The opinion of the court was delivered by: Mae A. D'Agostino, U.S. District Judge:
MEMORANDUM-DECISION AND ORDER
On March 10, 2009, Plaintiffs brought this action pursuant to the Employee Retirement Income Security Act of 1974, 29 U.S.C. §§ 1001 et seq. ("ERISA"), for, among other things, reimbursement of medical expenses under an employee benefits plan relating to intravenous ("IV") antibiotic therapy used to treat Lyme disease. See Dkt. No. 1. On January 26, 2010, Magistrate Judge Baxter granted Plaintiffs' unopposed motion to amend the complaint. See Dkt. No. 22.
Currently before the Court are the parties' cross-motions for summary judgment and Defendants' cross-motion to strike the affidavits of Sherie A. Giles, Lewis P. Giles, Kenneth Liegner, M.D., and Peter G. Barber (the "Affidavits") submitted in support of Plaintiffs' motion for summary judgment, to the extent that the affidavits contain information that is not contained in the Administrative Record.
Plaintiffs are married and reside in Northhampton, New York. See Dkt. No. 40-1 at ¶ 2. Plaintiff Sherie Giles is a former management employee with Defendant AT&T. See id. at ¶ 3.
Defendant AT&T maintained Defendant AT&T Umbrella Benefit Plan No. 1--AT&T Medical Plan (the "Plan") -- an employee benefit plan subject to ERISA. See id. at ¶ 4. The Plan identifies Defendant AT&T as the "Plan Sponsor" and "Plan Administrator," however, Defendant United Healthcare Insurance Company ("UHIC") has been delegated discretionary authority by Defendant AT&T to make benefits determinations under the Plan. See id. at ¶ 5; Dkt. No. 46 at ¶
5. The Plan provides for the filing of claims for covered health services with the Claim Administrator. Within thirty days of receipt of the claim, the Claims Administrator provides the claimant with a benefit determination for each claim submitted. Pursuant to the terms of the Plan, a denial notice must explain the reason for the denial, refer to the part of the Plan on which the denial is based, and provide the claimant with the claim appeal procedures necessary to challenge the determination. See Dkt. No. 40-1 at ¶ 6.
Plaintiff Sherie Giles is an eligible retiree of Defendant AT&T and is a qualified participant in the Plan. See id. at ¶ 7. As her husband, Plaintiff Lewis Giles is also a qualified participant in the Plan. See id.
Beginning in 1987, Plaintiff Sherie Giles began experiencing symptoms of illness, which were later attributed to one or more tick-borne infections, including Lyme disease. See Dkt. No. 40-1 at ¶ 9; Dkt. No. 46 at ¶ 9. Plaintiff retired from Defendant AT&T's employ in 1996 because her illness made it so that she could no longer discharge her responsibilities. See Dkt. No. 40-1 at ¶ 10; Dkt. No. 46 at ¶ 10.
After a prolonged period of unsuccessful treatment, Plaintiff Sherie Giles began treatment with Dr. Kenneth P. Liegner. See Dkt. No. 40-1 at ¶¶ 11-12; Dkt. No. 46 at ¶¶ 11-12. In a Consultation Record dated October 31, 1997, Dr. Liegner recorded Plaintiff Sherie Giles' chief complaints, including fatigue, headache, joint and muscle pain and achiness, depression, sleep disturbance, ringing in the ears, and abdominal bloating. See Dkt. No.40-1 at ¶ 14; Dkt. No. 46 at
¶ 14. Following subsequent laboratory tests and clinical evaluation, Dr. Liegner diagnosed Plaintiff Sherie Giles with Lyme disease. See Dkt. No. 40-1 at ¶ 16; Dkt. No. 46 at ¶ 16.
Thereafter, in July of 2006, Plaintiff Sherie Giles consulted with Dr. Arniram Katz. See Dkt. No. 40-1 at ¶ 17; Dkt. No. 46 at ¶ 17. In a Consultation Record dated July 24, 2006, Dr. Katz recorded Plaintiff Sherie Giles' chief complaints, history, and examinations. Given the evidence of Lyme disease, Dr. Katz recommended IV antibiotic Rocephin*fn1 treatment for a minimum of ninety days and then to evaluate whether the symptoms improved. See Dkt. No. 40-1 at ¶ 18; Dkt. No. 46 at ¶ 18. In an Addendum dated November 4, 2006, Dr. Katz noted that, in a follow-up visit, he reviewed the results of diagnostic brain scans, i.e., PET, SPECT and MRI, at Yale New Haven Hospital. See Dkt. No. 40-1 at ¶ 19; Dkt. No. 46 at ¶ 19. Dr. Katz stated that these images provided further support for the need for treatment with IV antibiotics for Lyme disease. See id.
In a Private Contract for Medical Services dated January 1, 2007, Dr. Liegner informed Plaintiff Sherie Giles that he had opted out of the Medicare program and they agreed that charges for his services were Plaintiffs' responsibility. See Dkt. No. 40-1 at ¶ 21; Dkt. No. 46 at ¶ 21. In March of 2007, because of complications, Plaintiff Sherie Giles stopped taking her oral antimicrobial therapy. See Dkt. No. 40-1 at ¶ 22; but see Dkt. No. 46 at ¶ 22. Considering her deteriorating health, Dr. Liegner decided to start Plaintiff Sherie Giles on the recommended course of IV antibiotic therapy. See Dkt. No. 40-1 at ¶ 23; but see Dkt. No. 46 at ¶ 23.
In a letter dated March 23, 2007, Dr. Liegner requested a pre-service authorization from Defendant UHIC for the medical necessity of IV antibiotic treatment for Lyme disease with central nervous system indications. See Dkt. No. 40-1 at ¶ 24 (citing AR 2148); Dkt. No. 46 at ¶ 24. Dr. Liegner supported this request with copies of laboratory tests indicative of Lyme disease, and Dr. Katz's consultation record which recommended IV antibiotic therapy. See id. In a response dated April 11, 2007, Defendant UHIC stated that "BENEFITS WILL BE ALLOWED FOR THE PROPOSED CODE J0696,"*fn2 but qualified its approval as follows:
PAYMENT OF CHARGES WILL BE SUBJECT TO PATIENT ELIGIBILITY AT THE TIME SERVICES ARE PROVIDED. THE PATIENT WILL ALSO BE RESPONSIBLE FOR ANY:
-- COINSURANCE AMOUNT, AND
See Dkt. No. 46 at ¶ 25; see also Administrative Record ("AR") at 2194.
On March 27, 2007, Dr. Liegner started Plaintiff Sherie Giles on a course of treatment of Rocephin (Ceftriaxone) by means of an IV infusion through a surgically implanted port. She would generally visit Dr. Liegner's office weekly for dressing changes and huber needle and infusion tubing. Dr. Liegner would generally examine and evaluate Plaintiff Sherie Giles every two weeks. See Dkt. No. 40-1 at ¶ 26 (citing AR 774-75).
With the initiation of the IV antibiotic therapy, Dr. Liegner
submitted claims on Plaintiff Sherie Giles' behalf to Defendant UHIC
for services rendered. See id. at ¶ 28 (citing AR 757-1191). In
support of the claims, Dr. Liegner subsequently submitted
documentation supporting the need for treatment, including the
Treatment Guidelines of the International Lyme and Associated Diseases
Society ("ILADS"),*fn3 and studies of the effects of
long-term IV antibiotic treatment for Lyme disease. See id.*fn4
In a letter dated February 20, 2008, Defendant UHIC notified
Plaintiffs that it was denying Plaintiff Sherie Giles' claims for
services that were obtained subsequent to November 8, 2007.
In a letter dated August 18, 2009, Dr. Liegner summarized his treatment of Plaintiff Sherie Giles and the progress she made while under his care. See AR at 3185-86. Specifically, Dr. Liegner summarized Plaintiff Sherie Giles' treatment, condition, and progress as follows:
Prior to March of 2007, Sherie Giles had been treated with oral and intramuscular antibiotics which had been only partially effective in arresting the progression of her chronic neurologic Lyme infection. In May 2006, her neurologist had recommended initiating a course of IV Rocephin. Throughout the succeeding nine months, she attempted to arrange for a local physician to administer this IV treatment. However, she found that she was unable to obtain this treatment from physicians in her health plan network. By March 2007, after the onset of severe tinnitis, she stopped taking her oral anti-microbial therapy. Her overall functioning thereafter rapidly declined and she began to exhibit a wide variety of new psychiatric and sensory problems. Hyperacusis and other forms of sensory overload became debilitating. She seemed to have lost or severely distorted her perception of time. She could not listen to music or watch TV due to not following time sequences. Language function was also quite bizarre, at times, often degenerating to gibberish. Her attention span was often barely over a second, but at other times was almost normal. With all of these changes, she also had much panic. Only with the full time and frankly heroic efforts of her husband, a psychologist, was she able to avoid hospitalization or a nursing home, obtain the surgical implantation of an IV port, and initiate the treatment.
After two months of the IV antibiotic therapy, her language generally normalized, and the severe Lyme induced organic brain syndrome began to relent. Thereafter, progress was slow but steady so long as the treatment continued. In July of 2008, Sherie Giles' liver enzymes became sufficiently elevated to warrant suspending the therapy for a period of two weeks. It thereafter became evident that the culprit causing the liver enzyme elevation was Nexium prescribed by her gastrointerologist for a peptic ulcer rather than the antibiotic. But it was noteworthy that during the period off antibiotic therapy, she experienced a significant decline in cognitive functioning. Upon resumption of treatment, the decline was reversed and cognitive improvement, albeit again slow, continued at a gradual but steady pace.
In April of 2009, with an apparent leveling off of her progress, treatment was suspended to see if gains would hold. Cognitive and emotional functioning has held steady. Significant fatigue and frequent muscle soreness, however, persist. Sherie Giles is now being continued on oral and intra-muscular antibiotic therapies along with anti-babesia therapy and other supportive therapies to address the current persistent symptoms.
See AR at 3185-86; see also AR at 3187 (providing letter of Dr. Mittelman dated August 20, 2009, also concluding the necessity of IV antibiotic treatment and the benefits that it has served).*fn5
Upon receiving notice that Plaintiff Sherie Giles' claims for IV antibiotic treatments, which were obtained subsequent to November 8, 2007, were denied, Plaintiffs appealed. Plaintiffs submitted two levels of appeal for services that Plaintiff Sherie Giles received for the following time periods: (1) January 1, 2008 through November 12, 2008, and (2) November 13, 2008 through April 16, 2009.
Defendant UHIC is the claims administrator under the Plan. According to the Plan, Defendant AT&T has delegated to Defendant UHIC, as its claims administrator, "the exclusive right to interpret and administer the provisions of the Plan." See AR at 274.
The Plan also states that "[c]ertain medical services are not covered by [the Plan]." See id. at 251. For example, the Plan provides that "Experimental or Investigational Services or Unproven Services are excluded. The fact that an Experimental or Investigational Service or an Unproven Service, treatment, device or pharmacological regimen is the only available treatment for a particular condition will not result in Benefits if the procedure is considered Experimental or Investigational or Unproven in the treatment of that particular condition." See id. at 251. The Plan defines "Unproven Services" as follows:
Unproven Services are services that are not consistent with conclusions of prevailing medical research which demonstrate that the health service has a beneficial effect on health outcomes and that are not based on trials that meet either of the following designs:
-Well-conducted randomized controlled trials. (Two or more treatments are compared to each other, and the patient is not allowed to choose which treatment is received.) -Well-conducted cohort studies. (Patients who receive study treatment are compared to a group of patients who receive standard therapy. The comparison group must be nearly identical to the study treatment group.)
See id. at 321. Moreover, the Plan provides that "[d]ecisions about whether to cover new technologies, procedures and treatments will be consistent with conclusions of prevailing medical research, based on well-conducted ...