Berge v. United StatesBerge v. United States
MEMORANDUM OPINION
The named plaintiffs, Kenneth Berge and Dawn Berge, on behalf of themselves and all other individuals similarly situated,
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.
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)®, and children, id. § 199.3(b)(2)(ii). The TMA is the component of the DoD that administers the Basic Program.
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)®, 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 “[appropriate 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;
(ü) 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. Spe
(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. See 10 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, de
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 of a person who suffers from the condition to function in society.” Pis.’ Mem. at 49; see also Administrative Record (“A.R.”), Volume (Vol.) Ill, Tab 8-2-13, (NIMH,
Although there is no cure for autism, ABA therapy has emerged as an intervention that can help children cope with the disorder. A.R., Vol. Ill, Tab 8-2-13 (NIMH: Development Disorders) at 491. ABA therapy is “a systemized process of collecting data on a child’s behaviors and using a variety of behavioral conditioning techniques to teach and reinforce desired behaviors while extinguishing harmful or undesired behaviors.” Pis.’ Mem. at 1; see also A.R., Vol. I, Tab 4 (Hayes Report Dated October 25, 2010 (“2010 Hayes Directory”)) at 55. “ABA therapy is an intensive, extremely detailed and enormously nuanced psychosocial, behavioral intervention ... [and] is, therefore, expensive.” Am. Compl. ¶ 32; see also A.R., Vol. I, Tab 4 (2010 Hayes Directory) at 55. “Effective ABA treatment requires 25-40 hours per week of services, usually over a period of years.” Am. Compl. ¶ 33; see also A.R., Vol. I, Tab 4 (2010 Hayes Directory) at 55.
The named plaintiffs of the class in this case are the parents of Z.B., “a minor child [who has been diagnosed] with autism.” Am. Compl. ¶ 40. “On April 11, 2007, ... [Z.B.’s pediatrician ... diagnosed [the then] two-year old ... with Autistic Disorder Infantile, Full Syndrome.” Plaintiffs’ Statement of Points and Authorities in Support of Motion for Class Certification (“Pis.’ Mem. to Certify”) at 10. The day after Z.B.’s diagnosis, his mother “contacted TRICARE’s Managed Care Support Contractor for the Southeast Region, Value Options” and was informed that because Z.B.’s father had retired from active service with the United States Air Force, Z.B. was eligible only to receive benefits under the Basic Program, and not the ECHO program. Id. at 11. Because Z.B. was ineligible for ECHO benefits, the family was infoxmed “that Z.B. [was] ineligible for benefits related to ABA sexvices.” Id. Thereafter, Z.B.’s parents continually
After careful reconsideration of this case, including all additional information, the second physician reviewer agrees with the Outpatient Psychiatric initial denial. Based upon the opinion expressed by the second physician reviewer, the initial denial is upheld.
This determination was based on:
The sponsor of the beneficiary in not on active duty. ABA therapy cannot be authorized unless the beneficiary is enrolled in the ECHO program. A requirement for participation in the ECHO program is that the sponsor be on active duty. In this case, the sponsor is retired and therefore the beneficiary is not eligible for the ECHO program. The requested ABA therapy services cannot be authorized.
Pis.’ Mem., Exhibit (“Ex.”) 11 (June 18, 2007 Z.B. Denial Letter) at 3.
On March 5, 2010, the plaintiffs filed this action in this Court under the APA, challenging the June 18, 2007 decision by the TMA denying coverage for Z.B.’s ABA therapy, which, as noted, was based on the conclusion that the plaintiffs did not qualify for ABA therapy reimbursement because they were not eligible to participate in the ECHO program. Defs.’ Mem. at 9. “On June 22, 2010[,] the [Agency] moved to dismiss [this action] for lack of a final agency action, or, in the alternative, moved to stay the proceedings until a final decision ... was issued.” Id. The Agency argued that the June 18, 2007 decision was not final because the TMA reopened the decision to consider whether ABA therapy is covered under the Basic Program. Id. (arguing that “[a]n initial determination for a claim for reimbursement under TRI-CARE is final unless ... the initial determination is reopened”) (internal quotation marks and citation omitted). Agreeing with the Agency that there had been no final agency action, the Court allowed the Agency additional time to review the plaintiffs’ request for benefits but declined to dismiss this case.
Ultimately, “[o]n October 29, 2010, the Chief of TRICARE Appeals issued a formal review decision denying reimbursement to [the] plaintiffs for ABA therapy under the TRICARE Basic Program for their dependent’s [autism].” Id. at 11. As a result of that decision, the Court ordered the plaintiffs to file an amended complaint challenging the October 29, 2010 decision. See Order, Nov. 19, 2010 (Dkt. # 71), at 1 (ordering the Agency to produce the complete administrative record and ordering the plaintiffs to file an amended complaint). On December 13, 2010, the plaintiffs filed their amended complaint, alleging that the “denial of coverage pursuant to the TRICARE Basic [P]rogram is arbitrary, capricious, and contrary to law and regulation.” Am. Compl. ¶ 169.
Following the defendants’ submission of the administrative record, the plaintiffs filed their motion for summary judgment on December 17, 2010. See generally Pis.’ Renewed Mot. In their motion, the plaintiffs argue that: (1) the DoD’s policy denying ABA therapy under the Basic Program is not entitled to deference under Chevron USA, Inc. v. Natural Resources Defense Council, Inc.,
In response, the Agency filed a cross-motion for summary judgment, along with a memorandum in opposition to the plaintiffs’ motion. See generally Defs.’ Mot. The Agency argues that: (1) under Chevron, the Court should accord deference to the DoD’s decision, Defs.’ Mem. at 14-15; (2) ABA therapy is an educational intervention rather than medical care under the Basic Program, id. at 30-31; (3) even if ABA therapy qualifies as medical care, it is not proven medical care under the Basic Program, id. at 34; and, therefore, the Court should conclude that the October 29, 2010 decision “was based upon a rational connection to the” administrative record, id. at 39.
II. Standard of Review
“Because this case involves a challenge to a final administrative action, the Court’s review is limited to the administrative record.” Muwekma Ohlone Tribe v. Kempthorne,
The APA entitles a person who has suffered “legal wrong because of agency action, or [who has been] adversely affected or aggrieved by agency action,” to judicial review. 5 U.S.C. § 702 (2006). Under the APA, a final agency decision must be set aside by a court if it is “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” Id. § 706(2)(A). “The arbitrary and capricious standard of the APA is a narrow standard of review.” Millican v. United States,
[A] court is not to substitute its judgment for that of the agency. Nevertheless, the agency must examine the relevant data and articulate a satisfactory explanation for its action including a rational connection between the facts found and the choice made. In reviewing that explanation, [a court] must consider whether the decision was based on a consideration of the relevant factors and whether there has been a clear error of judgment. Normally, an agency rule would be arbitrary and capricious if the agency has relied on factors which*106 Congress has not intended it to consider, entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or the product of agency expertise.
As the Supreme Court has made clear, when a court assesses an agency’s interpretation of “the statute which it administers,” it must apply Chevron’s two-step framework. Chevron,
III. Legal Analysis
A. Is Deference Owed to the Agency Decision (Chevron Step One)?
As an initial matter, the Court must address the plaintiffs’ arguments that the DoD’s decision to deny reimbursement for Z.B.’s ABA therapy is not entitled to Chevron deference. The plaintiffs make five arguments in support of this position: (1) The Agency’s policy of excluding ABA therapy from coverage under the military health benefits statute because it “is [not] medically or psychologically ' necessary, and appropriate medical care for [Autism Spectrum Disorder (“ASD”) ] that has been proven safe and effective in accordance with the reliable evidence standard as required by TRICARE regulations ...,” A.R., Vol. I, Tab 1 (Formal Review Decision) at 7 (footnotes omitted),
1. The Unambiguousness of the Military Health Benefits Statute
The plaintiffs first argue that the Agency’s policy is not entitled to deference because the governing statute is unambiguous. Id. at 7-8. They contend “[i]t is crystal clear that Congress did not intend to exclude (as ‘not medically or psychologically necessary’ and not ‘medical/health care’) a medically and psychologically necessary, intensive, and enormously effective therapy like ABA, which is designed, supervised, and performed by highly trained and skilled professionals.” Id. at 7. Based on their view that the statute is unambiguous, the plaintiffs reason that the Court has no choice but to “ ‘give effect to Congress’s unambiguously expressed intent’ ” that ABA therapy must be provided to the dependents of members of the armed forces. Id. (quoting Beverly Health & Rehab. Servs. v. Nat’l Labor Relations Bd.,
The Agency counters that “[t]he military health benefits statute does not unambiguously require ABA therapy to be covered under the TRICARE Basic Program,” Defs.’ Mem. at 14; rather, the Agency emphasizes that the statute states that
The plaintiffs reply that only after the Court “draw[s] on all of ‘the traditional tools of statutory construction,’ ” is it permitted to conclude that the statute is unambiguous. See Plaintiffs’ Reply Memorandum in Support of Their Renewed Motion for Summary Judgment and Memorandum in Opposition to Defendants’ Cross-Motion for Summary Judgment (“Pis.’ Reply”) at 12. Moreover, the plaintiffs note that “[c]ourts, in their Chevron [s]tep [o]ne analysis, do not interpret statutory phrases in isolation, because the meaning or ambiguity of certain words or phrases may only become evident when placed in context.” Id. (internal quotation marks and citation omitted). The plaintiffs insist that the Agency commits a fundamental error by simply assuming that it is entitled to Chew'on deference “without employing any of the traditional tools of statutory interpretation” or refuting any of the plaintiffs’ arguments based on those tools. Id. at 13 (internal quotation marks omitted). The plaintiffs further argue that because the Agency has never “provided an interpretation of its most fundamentally applicable regulations,” the Agency’s position that it is entitled to “substantial deference” because it is “interpreting its own regulations” is baseless. Id. at 2-3.
The Agency counters, arguing that it has interpreted the relevant regulation and notes that it did include an explanation for its conclusion that ABA therapy is not medically or psychologically necessary health care, or in the alternative, that it is “unproven” care, in its Formal Review Decision, which is supported by an administrative record totaling more than 3,000 pages. Defendants’ Reply to Plaintiffs’ Opposition to Defendants’ Motion for Summary Judgment (“Defs.’ Reply”) at 5-7.
The District of Columbia Circuit has consistently required that, absent an explicit delegation of authority to an agency, there must be an implicit delegation of authority to the agency for Chevron deference to be accorded by the Circuit to an agency interpretation. See, e.g., Sea-Land Serv., Inc. v. Dep’t of Transp.,
As noted above, the plaintiffs argue that the Agency’s position is not entitled to deference because the statute unambiguously requires coverage of ABA therapy under the Basic Program. Pis.’ Mem. at 8. The Agency counters that the military health benefits statute does not unambiguously mandate ABA therapy coverage under the TRICARE Basic Program; rather, the statute provides a general guarantee of coverage unless the care is not “medically or psychologically necessary.” Defs.’ Mem. at 14.
The relevant statutory text at issue is 10 U.S.C. § 1079(a), which states:
*110 To assure that medical care is available for dependents ... of members of the uniformed services ... the Secretary of Defense ... shall contract ... for medical care for those persons.... The types of health care authorized under this section shall be the same as those provided under section 1076 of this title,[11 ] except ... [a]ny service or supply which is not medically or psychologically necessary to prevent, diagnose, or treat a mental or physical illness, injury, or bodily malfunction....
See 10 U.S.C. § 1071 (“The purpose of this chapter 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.”) (emphasis added). Because the Agency is correct in stating that the statute does not explicitly mandate coverage for ABA therapy, but instead contains a general guarantee of health care-related coverage unless the care is “not medically or psychologically necessary,” see 10 U.S.C. § 1079(a), the question the Court must resolve is whether Congress intended to delegate authority to the Agency to interpret the phrase “not medically or psychologically necessary,” and thus allow it to determine which services fall under this exclusion. See National Mining Ass’n,
The Court must begin its inquiry by examining the plain language of the statute. See Am. Bankers Ass’n v. Nat’l Credit Union Admin.,
In National Mining Ass’n, the District of Columbia Circuit evaluated whether the
Here, to determine whether the terms— medically, psychologically, necessary, and medical — are ambiguous and subject to multiple definitions, the Court consults the same source considered by the Circuit in National Mining Ass’n: dictionaries.
In National Mining Ass’n, the “major source of ... ambiguity [was] the word ‘rights.’ ”
The word “medically” is a derivative of and has the same meaning as the word “medical.” Similar to the definition of the word “right” in National Mining Ass’n, “medical” and “necessary” both have multiple definitions and are thus subject to the same ambiguity, which is magnified when the words are interpreted together as a phrase. “Medical” can mean “relating to, or concerned with physicians or the practice of medicine” or “requiring or devoted to medical treatment,” Medical Definition, Merriam-Webster Online Dictionary, http://www.merriam-webster.com/ dietionary/medically, while “necessary” can
Moreover, when viewing the two terms collectively as a phrase, the determination of which forms of medical or psychological care are necessary is also subject to interpretation, particularly here, where Congress left each of the terms, and the phrase itself, undefined. In the absence of such definitions, this Court, like the Circuit in National Mining Ass’n,
With the adoption of the Dependents’ Medical Care Act statute, Congress created a military health care system to “provid[e] an improved and uniform program of medical and dental care for members of the uniformed services and their dependents.” Pub.L. No. 84-569, 70 Stat 250 (1956). The authority to implement this health care program was, moreover, delegated to the Secretary of Defense by Congress. See 10 U.S.C. § 1079(a) (“[T]he Secretary of Defense, after consulting with the other administering Secretaries, shall contract, under the authority of this section, for medical care for those persons under such insurance, medical service, or health plans as he considers appropriate.”); see also Ike Skelton National Defense Authorization Act for Fiscal Year 2011, Pub. L. No. 111-383, § 711,124 Stat. 4137, 4246 (2011) (“[T]he Secretary of Defense shall have responsibility for administering the TRICARE program and making any decision affecting such program.”). Because Congress specifically delegated authority to the DoD to implement and make decisions affecting the military’s health care program, this Court must take care to avoid infringing on the Agency’s authority. See Morion v. Ruiz,
In their Renewed Motion for Summary Judgment, the plaintiffs argue that the DoD’s interpretation of the types of services that are not medically or psychologically necessary is owed no deference by the Court because “[t]he statute here is unambiguous in light of its plain meaning, legislative history, its internal structure, the regulations promulgated under it, and the canons of construction.” Pis.’ Mem. at 7. Specifically, the plaintiffs posit that “[i]t is crystal clear that Congress did not intend to exclude ... a medically and psychologically necessary, intensive, and enormously effective therapy like ABA, which is designed, supervised, and performed by highly trained and skilled professionals.” Id. The plaintiffs note that the congres
In summary, with regard to Chevron step one, the Court concludes that the disputed language of the statute is ambiguous because it is subject to more than one definition. Moreover, the statutory language expressly delegates sole authority to the Agency to implement and make decisions with respect to the Basic Program. See 10 U.S.C. § 1079(a); see also § 711,
The Court, having determined “that statutory ambiguity has left the [A]gency with a range of possibilities and that the [A]gency’s interpretation falls within that range, ... the [A]gency ... ha[s] survived Chevron step one,” and the Court must now proceed to Chevron step two. Barrington,
1. Arbitrary and Capricious Analysis
At Chevron step two, the Court may not disturb an agency rule unless it is “arbitrary or capricious in substance, or manifestly contrary to the statute.” Household Credit Servs., Inc. v. Pfennig,
[njormally ... be arbitrary and capricious if the agency has relied on factors which Congress has not intended it to consider, entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or the product of agency expertise.
Motor Vehicle Mfrs. Ass’n of U.S.,
a. Did The Agency Rely On Relevant Factors, Or Did It Rely On Factors Its Regulations Did Not Intend To Be Considered, or Did It Fail To Consider An Important Aspect Of The Problem?
The Agency asserts that its “assessment that ABA [is] not ‘medically or psychologically necessary’ was based on a consideration of the relevant factors needed to make such a decision and was a rational decision given the record before it.” Defs.’ Mem. at 21-22. On the other hand, the plaintiffs assert the following:
In its October 2010 denial decision, [the] DoD simply concluded that ‘ABA is an educational intervention and does not meet the TRICARE definition of medical care,’ without actually exploring and applying the statutory and regulatory definitions of ‘medical’ and ‘health care.’ Instead of utilizing all of the language contained in the statutory and regulatory definitions for ‘medical’ and ‘health care,’ [the] DoD just sought out sources that used variations of three key words: ‘education,’ ‘teach,’ and ‘instruction.’ [The] DoD then declared, without any analysis, that ABA therapy is ‘educational,’ and, therefore, it cannot be ‘medical.’ ” At the outset, [the] DoD did acknowledge the broad and liberal definition of ‘medical’ — but then refused to apply it.
Pis.’ Mem. at 32-33.
As noted in Part III.A.1 of this opinion, supra at 19, 10 U.S.C. §' 1071 authorizes a “uniform programf, TRICARE, for] medical [benefits] ... for members and certain former members of [the Uniformed Services], and for their dependents.” Specifically, the “[TRICARE program] is authorized at Sections 1079, 1086, and 1091 [of Title 10] to contract with civilian providers for the health care program benefits authorized under Section 1077.” A.R., Vol. I, Tab 1 (Formal Review Decision) at 22.
Under the TRICARE statute, medical care is available to dependents under Section 1079(a), which provides:
To ensure that medical care is available for dependents, ... the Secretary of Defense, after consulting with the other administering Secretaries, shall contract, under the authority of this section, for medical care for those persons under such insurance, medical service, or*116 health plans as he considers appropriate. The types of health care authorized under this section shall be the same as those provided under section 1076.
10 U.S.C. § 1079(a). Section 1076 of the statute provides that the medical care to which a dependent is entitled shall be the same as that prescribed under Section 1077, which states:
(a) Only the following types of health care may be provided under section 1076 of this title:
(1) Hospitalization.
(2) Outpatient care.
(3) Drugs.
(4) Treatment of medical and surgical conditions.
(5) Treatment of nervous, mental, and chronic conditions.
(6) Treatment of contagious diseases.
(7) Physical examinations, including eye examinations, and immunizations.
(8) Maternity and infant care, including well-baby care that includes one screening of an infant for the level of lead in the blood of the infant.
(9) Diagnostic tests and services, including laboratory and X-ray examinations.
(10) Dental care.
(11) Ambulance service and home calls when medically necessary.
(12) Durable equipment, which may be provided on a loan basis.
(13) Primary and preventive health care services for women (as defined in section 1074d(b) of this title).
(14) Preventive health care screening for colon or prostate cancer, at the intervals and using the screening methods prescribed under section 1074d(a)(2) of this title.
(15) Prosthetic devices, as determined by the Secretary of Defense to be necessary because of significant conditions resulting from trauma, congenital anomalies, or disease.
(16) A hearing aid, but only for a dependent of a member of the uniformed services on active duty and only if the dependent has a profound hearing loss, as determined under standards prescribed in regulations by the Secretary of Defense in consultation with the administering Secretaries.
(17) 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.
10 U.S.C. § 1077(a)(l-17).
The plaintiffs assert that “[t]he treatment of autism by ABA therapy falls within at least three categories of ‘heath care’ or ‘mental health care’ that are provided as TRICARE Basic [P]rogram benefits” under the statute: “[t]he treatment of a ‘medical condition,’ pursuant to 10 U.S.C. 1077(a)(4); [t]he treatment of a ‘nervous, mental, and chronic condition,’ pursuant to 10 U.S.C. 1077(a)(5); and [a] ‘rehabilitative therapy’ to improve, restore, or maintain function, or to minimize or prevent deterioration of function, of the patient when prescribed by a physician,’ pursuant to 10 U.S.C. 1077(a)(17).” Pis.’ Mem. at 31. On the other hand, the Agency states that “[b]ased on the[ ] definition! ] and reliable evidence, [the] DoD concluded that ABA did not meet the definition of medical care, but rather found ABA to be an educational intervention aimed at modifying social behavior.” Defs.’ Mem. at 31. The plaintiffs maintain that despite the DoD’s exclusive reliance on the “reliable evidence standard” as the basis for assessing what coverage is available under the Basic Program, the regulatory definitions of “medically or psychologically necessary” are “only tangentially related” to the reliable evidence standard. Pis.’ Mem. at 43-
Pursuant to 32 C.F.R. §§ 199.2 and 199.4(g)(15), “[t]he TMA Deputy Director tasked the Chief [of the Medical Benefits and Reimbursement Branch (‘MB & RB’) ] to determine' whether ABA satisfies the ... criteria for medically or psychologically necessary treatment, and appropriate medical care.” A.R., Vol. I, Tab 1 (Formal Review Decision) at 9. The MB & RB Chief “concluded, in pertinent part, that: ... ABA is not medically or psychologically necessary and appropriate medical care for ASD and that the reliable evidence reviewed indicates that ABA is an educational intervention and does not meet the TRICARE ‘ definition of medical care.” Id. at 9-10. In conducting this assessment, the MB & RB Chief undertook “an in depth review' of the reliable evidence, such as medical literature and technology assessments, along with all documentation submitted by the Beneficiary.” Id. at 9. The assessment was then forwarded to the TMA Director, who concurred with the findings of the MB & RB Chief based on the evidence that had been reviewed and “a report by Hayes, Inc. (Hayes), a nationally recognized health technology assessment entity.” Id. at 10. Specifically, “the Director of TMA reached the conclusion that ABA is not ... covered under the Basic Program because it is (1) an ‘educational intervention’ rather than ‘medical’ care as contemplated by the [A]geney’s regulations, and, alternatively, (2) not ‘proven’ medical care even if considered to be medical care.” Defs.’ Mem. at 26-27.
The plaintiffs argue that the Agency’s explanation is insufficient because it fails to “meaningfully address[ ] its own regulations defining ‘medically or psychologically necessary’ or ‘medical,’ ” but instead, “focuses selectively on the ‘reliable evidence’ regulation.” Pis.’ Reply at 7. Moreover, as noted earlier, the plaintiffs opine that “the regulatory definitions of knedieally or psychologically necessary’ and ‘medical’ do not even rely on the ‘reliable evidence’ standard, but rather rely on common-sense notions of ‘general acceptance’ and ‘pertaining’ to a mental disorder.” Id.
As an initial matter, the Court agrees with the plaintiffs that the Agency has failed to meaningfully address its own regulations and instead has concentrated on factors that the regulations do not contemplate in its determination of whether ABA is “medically and psychologically necessary” “medical care.” The Basic Program covers “medically necessary services and supplies required in the diagnosis and treatment of illness or injury, including maternity care and well-baby care.” 32 C.F.R. § 199.4(a)(l)(i). Furthermore, the term “medical” is defined as
[t]he generally used term which pertains to the diagnosis and treatment of illness, injury, pregnancy, and mental disorders by trained and licensed or certified health professionals. For purposes of CHAMPUS, the term “medical” should be understood to include “medical, psychological, surgical, and obstetrical,” unless it is specifically stated that a more restrictive meaning is intended.
32 C.F.R. § 199.2(b). Finally, the term “medically or psychologically necessary” is defined as follows:
*118 The 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 for well-baby care.
Id. (emphasis added). The regulation’s definitions of “medical care” and “medically and psychologically necessary” make no reference to the reliable evidence standard. The reliable evidence standard only becomes a required consideration when the Agency is considering whether a treatment is proven or unproven. See id. § 199.4(g)(15) (stating, in relevant part, that “[a]ny drug, device, or medical treatment or procedure, the safety and efficacy of which have not been established, as described in this paragraph (g)(15), is unproved and cannot be cost-shared by CHAMPUS except as authorized under paragraph 199.4(e)(26) of this part. A ... medical treatment or procedure is unproven ... [u]nless reliable evidence shows that [it] 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”) (emphasis added). Consequently, because the Agency erroneously reviewed whether ABA therapy is medically or psychologically necessary medical care under the “reliable evidence” standard, which is not required by the regulation and is therefore inconsistent with it, see Thomas Jefferson Univ. v. Shalala,
b. Was the Agency’s Decision Rationally Related to the Choice Made Considering the Objectives of the Statute?
Alternatively, even if the Agency could demonstrate that it considered the relevant factors in reaching its determination that ABA therapy is not medically or psychologically necessary medical care, summary judgment in favor of the Agency would still be inappropriate because it has not articulated a satisfactory - explanation as to how its decision is “rationally related” to the choice it has made in light of the statute’s purpose, which is to “provid[e] an improved and uniform program of medical and dental care for members of the uniformed services and their dependents.” Dependents’ Medical Care Act, Pub.L. No. 84-569, 70 Stat. 250 (1956). Congress intended to achieve this objective by implementing a program that would “discharge a moral obligation to the uniformed services, and ... provide military personnel with medical benefits comparable to those extended to federal civilian employees.” Barnett v. Weinberger,
At the second step of the Chevron analysis, courts must assess whether the Agency has “examine[d] the relevant data and articulate[d] a satisfactory explanation for its action including a rational connection between the facts found and the choice made.” Motor Vehicle Mfrs. Ass’n of U.S.,
The Agency argues that its conclusion that “ABA is [n]ot [c]overed [u]nder the TRICARE Basic Program was [b]ased on a [r]ational [Connection to the [fjacts [b]e-fore [i]t.” Def.’s Mem. at 29. First, it represents that its determination that ABA is an educational intervention, as opposed to medical treatment, was based on consideration of its own regulation defining the terms “medical” and “medically and psychologically necessary,” id. at 30 (citing 32 C.F.R. § 199.2(b)), as well as a “comprehensive review” of the relevant medical literature, which it concluded “showed ABA’s function is to modify social behavior rather than treat the underlying illness of ASD,” id. at 32-34 (citing, A.R., Vol. I, Tab 1 (Formal Review Decision) at 25-30)¡ The plaintiffs seem to argue in response that the Agency has not shown how its definitional regulation is rationally connected to its determination that ABA is not medically or psychologically necessary, in light of the Agency’s failure to “explain how it ... conclude[d] that ABA therapy does not fit within this regulatory definition.” Pis.’ Reply at 3. Focusing on the regulation defining “medically and psychologically necessary,” the plaintiffs assert that the Agency “has never even endeavored to discuss what ‘general acceptance’ is or who ‘qualified professionals’ are, let alone whether ABA meets these very reachable standards.” Id. Turning to the Agency’s definition of “medical,” the plaintiffs contend that the Agency “needed to explain exactly how ABA therapy does not ‘pertain to the treatment of a mental disorder’ ” to rationally conclude that it is not medically necessary. Id. at 6. The plaintiffs also maintain that Congress did not intend to exclude ABA coverage from the Basic Program. Pis.’ Mem. at 30. Thus, the issue presented to the Court is whether the Agency’s decision comports with the evidence that was before it.
An agency’s interpretation of a statute and its own regulations “ultimately prevails, if at all, only by virtue of the persuasive power it exerts.” Barnett,
(i) The Purpose of the CHAMPUS/TRICARE Statute
“The CHAMPUS statute and regulations were enacted 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....’” Britell v. United States,
The program fulfills this objective by “supplementing] the military’s system of direct care for members of the armed services,” Wilson v. CHAMPUS,
“The truly outstanding feature of the Dependents’ Medical Care Act ... is that it converted the provision of military-dependent medical care from a mere act of grace to a full-fledged matter of right.” Barnett,
“While access to statutorily-authorized military-dependent medical care is a legal entitlement, Congress has imposed limitations on the types of care that CHAMPUS can supply....” Id. at 958. In particular, “[a]ny service ... which is not medically or psychologically necessary to prevent, diagnose, or treat a mental or physical illness ... as assessed or diagnosed by a physician [or] clinical psychologist ... may not be provided----” 10 U.S.C. § 1079(a)(13). However, a “broad-gauged reading of the statutory exclusions] [would be] antithetical to the general statutory purpose, for the prime objective of the Dependents’ Medical Care Act was enhancement, not reduction, of the benefits to be accorded to military personnel and their dependents.” Barnett,
The DoD “has no registry specifically for beneficiaries with ASD; [thus,] ... the prevalence of autism within the Military Health System is [not] known.” A.R., Vol. Ill, Tab 8-2-7 (DoD 2007 Report) at 6. Despite this uncertainty, in 2007, “the Marine Corps count[ed] 784 active duty family members of all ages with a diagnosis of ASD.” Id. In their amended complaint, the plaintiffs allege that the number of children of “active-duty military personnel [who] have been diagnosed with ASD ... [is] 13,243 of [an] estimated [total of] 1.2 million children.” Am. Compl. ¶ 120.
(a) Autism Defined
As discussed earlier, autism is classified as a Pervasive Developmental Disorder
The number of individuals diagnosed with autism has increased in recent years. A.R., Vol. Ill, Tab 8-2-13 (NIMH: Development Disorders) at 475. Professionals who have been certified to properly conduct a diagnostic assessment are equipped to determine if a child has autism before the child is two years old. Nat’l Research Council, Educating Children With Autism 3 (Catherine Lord & James P. McGee eds., 2001). When diagnosing autism, such professionals assess the behavioral symptoms produced by the’disorder. Am. Psychiatric Ass’n, supra, at 75. Three characteristics are commonly associated with autism: (1) “an inability to engage in reciprocal social interaction,” (2) “both verbal and non-verbal communication difficulties,” and (3) a “restricted imagination and a predilection for rigid routines.” F.J. O’Callaghan, Editorial, Autism: what is it and where does it come from?, 95 QJM 263 (2002).
The first category is manifested by autistic children encountering social challenges that restrict their ability to interact socially with others. A.R., Vol. Ill, Tab 8-2-13 (NIMH: Development Disorders) at 479-80. According to the NIMH, autistic children “appear to have tuned the world out and are in their own worlds, not paying attention to others or engaging in normal social interactions.” Cnty. Sch. Bd. of Henrico Cnty. v. R.T.,
As to the second category, autistic children possess language and communication barriers that prevent them from “grasp[ing] the point of communication.” Id. There are two components to this particular behavioral symptom: speaking and understanding. See id. In regard to the speaking component, “it has been estimated that half of [the] individuals affected by autism will remain mute throughout their lives.” Pace, supra, at 1798. If autistic children are able to speak, they “may experience delays in language development or only repeat what they have heard.” Id. When speaking, children with autism have challenges controlling the pitch, tone, and volume of their speech. O’Callaghan, supra, at 263. Also, affected children usually will have a “defect in understanding spoken speech [that] may be almost total, or may be subtle and merely take the form of literal interpretation of language.” Id.
Lastly, individuals with autism typically display repetitive behavior, obsession with routine, and sensory problems. Pace, supra, at 1798. The repetitive behavior can be manifested by constant rocking or repetition of the same bodily movement. Id. Affected individuals normally develop “an obsessive need for a routine.” O’Callaghan, supra, at 263. Thus, any deviation from the “usual pattern of life,” such as “a book out of place in a bookcase or an altered route home from school,” can cause minor outrage or temper tantrums. Id. In addition, in most cases of autism, individuals portray signs of restricted imagination and have sensory problems to the degree that “certain sounds can be overwhelming.” Id.; see also Pace, supra, at 1798.
These three types of manifestations are the common behavioral symptoms that lead to a diagnosis of autism. Am. Psychiatric Ass’n, supra, at 69. An early recognition of these characteristics or symptoms of autism can lead to an early diagnosis. See generally Nat’l Research Council, supra, at 195. And an early diagnosis is critical to the overall success of addressing autism, because it allows education and behavioral modification efforts to commence. Id.
(b) Mitigating the Impact of Autism
Even though there is no available cure for autism, various forms of intervention have been developed to mitigate its symptoms and effects. Pace, supra, at 1798. These interventions are categorized in four different methods: (1) early intervention programs, (2) specialized education, (3) family support, and (4) medication. Id. Through early intervention programs, professionals provide educational and behavior training services that are designed to enhance the development of language and social skills. Id. These educational programs can take on a more specialized form, in which they focus on the individual’s particular needs in order to “maximize the potential of each individual.” Id. The success of these programs is bolstered by additional support from the family. Id. Normally, family members work with teachers and therapists to enable them to continue the training efforts in the child’s home. Id. Such participation by the family becomes a constant support system for autistic individuals and the professionals who work with them. Id. Finally, certain symptoms can be treated with the use of medication, but medications do not alleviate the targeted symptom, they merely minimize the frequency and effects of that symptom. See id.
As the Agency’s own report to Congress notes, “[w]ithin the field of autism, there are many approaches to intervention that are widely disseminated but little researched.” A.R. Vol. Ill, Tab 8-2-7 (DoD 2007 Report) at 411. “Some approaches
(c) ABA Therapy
ABA therapy is the “application of behavioral principles to shape behaviors and teach new skills in an individual.” A.R., Vol. Ill, Tab 8-2-7 (DoD 2007 Report) at 8. As a continuous chain of discrete “lessons one-on-one with a student taught with very clear beginnings and endings, repeated over and over, with positive reinforcement[,]” Gill v. Columbia 93 Sch. Dist., No. 98-4192-CV-C-66BAECF,
ABA therapy is a specialized intervention administered by a “professional with advanced formal training in behavioral analysis.” McHenry v. PacificSource Health Plans,
ABA therapy is an economically “costly” program, and can be physically and emotionally demanding on the family of a child diagnosed with autism. McHenry, 679 F.Supp,2d at 1232. The family members of an affected child become a core component of the intervention because they must invest a substantial amount of time at home reinforcing the therapy so that the “gains made by the child with his therapist are not lost.” C.M. ex rel. J.M.,
(ii). The Applicability of the TRICARE Statute to Autism
As noted previously, the purpose of the TRICARE Basic 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.” Britell,
c. Is ABA Therapy “Unproven” “Medical Care, ” Even If It Qualifies as “Medical Care”?
As noted earlier in this opinion, in accordance with its statutory mandate, the Agency has adopted a regulation for the administration of the TRICARE military
A drug, device, or medical treatment or procedure is 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] 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 safety, or its effectiveness as compared with the standard means of treatment or diagnosis.
32 C.F.R. § 199.4(g)(15) (emphasis added).
[Reliable evidence means only: (i) [w]ell controlled studies ■ of clinically meaningful endpoints, published in refereed medical literature[;] (ii) [published formal technology assessments^] (iii) [t]he published reports of national professional medical associations^] (iv) [published national medical policy organization positions; and (v) [t]he published reports of national expert opinion organizations.
32 C.F.R. § 199.2.
In addition to the Basic Program, Congress established ECHO, an extended benefits program that is available only to active duty members and their dependents, which is also administered by the Agency. See 10 U.S.C. § 1079(d). The purpose of ECHO is “to provide an additional financial resource for an integrated set of services and supplies designed to assist in the reduction of the disabling effect of the ECHO-eligible dependent’s qualifying condition.” 32 C.F.R. § 199.5(a)(2). Care provided under ECHO is not limited to medical care, and the Agency has discretion to provide coverage for services determined by the Agency to be appropriate, “notwithstanding the limitations in subsection (a)(13)” that “[a]ny service or supply which is not medically or psychologically necessary ... may not be provided.” See 10 U.S.C. § 1079(e)(7) (“Extended benefits for eligible dependents under subsection (d) may include ... [s]uch other services and supplies as determined appropriate by the Secretary, notwithstanding the limitations in subsection (á)(13).”). The Agency is therefore at liberty to reimburse active military service members for ABA therapy provided to their dependents without determining whether it was medically or psychologically necessary, whereas it cannot do so in the case of non-active duty service members.
This leaves the Court to determine whether the plaintiffs’ reimbursement requests were properly denied on the basis that ABA. therapy is unproven. “The scope of review under the ‘arbitrary and capricious’ standard is narrow and a court is not to substitute its judgment for that of
arbitrary and capricious if the agency has relied on factors which Congress has not intended it to consider, entirely failed to consider an important aspect of the problem, offered an explanation for its decision that runs counter to the evidence before the agency, or is so implausible that it could not be ascribed to a difference in view or the product of agency expertise.
Motor Vehicle Mfrs. Ass’n of U.S.,
With this legal authority as its guide, the Court must resolve two questions in order to determine whether the Agency’s determination that ABA therapy is unproven is arbitrary and capricious. First, the Court must examine whether the Agency’s determination was based on a consideration of all the relevant factors. See Bowman Transp. Inc.,
(i) Did the Agency Fail to Articulate a Satisfactory Explanation Due to its Reliance Solely on the Sources Referenced in its Final Formal Review Decision?
The plaintiffs argue that the Agency erroneously “dismissed ... as not reliable,” and therefore failed to give appropriate consideration to several studies they submitted to the Agency which identify ABA therapy as an effective treatment modality for ASD, all of which they contend comport with the Agency’s reliable evidence standard. See Pis.’ Mem. at 50-51 (stating that the Agency did not consider the following sources as reliable and therefore they were not accorded proper consideration in the Agency’s decision: (1) an article with recommendations from the Association for Science in Autism Treatment (“ASAT”), (2) a report entitled “Mental Health: A Report of the Surgeon General,” (3) a letter from autism experts to the United States Armed Services Committee dated September 19, 2008, and (4) a letter from autism organizations to Secretary Gates dated May 19, 2008. Moreover, the plaintiffs assert that this error is particularly egregious because these sources are reliable sources under the Agency’s own regulatory standard. Id. at 38-40.
The Agency counters the plaintiffs’ arguments, representing that it based its final formal review decision on the following sources:
(1) the applicable sections of Title 10 [U.S.C.] Chapter 55 ...; (2) 32 C.F.R. Part 199 ...; (3) policy manuals, instructions, procedures, and other guidelines issued by the Assistant Secretary*127 of Defense for Health Affairs (ASD/HA), the TMA Director, or their designees ...; (4) the record on appeal; (5) additional information and argument presented by the Beneficiary; (6) the technical assessment issued by the TMA Deputy Chief Medical Officer; (7) the TRICARE benefit determination approved by the TMA Director on October 19, 2010; and (8) the October 25, 2010, Hayes, Inc. technology assessment, [entitled] Intensive Behavioral Intervention for Autism.
A.R., Vol. I, Tab 1 (Formal Review Decision) at 2-3.
Although the Director of the TMA stated that he reviewed materials submitted by the plaintiff, id., he offers no specific insight regarding his consideration of those materials, nor does he explain why it was determined that some of the materials submitted to the Agency failed to satisfy its reliable evidence standard, id. at 11; see FCC v. Fox Television Stations, Inc.,
In its memorandum in support of its summary judgment motion, the Agency simply’declares that its adjudication of the plaintiffs’ case was based on the sources listed above, which it contends shows that it considered all of the relevant factors. See Def.’s Mem. at 23 (“This adjudication, based on the technical assessment and benefit determination reviewed in light of the medical literature and [the A]gency’s regulations, constitutes a consideration by DoD of the relevant factors for assessing whether ABA is covered under the TRI-CARE Basic Program.”). However, the Agency has failed to articulate why the sources submitted by, the plaintiffs, for example, the United States Surgeon General’s report entitled “Mental Health: A Report of the Surgeon General” (June 2, 2010), A.R., Vol. Ill, Tab 8-2-16 (“June 2010 Report of Surgeon General”), do not constitute reliable evidence under 32 C.F.R. § 199.2, which as noted earlier provides, in relevant part:
[r]eliable evidence means only (i) [w]ell controlled studies of clinically meaning*128 ful endpoints, published in refereed medical literature[;] (ii) [published formal technology assessments!;] (iii) [t]he published reports of national professional medical associations!;] (iv) [published national medical policy organization positions; and (v) [t]he published reports of national expert opinion organizations.
32 C.F.R. § 199.2. Specifically, the Agency has failed to explain why the plaintiffs’ submissions do not constitute “published national medical policy organization positions,” or “published reports of national expert opinion organizations.” See id. Without a “satisfactory explanation for its action!,] including a rational connection between the facts found and the choice made,” this Court must deem the Agency’s action arbitrary and capricious. Motor Vehicle Mfrs. Ass’n of U.S.,
(ii) Is the Agency’s Reliance on Smith v. Office of Civilian Health & Medical Program of Uniformed Services Misplaced?
The Agency attempts to draw parallels between this case and Smith v. Office of Civilian Health & Medical Program of Unifomed Servs.,
For two reasons, this Court is not persuaded that Smith supports the Agency’s determination that ABA therapy is unproven. First, as the plaintiffs aptly point out, the level of dispute and controversy over the breast cancer treatment at issue in Smith stands in stark contrast to the many members of the medical community’s favorable assessment of ABA therapy. Compare, e.g., Smith,
Here, there is no evidence that ABA therapy is the subject of such acrimonious debate within the medical community, as was the case in Smith; rather, there appears to be a general consensus that ABA therapy does indeed improve the functioning of children with ASD. See A.R., Vol. IV, Tab 11 (Focal Educational and Behavioral Interventions for the Treatment of Autism Spectrum Disorders (ASDs) From the ECRI Institute. Health Technology Assessment Information Service (2009) (“2009 ECRI Report”)) at 572 (“[ABA' therapy] was recommended by several guidelines groups.”). While medical professionals in Smith disagreed as to the core medical value of the breast cancer therapy at issue as compared to more established treatments,
Moreover, there is no evidence that ABA therapy carries any risk of harmful side effects, whereas in Smith there was considerable debate about the risks associated with the breast cancer treatment at issue in that case.
(iii) Is the Defendant’s Coverage of ABA Therapy Under ECHO, But Not Under the Basic Program, Arbitrary and Capricious, Contrary to Law, or Otherwise Not in Accordance With Law?
The plaintiffs argue that by providing coverage for ABA therapy under ECHO, the Agency has necessarily made a determination that ABA therapy is “safe” and “effective,” Pis.’ Reply at 7, because all services covered under the ECHO program, whether medical or therapeutic, are subject to the same efficacy requirements as those covered under the Basie Program, see Pis.’ Mem. at 46-47; see also Pis.’ Reply at 24 (“[T]he ECHO regulation that adopts by reference the ‘proven’ standard under the Basic Program, applies not only to ‘medical care’ but also to ‘therapeutic services.’ ”). The Agency counters, arguing that although it is true that ECHO requires both medical and therapeutic treatments to satisfy the same reliable evidence standard as required under the Basic Program, the Agency “has great discretion in providing coverage under ECHO for other forms of treatment that can assist in the alleviation of a disabling condition.” Defs.’ Reply at 14; see also 10 U.S.C. § 1079(e)(7) (“Extended benefits for eligible dependents under subsection (d) may include ... other services and supplies as determined appropriate by the [defendant], notwithstanding the limitations in subsection (a)(13).”).
Since, as noted earlier, the Agency is correct in stating that Congress has granted it discretion to provide coverage for treatments under the ECHO program that are “not medically or psychologically necessary,” see 10 U.S.C. § 1079, the issue for the Court to address is whether the Agency’s decision to cover ABA therapy under the ECHO program without extending such coverage under the Basic program is nonetheless arbitrary and capricious, contrary to law, or otherwise not in accordance with the law.
The Agency’s decision to provide, on the one hand, ECHO coverage for ABA therapy, while on the other hand, to withhold coverage under the Basic Program, is obviously contradictory because if the Agency concluded that ABA therapy is unproven, the Agency should not cover ABA therapy under either the ECHO or the Basic Program, because both programs are governed by the same “reliable evidence” standard. The Court understands, and
(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) (emphasis added). Added to the Court’s concerns about the inconsistent position the DoD has taken is the fact that the Agency itself has stated that “healthcare services” requiring ABA intervention were approved as “medically necessary ... covered benefits” pursuant to the above regulation in a patient coverage determination in 2008. Plaintiffs’ Motion for Summary Judgment to Set Aside, As Contrary to Law, Defendants’ Policy That Applied Behavioral Analysis (ABA) Therapy Is “Special Education” Rather Than Health Care, Ex. 11 at 1. The regulation used as support for that decision relies on the same regulatory framework used to deny the same treatment to Z.B. under the Basic Program.
Also troubling is that the Agency’s decision appears to run counter to several of its justifications for determining that ABA therapy is unproven care. Again, the Agency cites the Seventh Circuit’s decision in Smith as support for its position, suggesting that its conclusion that ABA therapy is unproven was, as just noted, at least partially based on its concern that ABA therapy may have unknown and harmful side effects, and thus requires additional research to establish its safety. The Agency cannot rationally base its denial of ABA therapy coverage under the Basic Program on a concern that ABA therapy may be harmful to autistic children, while at the same time providing ABA therapy coverage under the ECHO program. Even under the most deferential review, the Court cannot comprehend a rational connection between the Agency’s decision to exercise its discretionary authority under Section 1079(e)(7) of Title 10 of the U.S.Code to provide coverage for ABA therapy under ECHO, while refusing to provide coverage for ABA therapy under the Basic Program based on safety concerns.
Furthermore, even if the Court could agree with the Agency’s position that ABA therapy does not satisfy its standard for what constitutes proven care, the Agency has conceded that there is considerable evidence in the medical community demon
In light of the facts before it and the state of the law — the views of the medical community concerning the effectiveness of ABA therapy, Congress’ express purpose for enacting the military health benefits statute, the Supreme Court’s and the District of Columbia Circuit’s jurisprudence requiring that statutes conferring benefits to Armed Service members be construed in favor of the beneficiaries, and the complete lack of evidence that ABA therapy may have harmful side effects — the Agency’s decision to enforce its stringent regulatory standards to withhold ABA therapy coverage under the Basic Program, while exercising its statutorily-granted discretion to extend ABA therapy coverage under ECHO, seems highly suspect. The Court is left to speculate why the Agency chose to create this two prong regulatory scheme in light of the Agency’s failure to provide a reasoned explanation for it. This deficiency alone is sufficient to render the Agency’s decision to extend ABA therapy coverage to the ECHO program, without also extending coverage to the Basic Program, arbitrary and capricious. See Barrington,'
(iv) Did the Defendants Give Proper Consideration to the Purpose of the Military Health Benefits Statute In Determining That ABA Therapy is Not Proven Care?
The Agency’s determination that ABA therapy is unproven and thus not covered under the Basic Program is even more troubling when considered in context with the stated purpose for the military health benefits statute’s adoption. See 10 U.S.C. § 1071 (“The purpose of this chapter is to create and maintain high morale in the uniformed services by providing an improved and uniform program of medical ... care.... ”). The plaintiffs argue that any competing interpretations of the mili
It is well-established that laws conferring benefits to members of the Armed Services must be construed generously in favor of the nation’s military service members. See, e.g., King v. St. Vincent’s Hosp.,
(v) Did the Defendants Ignore Their Own Regulations In Declaring ABA Therapy “Unproven”?
The Agency has not demonstrated a rational connection between its conclusion that ABA therapy is unproven and the relevant factors it considered in its Formal Review Decision. As discussed above, the sources the Agency considered in making its determination that ABA therapy is unproven do not suggest that ABA therapy is ineffective. On the contrary, each of the technology assessments relied upon by the Agency indicates that ABA therapy has been shown effective in treating some children with autism. See, e.g., A.R., Vol. I, Tab 4, 2010 (Hayes Report) at 53 (“[I]n general, the findings show that [ABA] therapy significantly raises IQ scores and increases the proportion of children in regular classroom settings.”); A.R., Vol. IV, Tab 10 (2008 ECRI Report) at 322 (“After one year of treatment, children with ASD who receive [ABA therapy] score higher on tests of IQ.”); A.R., Vol. IV, Tab 12 (Special Report: Early Intensive Behavioral Intervention Based on Applied Behavioral Analysis among Children with Autism Spectrum Disorders From the BlueCross BlueShield Association (“BCBS TEC Report”)) at 720 (acknowledging that “ABA is among the most commonly cited and best-researched intervention for ... children [with autism]”). While acknowledging these findings, the Agency seizes on language in these reports indicating that further research is needed to establish the efficacy of ABA therapy. See Defs.’ Reply at 21 (“These ‘technology assessments’ found that the efficacy of ABA as a ‘proven’ ‘medical’ modality is not well-supported in the literature but rather additional research and better controlled studies [are] needed.”). It is true, according to the Agency’s own regulation, that a treatment is “not proven” 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 safety, or its effectiveness as compared with the standard means of treatment or diagnosis.” 32 C.F.R. § 199.4(g)(i)(D) (emphasis added). However, the Court has identified several problems with the Agency’s application of this regulation to the facts of this case.
First, none of the sources considered by the Agency in making its determination questions either the safety or the efficacy of ABA therapy. As discussed above, none of these assessments has provided any evidence that ABA therapy has negative side effects or that it may be harmful to children with autism. Second, each assessment includes several sources that
IV. Conclusion
In APA cases, “a district court reviewing a final agency action does not perform its normal role but instead sits as an appellate tribunal.” Palisades Gen. Hosp. Inc. v. Leavitt,
Because the Agency’s denial of ABA therapy coverage under the Basic Program is arbitrary and capricious, the Agency must therefore be enjoined from denying qualified beneficiaries coverage on the ground that ABA therapy is not a covered benefit under the TRICARE Basic Program. Thus, the Court will remand this case back to the Agency with instructions that ABA therapy coverage be provided to Basic Program beneficiaries who otherwise qualify for reimbursement and such reimbursement be provided in compliance with the applicable TRICARE guidelines for the expenses incurred by qualified beneficiaries to acquire ABA therapy for their children.
SO ORDERED this 26th day of July, 2012.
Notes
. The Court preliminarily granted class certification under Federal Rule of Civil Procedure 23(b)(2) to the following class: "All individuals with autism who are TRICARE Basic [PJrogram beneficiaries, and their parents and guardians, and who currently or in the future seek TRICARE Basic [P]rogram coverage for [Applied Behavior Analysis] therapy.” Order at 1, Berge v. United States, No. 10-0373 (D.D.C. March 4, 2011). Class certification was preliminarily granted pending the Court’s resolution of the cross-motions for summary judgment that are the subject of this Opinion.
. TMA is the field activity within the Department of Defense that administers the TRICARE Basic Program. Defendants’ Memorandum In Support of Their Motion to Dismiss Or, In the Alternative, to Hold This Action In Abeyance at 2.
. The Court has substituted Leon E. Panetta, the current United States Secretary of Defense, for former Secretary Gates pursuant to Federal Rule of Civil Procedure 25(d).
. In addition to the filings already identified, the Court considered the following submissions in rendering its decision: (1) Plaintiffs’ Class Action Complaint and Demand for Jury Trial ("Compl.”); (2) Plaintiffs' Statement of Points and Authorities in Support of Motion for Class Certification ("Pis.” Mem. to Certify”); (3) Statement of Points and Authorities in Support of Plaintiffs' Renewed Motion for Summary Judgment ("Pis.’ Mem.”); (4) Plaintiffs' Reply Memorandum in Support of Their Renewed Motion for Summary Judgment and Memorandum in Opposition to Defendants’ Cross-Motion for Summary Judgment ("Pis.' Reply”); (5) Defendants’ Reply to Plaintiffs' Opposition to Defendants' Motion for Summary Judgment ("Defs.’ Reply”); and (6) Defendants’ Memorandum In Support of Their Motion to Dismiss Or, In the Alternative, to Hold This Action In Abeyance.
. Autism is a developmental disorder and will be described in fuller detail later in this opinion.
. The “Basic Program will pay for medically necessary services and supplies required in the diagnosis and treatment of illness or injury.” 32 C.F.R. § 199.4(a)(l)(i). As the defendants point out, many of the regulations and case law interpreting those regulations still refer to the Program as "CHAMPUS,” as opposed to TRICARE. The "Basic Program” under TRICARE is available to, among others, retired service members and the dependents of both active duty and retired service members, while TRICARE’s Extended Health Care Option ("ECHO”) is available only to active duty service members and their dependents. See 32 C.F.R. § 199.4-.5.
. Although the TMA is the DoD component responsible for managing the Basic Program, the plaintiffs make a number of arguments in their motion directed at the DoD, rather than the TMA. The Court will specifically reference both of these defendants throughout this opinion where appropriate.
. NIMH is the acronym for the National Institutes of Mental Health.
. Some of the exhibits submitted by the parties are not numbered. Therefore, the Court has taken the liberty of assigning them numbers consistent with the order in which they appear on the Court’s electronic filing system.
. The page numbers cited are those assigned to the Administrative Record by the Agency.
. Section 1076(e)(3) of Title 10 of the United States Code states, in relevant part, that "[m]edical and dental care furnished to a dependent ... shall be limited to the health care prescribed by section 1077 of this title.” Section 1077 lists the following categories of care: hospitalization; outpatient care; drugs;' treatment of medical and surgical conditions; treatment of nervous, mental, and chronic conditions; treatment of contagious diseases; physical examinations, including eye examinations, and immunizations; maternity and infant care, including well-baby care that includes one screening of an infant for the level of lead in the blood of the infant; diagnostic tests and services, including laboratory and X-ray examinations; dental care; ambulance service and home calls when medically necessary; durable equipment, which may be provided on a loan basis; primary and preventive health care services for women; preventive health care screening for colon or prostate cancer; prosthetic devices, as determined by the Secretary of Defense to be necessary because of significant conditions resulting from trauma, congenital anomalies, or disease; a hearing aid; 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. See 10 U.S.C. § 1077(a)(l)-(17).
. 30 U.S.C. §§ 1201, 1272(e) (2006).
. Although the term psychologically does not suffer from the same ambiguities and multiple definitions as the other terms, the Court must construe the phrase “medically or psychologically necessary” as a whole in assessing its ambiguity.
. The plaintiffs offer five additional arguments as to why the Agency does not deserve deference under Chevron step one. The Court need not consider the argument that the statutory language explicitly strips the Agency of its discretion because the Court has already found the statutory language to be ambiguous. In addition, the plaintiffs' argument that the Agency does not deserve deference because it lacks exclusive administrative authority over the military health benefits statute is unpersuasive because Congress delegated to the Secretary of Defense sole “responsibility
. As stated above, although Article 10 of the United States Code provides the statutory authorization for providing services under the Basic Program, “Title 32 Part 199 of the Code of Federal Regulations (32 C.F.R. 199) prescribes the guidelines and policies for the administration of the [Basic] Program.” A.R., Vol. I, Tab 1 (Formal Review Decision) at 22 (footnote omitted).
. Although some of the sources cited in this section of the opinion are not part of the
. JAMA is the acronym for the Journal of the American Medical Association.
. The QJM, a International Journal of Medicine, is a medical journal "focus[ing] on internal medicine and publisbfing] peer-reviewed articles which promote medical science and practice.” QJM, http://www.oxfordjournals. org/our_journals/qjmedj/about.html (2012).
. Technology assessments, when referred to in this opinion, relate to the various studies that were reviewed by the Agency in rendering its decision on whether ABA is a covered treatment under the Basic Program. A number of reports and studies reviewed by the Agency assessed ABA treatment to ascertain its level of effectiveness.
. The defendants do not address Barnett in the context of this argument. They reference it only in addressing whether ABA therapy is "medically or psychologically necessary.” See Def.'s Mem. at 16, n. 12. In that discussion, the defendants attempt to distinguish Barnett from this case by arguing that the dispute in Barnett was not whether a certain therapy was medically necessary, as in this case, but rather whether the, scope of the statutory exclusion for custodial care extended to care that was already deemed medically necessary. Id.
. As noted in Part I.C of this opinion, supra at 9, the Court stayed these proceedings while the TMA reconsidered whether ABA therapy is covered under the Basic Program; the TMA ultimately issued a formal review decision denying reimbursement for ABA therapy, thus preserving the same inconsistency.
. In an earlier footnote, the Court noted that the plaintiffs were preliminarily granted class certification; however, now that the Court has thoroughly familiarized itself with the claims of the class, with die issuance of this opinion, the Court will grant the plaintiffs permanent class action certification pursuant to Federal Rule of Civil Procedure 23(b)(2).
. The Court will contemporaneously issue an Order consistent with this Memorandum Opinion.