as " special education" pursuant to § 1079(e)(3), Administrative Record (" A.R." ) at 36, which permits coverage for " [t]raining, rehabilitation, special education, and assistive technology devices," 10 U.S.C. § 1079(e)(3).

The Agency advanced two reasons for its decision that ABA therapy could not be covered under the Basic Program. See A.R. at 9-10. First, the Agency found that coverage was prohibited because " ABA is not medically or psychologically necessary and appropriate medical care for [autism] and that the reliable evidence reviewed indicates that ABA is an educational intervention and does not meet the TRICARE definition of medical care."

Page 40

A.R. at 10. The Agency then determined that, even if ABA could be considered medical care, coverage was nonetheless prohibited because " there is insufficient reliable evidence to find that ABA is proven as medically or psychologically necessary and appropriate medical care for [autism] in accordance with the requirements of 32 C.F.R. § 199.4(g)(15)." Id. Having determined that ABA therapy could not be covered under the Basic Program, the Agency found, however, that its assessment supported coverage of ABA therapy " as a non-medical service . . . to minimize the effects of [autism]" under the ECHO Program. A.R. at 36.

On July 26, 2012, this Court granted summary judgment to the plaintiffs, finding that the Agency's denial of coverage for ABA therapy under the Basic Program was arbitrary and capricious. Berge, 879 F.Supp.2d at 136. The Court found fault with the Agency's first rationale for concluding that ABA therapy could not be covered under the Basic Program, which was based on the Agency's consideration of " reliable evidence" in its determination that ABA therapy is not a " medically or psychologically necessary" treatment or " appropriate medical care" for autism, because the Agency's regulations do not require that " reliable evidence" support its determination of whether a service meets these definitions, and therefore, " the Agency's decision was not based on consideration of the 'relevant factors.'" Id. at 118 (citation omitted). Moreover, the Court held that even if the Agency could show that it had considered the relevant factors in reaching its decision, it failed to satisfactorily articulate how its conclusion that the educational components of ABA therapy foreclosed consideration of ABA as a medical treatment was rationally related to the evidence before it in light of the statute's purpose, which 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." Id. at 118-19, 124 (citation omitted).

With respect to the Agency's second rationale, the Court found that the Agency's determination that ABA therapy is " unproven" under § 199.4(g)(15) was arbitrary and capricious because it " failed to provide information on why certain materials were excluded as not reliable," particularly the materials submitted by the plaintiffs, and thus " the Court [was] unable to reasonably . . . discern the [A]gency's path" in reaching its decision. Id. at 127-28. The Court further held that there was " no apparent justification" for the Agency's decision to deny coverage under the Basic Program under the rationale that it was unproven while simultaneously providing coverage for it under the ECHO Program, because both programs are " governed by the same limitation as the Basic Program that precludes coverage for unproven '[d]rugs, devices, medical treatments, diagnostic and therapeutic procedures,'" id. at 130-31 (quoting ยง 199.5(d)(12)), and therefore, the Agency had implicitly determined that ABA therapy is a proven treatment, id. at 130-32. Finally, the Court held that the Agency failed to give due consideration to the purpose for which the statute was enacted, id. at 132-34, and to meaningfully consider its own regulations mandating comparison of a treatment under consideration with " the standard means of ...


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