Berge v. United States, Civil Action No. 10–0373 (RBW).

• Court: United States District Courts. United States District Court (Columbia)
• Writing for the Court: REGGIE B. WALTON
• Citation: 879 F.Supp.2d 98
• Parties: Kenneth BERGE, et al., Plaintiffs, v. UNITED STATES of America, et al., Defendants.
• Decision Date: 26 July 2012
• Docket Number: Civil Action No. 10–0373 (RBW).

879 F.Supp.2d 98

Kenneth BERGE, et al., Plaintiffs,
v.
UNITED STATES of America, et al., Defendants.

Civil Action No. 10–0373 (RBW).

United States District Court,
District of Columbia.

July 26, 2012.

[879 F.Supp.2d 99]

Brendan H. Frey, Brian M. Saxe, David M. Honigman, Gerard V. Mantese, Mantese Honigman Rossman and Williamson, P.C., Troy, MI, John J. Conway, John J. Conway, PC, Royal Oak, MI, Thomas Winfried Mitchell, Scott Michael Perry, Klores Perry Mitchell, PC, Bruce J. Klores, Washington, DC, for Plaintiffs.

Adam D. Kirschner, U.S. Department of Justice, Washington, DC, for Defendants.

MEMORANDUM OPINION
REGGIE B. WALTON, District Judge.

The named plaintiffs, Kenneth Berge and Dawn Berge, on behalf of themselves and all other individuals similarly situated,¹ filed Plaintiffs' First Amdended [sic]

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Class Action Complaint (“Am. Compl.”) on December 13, 2010, against the following defendants: the United States of America, the United States Department of Defense (the “DoD” or “Agency”), the TRICARE Management Activity (the “TMA”),² and Robert M. Gates, then United States Secretary of Defense.³ The First Amdended [sic] Complaint, brought under the Administrative Procedure Act (“APA”), 5 U.S.C. § 702 (2006), challenges the TMA's position “that ABA [Applied Behavioral Analysis] therapy is a covered benefit only under [a supplemental program for active duty members] and is not a covered benefit pursuant to the TRICARE Basic health benefits program,” which covers both active duty and retired members of the United States Armed Services. Am. Compl. ¶ 168; 10 U.S.C. § 1086; see also Defendants' Memorandum in Support of Their Cross–Motion For Summary Judgment and In Opposition to Plaintiffs' Motion for Summary Judgment (“Defs.' Mem.”) at 1. This case is now before the Court on the parties' cross-motions for summary judgment. See Plaintiffs' Renewed Motion for Summary Judgment (“Pls.' Renewed Mot.”); Defendants' Motion for Summary Judgment (“Defs.' Mot.”).⁴ For the following reasons, the Court will grant the plaintiffs' motion for summary judgment and deny the defendants' cross-motion for summary judgment.

I. Background A. The Class Plaintiffs

The class plaintiffs are active duty and retired uniformed service members of the United States Armed Services and their dependent children who have been diagnosed with some form of autism, and who, at some point, have had payment reimbursement requests refused for the ABA intervention provided to these children.⁵ Am. Compl. ¶¶ 1–11. As beneficiaries of the DoD's health care system (“TRICARE,” id. ¶ 40, also known as “CHAMPUS,” id. ¶ 96), ⁶ the plaintiffs assert that “TRICARE wrongfully refuses to provide

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coverage pursuant to the TRICARE Basic [P]rogram for ABA therapy,” id. ¶ 41.

B. Statutory and Regulatory Framework

Congress enacted Section 1079 of Title 10 of the United States Code in order to “assure that medical care is available for dependents ... of members [and “former members”] of the uniformed services.” 10 U.S.C. § 1079 (2006). The statute instructs the Secretary of Defense, “after consulting with other administering [Agency] Secretaries,” to contract “for medical care for those persons under such insurance, medical service, or health plans as he considers appropriate.” Id. In accordance with this mandate, the DoD adopted a regulation to implement the statute. See generally 32 C.F.R. § 199 (2011).

The TRICARE Basic Program, which, as noted earlier, is a health benefits program for current and retired members of the United States Armed Services, “is similar to private insurance programs, and is designed to provide financial assistance to ... beneficiaries for certain prescribed medical care obtained from civilian sources.” Id. § 199.4(a). In addition to paying for medical services for active and retired military members, the Basic Program also provides coverage for the members' dependents, including spouses, id. § 199.3(b)(2)(i), and children, id. § 199.3(b)(2)(ii). The TMA is the component of the DoD that administers the Basic Program.⁷ Defs.' Mem. at 4.

Under the Basic Program, the term “medical” refers “to the diagnosis and treatment of illness, injury, pregnancy, and mental disorders by trained and licensed or certified health professionals.” 32 C.F.R. § 199.2(b). The Basic Program defines “mental disorder” as “a nervous or mental condition that involves a clinically significant behavioral or psychological syndrome or pattern that is associated with a painful symptom, such as distress, and that impairs a patient's ability to function in one or more major life activities.” Id.

Central to this case is the limitation imposed under the Basic Program authorizing payment for only “medically or psychologically necessary” treatments. See id.§§ 199.4(a)(1)(i), 199.4(g)(1). “Medically or psychologically necessary” is defined by the TRICARE regulation 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.” Id. § 199.2(b).

For services to qualify as “[a]ppropriate medical care,” they must satisfy the following requirements:

(i) Services 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;

(ii) The authorized individual professional provider rendering the medical care is qualified to perform such medical services ... and[;]

(iii) The services are furnished economically.

Id.

In addition to requiring that covered treatments be medically or psychologically necessary, the Basic Program expressly excludes coverage for certain forms of medical treatments and procedures. Specifically,

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the TRICARE regulation provides that “[a]ny drug, device, or medical treatment or procedure, the safety and efficacy of which have not been established, ... is unprove[n] and cannot be cost-shared by [the Basic Program].” Id.§ 199.4(g)(15). Under the Basic Program

(i) [a] drug, device, or medical treatment or procedure is unproven:

...

(C) Unless 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 maximum tolerated dose, its toxicity, its safety, and its efficacy as compared with standard means of treatment or diagnosis.

...

(D) If 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 maximum tolerated doses, its toxicity, its safety, or its effectiveness as compared with the standard means of treatment or diagnosis....

Id.§ 199.4(g)(15)(i). Under this standard, only “reliable evidence” can be considered in determining whether a medical treatment or procedure is unproven, and therefore excluded from Basic Program coverage. Id.

In compliance with this regulation, the TMA must determine whether a certain treatment or procedure satisfies the reliable evidence standard before deciding to approve or deny it. See id.§ 199.4(g)(15)(i)(C). The DoD regulation further provides that

the term reliable evidence means only:

(i) Well controlled studies of clinically meaningful endpoints, published in refereed medical literature.

(ii) Published formal technology assessments.

(iii) The published reports of national professional medical associations.

(iv) Published national medical policy organization positions; and

(v) The published reports of national expert opinion organizations.

Id. § 199.2(b). Moreover, “[t]he hierarchy of reliable evidence of proven medical effectiveness, established by [the above-listed categories], is the order of the relative weight to be given to any particular source.” Id. “Specifically not included in the meaning of reliable evidence are reports, articles, or statements by providers or groups of providers containing only abstracts, anecdotal evidence or personal professional opinions.” Id. Finally, “the fact that a provider or a number of providers have elected to adopt a ... medical treatment or procedure as their personal treatment or procedure of choice” is not considered a reliable indicator of the effectiveness of a treatment. Id.

In addition to the Basic Program, the DoD administers the TRICARE Extended Care Health Option (“ECHO”) program, which “is essentially a supplemental program to the TRICARE Basic Program.” Id.§ 199.5(a)(1). The ECHO program “provide[s] an additional financial resource for an integrated set of services and supplies designed to assist in the reduction of the disabling effects of the ECHO-eligible dependent's qualifying condition.” Id.§ 199.5(a)(2). The ECHO program is limited to dependents of active duty personnel who have a qualifying condition. See10 U.S.C. § 1079(d)(3) (2006). Although the ECHO program does not require that the medical treatment be medically or psychologically necessary to be covered, see id. § 1079(e)(7) (granting the Secretary of Defense discretion to provide coverage under the ECHO program even if the treatment is not medically or psychologically necessary), it does exclude unproven drugs, devices,

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and medical treatments in the same manner as the Basic Program, see32 C.F.R. § 199.5(d)(12) (excluding from ECHO coverage unproven “[d]rugs, devices, medical treatments, diagnostic, and therapeutic procedures for which the safety and efficacy have not been established in accordance with [the relevant provisions of the Basic Program]”).

C. Factual and Procedural Background

Autism “is a complex developmental disability, which adversely affects, among other things, verbal and nonverbal communication and social interactions, a child's educational performance, and the overall ability...