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Jacobs v. Guardian Life Insurance Company of America

July 27, 2010

WILLIAM T. JACOBS, JR., PLAINTIFF,
v.
THE GUARDIAN LIFE INSURANCE COMPANY OF AMERICA AND BILL JACOBS MOTORSPORT, INC. HEALTH INSURANCE PLAN, DEFENDANTS.



The opinion of the court was delivered by: Judge Virginia M. Kendall

MEMORANDUM OPINION AND ORDER

Plaintiff William T. Jacobs, Jr. ("Jacobs") filed suit against Defendants Guardian Life Insurance Company of America ("Guardian") and Bill Jacobs Motorsport, Inc. Health Insurance Plan ("the Plan") (collectively "Defendants") pursuant to Sections 502(a)(1)(B) and 502(a)(3) of the Employee Retirement Income Security Act ("ERISA"), 29 U.S.C. § 1145, seeking recovery of health insurance benefits. Jacobs and Defendants have filed cross-motions for summary judgment. For the reasons stated below, the Court denies Jacobs' Motion for Summary Judgment and grants Defendants' Cross-Motion for Summary Judgment.

STATEMENT OF UNDISPUTED FACTS*fn1

Jacobs is employed by Bill Jacobs Motorsport, Inc., a car dealership in Naperville, Illinois. (Def. 56.1 Resp. ¶ 2.) Guardian issued a health insurance policy ("the Policy") to Jacobs Motorsport providing benefits to its employees; as such, Guardian qualifies as a fiduciary under 29 U.S.C. § 1002(21)(A). (Def. 56.1 Resp. ¶¶ 2, 4, 6; Pl. 56.1 Resp. ¶ 3.) At all times relevant to this litigation, the Plan offered health insurance benefits to Jacobs through the Policy issued by Guardian. (Pl. 56.1 Resp. ¶ 4.) As such, Jacobs qualifies as a participant under 29 U.S.C. § 1002(1). (Pl. 56.1 Resp. ¶ 4.) Guardian insured the Policy, processed claims under the Policy, and made determinations of benefits eligibility under the Policy. (Def. 56.1 Resp. ¶ 3; Pl. 56.1 Resp. ¶ 6.)

In 2004, Jacobs was diagnosed with a rare form of bile duct cancer called metastatic cholangiocarcinoma. (Def. 56.1 Resp. ¶ 11.) Jacobs has been under the care of Dr. Thomas Brown, Chief Operating Officer and Professor of Medicine at the University of Arizona College of Medicine Cancer Center and other physicians at the University of Texas MD Anderson Cancer Center ("MD Anderson") since that time. (Def. 56.1 Resp. ¶ 12.)

I. Jacobs' Medical History and Benefit Claims

A. Intensity Modulated Radiation Therapy

After Jacobs' initial chemotherapy treatments ended in November 2005, his treating physician began a regimen of Intensity Modulated Radiation Therapy ("IMRT") to the liver with concurrent chemotherapy and radiation therapy. (Pl. 56.1 Resp. ¶ 8; Def. 56.1 Resp. ¶ 13.) Jacobs submitted a claim to Guardian for payment for the IMRT. (Pl. 56.1 Resp. ¶ 8; Def. 56.1 Resp. ¶ 13.)

1. March 29, 2006 Peer Review Report by MES Solutions

On March 29, 2006, MES Solutions ("MES"), a peer review agency, prepared a "Peer Review Report" examining whether IMRT could "be considered sufficiently investigated to show that IMRT is as effective as more standard radiation therapy treatments for [Jacobs'] diagnosis." (Pl. 56.1 Resp. ¶ 9; Def. 56.1 Exhibit 2, pp. 2-3.) After reviewing correspondence, claim forms, and clinical information, a peer review physician from MES, Dr. Harold E. Kim ("Dr. Kim"), rendered a report finding that "IMRT cannot be considered sufficiently investigated to show that IMRT is as effective as more standard radiation therapy treatments for metastatic cholangiocarcinoma." (Pl. 56.1 Resp. ¶ 9; Def. 56.1 Exhibit 2, p. 3.) Noting that no published reports of prospective randomized clinical studies involving IMRT existed at the time, Dr. Kim further concluded that there was a lack of information about clinical outcomes of IMRT for intrahepatic tumors. (Pl. 56.1 Resp. ¶ 9.) "Radiation therapy, including IMRT, to a primary tumor site," he noted, "cannot be considered a standard of care for stage IV cholangiocarcinoma with metastatic lesions to peritoneum and ribs." (Pl. 56.1 Resp. ¶ 9; Pl. 56.1 Exhibit 2, p. 265.) Finally, Dr. Kim stated that radiation therapy would at best provide local control at the primary site of the cancer, but that the local failure rate for bile duct cancer remains high in spite of radiation treatment. (Pl. 56.1 Resp. ¶ 9.) The MES Report identifies Dr. Kim as "Board Certified in Radiology" with a "Sub Specialty Certificate in Radiation Oncology." (Def. 56.1 Exhibit 2, p. 3).

2. March 29, 2006 Denial of Benefits Letters

On March 29, 2006, Guardian sent letters to MD Anderson denying Jacobs' IMRT claim and noting that MES's peer review physician had determined that IMRT was not sufficiently investigated to establish that it was more effective than standard radiation therapy. (Pl. 56.1 Resp. ¶ 10; Def. 56.1 Resp. ¶ 14.) The letters further explained that IMRT was not considered the standard of care for Jacobs' type of cancer. (Pl. 56.1 Resp. ¶ 10; Def. 56.1 Resp. ¶ 14.) The letters stated that Guardian's determination was based on a peer review report obtained from MES and that Anderson had the right to appeal this claim denial. (Pl. 56.1 Resp. ¶ 10; Def. 56.1 Resp. ¶ 14.) They did not, however, refer to any provision in the Policy requiring that medical treatment needs to be "more effective" than a "standard treatment" or meet any specific "standard of care." (Def. 56.1 Resp. ¶ 15.) The letters did not identify a specific internal rule, guideline, or protocol relied upon or present a detailed scientific or clinical basis for the determination. (Def. 56.1 Resp. ¶ 15; Am. Compl., Exhibit B.) One of the letters did, however, state that "[u][pon request the Clinical Review Criteria relied upon and all information pertaining to this determination is available." (Def. 56.1 Resp. ¶ 15; Am. Compl., Exhibit B.)

3. April 25, 2006 Appeal Letter by MD Anderson

MD Anderson sent a letter of appeal on behalf of Jacobs seeking reconsideration of Guardian's denial of benefits on April 25, 2006. (Pl. 56.1 Resp. ¶ 11.) In the letter, Jacobs' treating physician stated that IMRT was selected as the safest and most effective treatment for Jacobs because of the contours of his tumor and the way it was situated in relation to his adjacent organs. (Def. 56.1 Resp. ¶ 18.) The treating physician further opined that IMRT was necessary treatment for Jacobs' cancer. (Def. 56.1 Resp. ¶ 18.) The letter noted that "[i]n uncommon disease sites, it will never be possible to demonstrate with adequate certainty in scientific studies that this methodology improves outcome." (Pl. 56.1 Resp. ¶ 11; Pl. 56.1 Exhibit 1, Exhibit C, p. 2.) It explains:

[M]any insurance companies require evidence from well-controlled clinical trials published in peer-reviewed medical literature to support the non-investigational status of a medical service. [However,] this type of interpretation does not recognize the fact that the literature often lags at least one year behind the actual clinical practice and that for many medical services, these types of controlled studies may never be available. (Pl. 56.1 Resp. ¶ 11.)

On May 3, 2006, Guardian submitted MD Anderson's April 25, 2006 appeal letter and medical records regarding Jacobs' treatment to the Medical Review Institute of America, Inc. ("MRI"). (Pl. 56.1 Resp. ¶ 12.)*fn2 Guardian's May 3, 2006 letter to MRI stated in relevant part:

A recent review showed that IMRT may not have sufficient scientific evidence to support it's [sic] use in some cancer diagnoses (including cholangiocarcinoma), may not be considered standard of care, and in selected instances is deemed investigational by some insurance plans. Following an independent physician consultant view of records submitted by MD Anderson, the radiation services were denied as of being a covered benefit under the member's plan. MD Anderson has appealed this decision. (Def. 56.1 Resp. ¶ 20.)

4. May 11, 2006 Peer Review Report by MRI

MRI submitted a peer review report to Guardian on May 11, 2006 concluding that there were still no data to support the efficacy of radiation therapy-either standard or IMRT therapy-for the treatment of metastatic cholangiocarcinoma, except for symptom control of isolated legions. (Pl. 56.1 Resp. ¶ 12.) "In the most current edition of the NCCN Clinical Guidelines for Hepatobiliary Cancers," MRI's report noted, "radiation therapy is not indicated as an acceptable option for management of metastatic intrahepatic cholangiocarcinoma except as might be needed for comfort care." (Pl. 56.1 Resp. ¶ 12.) Additionally, the report stated that there were "insufficient data of high enough quality... to establish a useful consensus or standard of care. The literature on IMRT for this particular diagnosis is sparse and represents a limited number of patients in studies of poor quality concentrating mainly on technical feasibility and safety; IMRT cannot be considered 'sufficiently investigated' to establish its usefulness." (Pl. 56.1 Resp. ¶ 12.) Although the report indicates that among the records reviewed was MD Anderson's appeal letter, MRI did not directly address the statement in the letter that Jacobs' treating physician found IMRT to be efficacious and medically necessary for Jacobs. (Def. 56.1 Resp. ¶ 22; Pl. 56.1 Exhibit 7.) According to the report, the physician who conducted the review underlying MRI's report had been in practice since 1978 and was certified by the American Board of Radiology with a subspecialty in Therapeutic Radiology. (Pl. 56.1 Resp. ¶ 12.) He also served as Medical Director of Radiation and Associate Professor of Radiology at a medical school in the United States and as Chairman of the Board of Trustees for a local medical association. (Pl. 56.1 Resp. ¶ 12.)

5. July 24, 2006 Denial of Benefits Letter

On July 24, 2006, Guardian denied Jacobs' appeal, claiming that IMRT was "not sufficiently investigated to show that it is more effective than standard radiation therapy and that the treatment is not considered standard of care." (Def. 56.1 Resp. ¶ 19.) Although Guardian stated that its determination was based on the opinion of a "second independent physician consultant," it did not identify the consultant in the letter. (Def. 56.1 Resp. ¶ 19.) The "second independent physician consultant" referred to in Guardian's July 24, 2006 letter denying benefits is MRI. (Def. 56.1 Resp. ¶ 20.) In denying Jacobs' benefits, Guardian explained that it was relying on MRI's evaluation of whether IMRT proved efficacious for treatment of Jacobs' type of cancer and not whether it proved efficacious for treatment of Jacobs himself. (Def. 56.1 Resp. ¶ 22.) Guardian's letter did not point to any specific provision in the Policy requiring that the treatment prescribed as medically necessary be more effective than the standard treatment, but did state that "[u]pon request the Clinical Review Criteria relied upon and all information pertaining to this determination is available." (Def. 56.1 Resp. ¶ 19; Am. Compl., Exhibit D.)

B. Chemotherapy

Since 2007, Jacobs' treatment has included chemotherapy with: (1) a combination of the drugs Avastin and Abraxane; (2) a single use of either Avastin; (3) a singe use of Abraxane; or (4) a combination of the drugs Abraxane and Irinotecan. (Def. 56.1 Resp. ¶ 23.) Jacobs' treating physician has treated and is treating Jacobs with drugs that have been used for similar cancers based on his medical judgment given the molecular characteristics of Jacobs' tumor. (Def. 56.1 Resp. ¶ 23.) Guardian has never consulted with Jacobs' treating physician personally about the chemotherapy prescribed for his cancer, but instead has denied him benefits based on the reviews it requests and receives from independent peer review physicians. (Def. 56.1 Resp. ¶ 24.)

1. November 13, 2007 Peer Review Report by MRI

On August 21, 2007, Jacobs' treating physician began treating him with the combination regimen of Avastin and Abraxane and Jacobs subsequently submitted a claim for benefits. (Pl. 56.1 Resp. ¶ 14.) MRI submitted an "independent peer review" of this claim to Guardian on November 13, 2007. (Def. 56.1 Resp. ¶ 26; Pl. 56.1 Resp. ¶ 14.) Guardian provided Jacobs' treating records to MRI for purposes of this review but did not provide a narrative statement or description from his treating physician as to the efficacy of a combination of Abraxane and Avastin for his type of cancer. (Def. 56.1 Resp. ¶ 28.) In MRI's review, the peer review physician stated that "the preferred approach to biliary obstruction is percutaneous transphepatic radiologic catheter bypass or endoscopically placed stents" and that "[s]tandard chemotherapy is usually not effective, though occasional patients might be palliated." (Pl. 56.1 Resp. ¶ 14; Def. 56.1 Exhibit 3, Ex. A pp. 6-7.) The physician noted that "[a] search in the PDQ [National Cancer Institute's Physician Data Query] website entered both drug names showed 4 clinical trials for Avastin, none for Abraxane and none for the combination of both drugs." (Pl. 56.1 Resp. ¶ 14.) The physician concluded that "Abraxane and Avastin are not considered medically necessary for the treatment of this condition in this particular setting." (Pl. 56.1 Resp. ¶ 14.) According to MRI's review, the peer review physician was board certified in internal medicine by the American Board of Internal Medicine, Hematology and Medical Oncology and was a member of the American Society of Clinical Oncology and the American Society of Hematology. (Pl. 56.1 Resp. ¶ 14.)

2. November 21, 2007 Denial of Benefits Letter

Guardian sent a letter to Jacobs on November 21, 2007 denying benefits for the Avastin and Abraxane regimen and noting that there were no approved clinical trials testing the use of an Avastin and Abraxane combination for his diagnosis. (Pl. 56.1 Resp. ¶ 15; Def. 56.1 Resp. ¶ 25.) The letter further informed Jacobs that an independent peer reviewer had concluded that that this combination was experimental and not medically necessary, but did not provide the identity of that reviewer. (Pl. 56.1 Resp. ¶ 15; Def. 56.1 Resp. ¶ 25.) The letter explained that "[e]xperimental treatment and those determined to not be medically necessary are not a covered benefit under your plan." (Def. 56.1 Resp. ¶ 25; Amend. Compt., Exhibit E.) The letter informed Jacobs that he had a right to appeal the claim denial and should submit any supporting documentation with his appeal. (Pl. 56.1 Resp. ¶ 15.) Finally, the letter specified that "[u]pon request and free of charge you are entitled to receive... copies of... guidelines, documents, records, clinical review criteria and all other information pertaining to this determination." (Pl. 56.1 Resp. ¶ 15; Amend. Compt., Exhibit E.) Neither Guardian nor MRI consulted with Jacobs' treating physician about the medical necessity or experimental nature of the Abraxane and Avastin treatment. (Def. 56.1 Resp. ¶ 28.)

3. December 7, 2007 Peer Review Report by MCMC

On December 7, 2007, Guardian sought an additional review of the Abraxane and Avastin regimen from MCMC, a peer review analysis company. (Pl. 56.1 Resp. ¶ 16; Def. 56.1 Resp. ¶ 30.) Dr. Sujith R. Kalmadi ("Dr. Kalmadi"), a board certified specialist in Internal Medicine-Medical Oncology, performed the review. Dr. Kalmadi concluded that:

The use of Abraxane/Avastin is not being provided as part of an approved clinical trial. This is being provided as off label use of these drugs.... Given the member's diagnosis the use of Abraxane and Avastin is an investigational cancer treatment. It does not have approval by the Food and Drug Administration (FDA), compendium listed, randomized control trials, or expert consensus.... The use of Abraxane and Avastin is not medically necessary for this member, as this has not been shown to be beneficial in randomized control trials. (Pl. 56.1 Resp. ¶ 16.) The report further stated that this particular combination has not been shown beneficial in any published peer review literature of clinical trials. (Pl. 56.1 Resp. ¶ 16.) Guardian then continued to deny Jacobs' claims involving the combination of Abraxane and Avastin, explaining that MCMC maintained that they were not part of a clinical trial and thus were considered investigational and not medically necessary. (Def. 56.1 Resp. ¶ 31.)

4. December 26, 2007 Appeal Letter by University Medical Center

The University Medical Center in Tuscon sent an appeal letter on behalf of Jacobs on December 26, 2007, enclosing Jacobs' medical records, literature in support of his treatment regimens, and a copy of an email from Tomislav Dragovich ("Dragovich") to Wendalyn Andrews ("Andrews"), the Director of Oncology Services at the University Medical Center. (Pl. 56.1 Resp. ¶ 17.) In that email, Dragovich stated: "there is not much, a case report and phase I study. I think the driving point should be that beyond [sic] there are no approved and known effective treatments for this disease and he is still strong to tolerate therapy and he is responding to this therapy." (Pl. 56.1 Resp. ¶ 17; Def. 56.1, Exhibit 3, Ex. A, p. 13.)

5. January 15, 2008 Peer Review Report by MCMC

On January 15, 2008, Guardian sought an appeal review by MCMC, and Dr. Robert Marciniak ("Dr. Marciniak"), who is M.D. board certified in internal medicine and medical oncology, reviewed the documents submitted. (Pl. 56.1 Resp. ¶ 18; Def. 56.1 Resp. ¶ 30.) He concluded that because "there are no peer-reviewed published clinical studies of the combination of Abraxane/Avastin as a treatment for advanced cholangiocarcinoma,... it would be considered investigational and of unproved benefit. As it is of unproven benefit, it would not be considered medically necessary for this patient." (Pl. 56.1 Resp. ¶ 18; Def. 56.1 Exhibit 3, Ex. A, p. 15.) Dr. Marciniak noted that there were no studies of Avastin or Abraxane as monotherapy for cholangiocarcinoma and that the reference provided by Jacobs' treating physician was not a trial of Abraxane and Avastin, but was a phase I trial of Abraxane and Carboplatin. (Pl. 56.1 Resp. ¶ 18.) The materials provided to MCMC reviewers did not include any statements from Jacobs' treating physician about the efficacy of the treatment of Abraxane and Avastin being provided to Jacobs. (Def. 56.1 Resp. ¶ 30; Pl. 56.1 Exhibit 3; p.135: 9-16.)

6. June 2, 2008 Request for Reconsideration

On June 2, 2008, Jacobs' treating physician wrote to Guardian requesting that it reconsider its decision to deny coverage, explaining that under the Avastin and Abraxane treatment, Jacobs had experienced an objective and sustained tumor response with tumor marker reduction and PET-CT improvement. (Def. 56.1 Resp. ¶ 32.) The letter further stated that the treatment regimen had been beneficial to Jacobs. (Def. 56.1 Resp. ¶ 32.)

7. September 30, 2008 and December 4, 2008 Denial of Benefits Letters

On September 30, 2008 and December 4, 2008, Guardian again denied coverage for Jacobs' treatment, explaining that an "independent physician consultant determined that treatment with Abraxane plus Avastin was not provided as part of an approved clinical trial, would be considered an investigational treatment for the member's diagnosis and would not be considered medically necessary for this member." (Def. 56.1 Resp. ¶ 33.) These denials were based on the November 13, 2007, December 7, 2007, and January 15, 2008 reviews that Guardian requested from its independent reviewers. (Def. 56.1 Resp. ¶ 34.) In its September 30, 2008 and December 4, 2008 letters denying coverage, Guardian did not respond to many of the specific concerns voiced in the letter of Jacobs' treating physician. (Def. 56.1 Resp. ¶ 33.) The letters also did not identify any specific Policy provision, internal rule, guideline or protocol relied upon in denying the claims. (Def. 56.1 Resp. ¶ 34.) The letters, however, stated that "[u]pon request and free of charge you are entitled to receive reasonable access to, and copies of, these guidelines, documents, records, clinical review criteria and all other information pertaining to this determination." (Def. 56.1 Resp. ¶ 34; Amend. Cmplt, Exhibit G.)

8. January 19, 2009 Peer Review Report by MRI

In September 2008, Jacobs' treating physician began treating him with chemotherapy consisting of a single use of Avastin or Abraxane and Jacobs submitted those claims to Guardian. (Def. 56.1 Resp. ¶ 35.) On January 19, 2009, MRI sent Guardian an independent peer review report about the status of a single use of Avastin as a treatment regimen for Jacobs' cancer. (Pl. 56.1 Resp. ¶ 20.) The physician who conducted the review was Acting Chief of Hematology/Oncology at a university hospital, board certified in oncology and hematology, and a member of the American Society of Clinical Oncology. (Pl. 56.1 Resp. ¶ 20.) The peer review physician concluded in that report that the use of Avastin was not medically necessary because no credible medical literature showed that a second line chemotherapy or maintenance treatment would be beneficial for the treatment of Jacobs' cancer. (Pl. 56.1 Resp. ¶ 20.) Although the physician stated that Avastin is being studied in various phase II studies, the report concluded that ...


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