1 2 3 4 5 6 7 8 9 UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA
LOREN SWEARINGEN, Case No. 2:20-cv-02052-MCS-JEM Plaintiff, FINDINGS OF FACT AND 15 y CONCLUSION OF LAW WESTLAKE HEALTH CARE PLAN; 7 | BEBE GRORS BLE AMER 18 || BLUE CROSS BLUE SHIELD, 19 Defendants. 20 71 Plaintiff Loren Swearingen brings this action under the Employment 22 || Retirement Income Security Act of 1974 (“ERISA”) against Defendant Blue Cross 23 || Blue Shield of Georgia, Inc. dba Anthem Blue Cross Blue Shield (“Anthem”) 74 || alleging he was wrongfully denied his request for Proton Beam Radiation Therapy 25 || (‘PBRT”) under the terms of the Westlake Health Care Plan (“Plan”), which is a self- 26 || insured employee benefit plan. After reviewing the administrative record (“AR”) and 27 || considering the parties’ trial briefs, the Court makes the following findings of facts 28 || and conclusions of law.
1 I. FINDINGS OF FACT* 2 Plaintiff's Claim and Appeal 3 In November 2017, Plaintiff was a 63-year-old man diagnosed with high- 4 || volume, high-risk prostate cancer with accompanying urinary symptoms and 5 || erectile dysfunction. AR110; 134. Plaintiff sought treatment at MD Anderson in 6 || November 2017 and was recommended PBRT by Dr. Seungtaek Choi. AR129-134. 7 || Dr. Choi wrote: “I would recommend proton beam radiation therapy over x-ray 8 || therapy due to recent publications showing a higher cure rate and lower side effect 9 || risks with proton therapy in this healthy 63-year old patient.” AR134. Dr. Choi 10 || claimed PBRT was medically necessary for Plaintiff because it reduced the risk of 11 || creating a radiation-induced malignancy. AR747. On December 4, 2017, MD 12 || Anderson requested benefits for PBRT for Plaintiff and provided procedure codes 13 || and medical records to Anthem. AR128-146. Anthem denied the request on 14 || December 5, 2017, writing that “medical studies we have seen do not show that this 15 || treatment works as well as other treatments for this type of cancer,” claiming that 16 || the treatment is investigational and not medically necessary, and citing its medical 17 || necessity guidelines. AR81. On December 7, 2017, MD Anderson submitted an 18 || appeal on Plaintiff's behalf. AR108. On December 10, 2017, Anthem upheld its 19 || coverage decision and denied the PBRT as experimental/investigational, explaining 20 || that the request had been reviewed by a Physician Reviewer who is board certified 21 || in oncology. AR738. 22 On December 13, 2017, Plaintiff appealed Anthem’s initial denial with Dr. 23 || Choi’s assistance. AR1968-1993. Anthem upheld the denial on January 13, 2018, 24 || noting again that PBRT was investigational and that the appeal had been presented 25 || to the Voluntary Appeal Panel, which determined medical studies do not show that 26 || PBRT works as well as other treatments for prostate cancer. AR738. On February 5, 27 28 || | Any conclusion of law which is deemed a finding of fact is incorporated herein by reference. _2-
1 || 2018, Dr. Choi submitted another appeal on Plaintiff's behalf. AR744-750. Dr. Choi 2 || wrote that PBRT “is the most advantageous treatment for [Plaintiff] as it will limit 3 || excess dose to his bladder, small bowel, rectum and surrounding pelvic tissues, thus 4 || preventing any worsening of his symptoms.” AR744. Dr. Choi explained the 5 || difficulties in obtaining a telephone call with Anthem’s physician to discuss the 6 || treatment and Anthem’s delays in rendering the appeal decision. AR745. Dr. Choi 7 || wrote that the delays by Anthem “ha[ve] led to an absolutely unnecessary delay in 8 || Mr. Swearingen’s care for his life-threatening cancer!” AR745. Dr. Choi contended 9 || that Anthem’s guidelines were outdated, inapplicable, and unsupported by the 10 || medical studies, which he detailed at length. AR746-747. On February 23, 2018, a 11 || third-party external reviewer, Advanced Medical Reviews (“AMR”), wrote to 12 || Plaintiff and noted, “After careful consideration of all relevant medical information, 13 || attending health care professional’s recommendation, appropriate practice 14 || guidelines, applicable criteria sets, standards and interpretative guidelines, and the 15 || terms of the plan, AMR upholds [Anthem’s] decision and the request is denied.” 16 || AM754. 17 AMR provided Plaintiff with its Peer Reviewer Final Report, wherein an 18 || independent medical reviewer reviewed Anthem’s decision. AR3973-3975. The 19 | AMR reviewer considered Plaintiff's medical records, a letter from Dr. Choi, 20 || Anthem’s Medical Policy, and the Plan. AR3973-3975. The AMR reviewer also 21 || considered medical literature submitted with Plaintiff's appeals, including studies 22 || from the Journal of the American Medical Association and the American Society for 23 || Radiation Oncology’s (“ASTRO”) Medical Policy for Proton Radiation. AR3973- 24 || 3975. The AMR reviewer concluded that “proton beam radiation is not medically 25 || necessary for treatment of this patient’s high risk prostate cancer,” explaining: 26 There is insufficient high quality clinical evidence in the 27 peer-reviewed medical literature to make conclusions 38 about the relative safety/efficacy of proton beam radiation _3-
for prostate cancer, as compared to standard of care photon 2 radiation. Withholding proton radiation is not expected to negatively affect the patient’s health, as there are other 3 highly effective and safe options for treatment of his 4 malignancy. As such, based on the evidence-based literature, the proposed treatment is not medically 5 necessary. 6 || AR3973-3974. 7 The AMR reviewer recommended that “[Anthem] should not cover the 8 || proposed treatment.” AR3974. According to the AMR Report, the reviewer “does 9 || not accept compensation for review activities that is dependent in any way on the 10 || specific outcome of the case,” the reviewer “was not involved with the specific 11 || episode of care prior to referral of the case for review,” and the reviewer “does not 12 || have a material professional, familial, or financial conflict of interest” in reviewing 13 || the matter. AR3971. Plaintiff proceeded with Dr. Choi’s recommendation and 14 || completed a course of 39 fractions of PBRT from April 3, 2018 to May 25, 2018 15 || which he paid for out of pocket. AR1183, 2647-2648. On January 24, 2019, Plaintiff 16 || and Dr. Choi appealed the denial of Plaintiff's PBRT on a post-service basis. AR760- 17 || 766. On February 25, 2019, Plaintiff submitted more correspondence claiming that 18 || PBRT enabled him to successfully treat his cancer without missing any work or 19 || experiencing any side effects. AR785-787; 1165. Plaintiff wrote that PBRT satisfies 20 || Anthem’s requirement that the treatment must be “consistent with the standards of 21 || good medical practice which are generally accepted by the medical-scientific 22 || community” because many insurance carriers, Medicare, and the FDA approve 23 || PBRT. AR787. 24 On February 28, 2019, Anthem responded to these appeal letters stating it 25 || would treat them as a standard post-service appeal request. AR1687. On April 26, 26 || 2019, Anthem responded with a first level post-service appeal denial. AR717-718. 27 || Anthem noted the decision had been reviewed by a medical reviewer specializing in 28 -4-
1 || radiation oncology, reasoning that there was insufficient evidence that PBRT 2 || improves health outcomes for prostate cancer and the treatment thus was not 3 || medically necessary. AR717. Anthem referenced the AIM Guidelines and provided 4 || online links to the other medical policies and clinical guidelines. AR717. Plaintiff 5 || emailed Anthem and wrote that “once again none of the points that I raised in the 6 || attached appeal letter were addressed” by Anthem. AR1263. Plaintiff requested that 7 || Anthem address each point raised in his appeal letter, but Anthem did not respond. 8 || AR1267. 9 Plaintiff retained counsel and submitted a voluntary second level post- 10 || service appeal on August 19, 2019. AR702-1193; 637-699. In support of the 11 || appeal, Plaintiff provided a sampling of five medical studies published between 12 || 2016 to 2019 which summarized PBRT outcomes for prostate cancer in 13 || comparison to intensity-modulated radiation therapy (“IMRT”). AR703. On 14 || September 28, 2019, Anthem upheld its denial, explaining that the Grievance 15 || Advisory Panel met on September 27, 2019 to consider the second level appeal. 16 | AR1196. Specifically, a panel of medical professionals relied on the Medical 17 || Policy and medical studies to determine that PBRT did not work as well as other 18 || prostate cancer treatments. AR1252. 19 Relevant Policy Provisions 20 ERISA governs the Plan and Plaintiff's claim for benefits thereunder. Anthem 21 || denied Plaintiff's claims based on the Plan and the Westlake Medical Benefits 22 || Member Handbook (“SPD”). AR1536; 1539. The Plan states: “This Plan as written 23 || herein, together with any amendments to it, constitutes the entire Plan.” AR1653. 24 || Section 2.12 states, in part: “The Claims Administrator is not an insurer of health 25 || benefits under this Plan, is not a fiduciary of the Plan, and does not exercise any of 26 || the discretionary authority and responsibility granted to the Plan Administrator. The 27 || Claims Administrator is not responsible for Plan financing and does not guarantee 28 || the availability of benefits under this Plan, but shall process claims consistent with _5-
1 || both the terms of the Plan, and with generally accepted standards of claim processing 2 || for professional administrators.” AR1539. 3 Section 17.2 states: 4 5 Claims Administrator’s Responsibilities: 6 The Claims Administrator on behalf of the Plan Administrator shall have the authority and responsibility for: 7 a) Interpreting this Plan’s provisions relating to coverage except 8 where the Claims Administrator requests an interpretation or a 9 claimant files an appeal with the Plan Administrator, in which case the Plan Administrator shall interpret the Plan and shall 10 communicate in writing to the Claims Administrator the 11 appropriate interpretation of the Plan; b) Administering the Plan’s claim procedures; 12 c) Processing checks for benefits in accordance with Plan 13 provisions; d) Filing claims with the insurance companies, if any, who issue stop 14 loss insurance policies to the Employer; 15 e) Transmitting and certifying such information as needed by the 16 Plan Administrator to file the annual report under Section 104 (a)(1)(A) of ERISA and Code Section 6039D; and 17 f) Performing all other responsibilities delegated to the Claims 18 Administrator in the instrument appointing the Claims Administrator. 19 | AR1654-1655. The SPD contains the following relevant language: 20 The Claims Administrator on behalf of the Plan Administrator shall have the 21 authority and responsibility for: 22 . . Interpreting this plan’s provisions relating to coverage except 23 where the Claims Administrator requests an interpretation or a 74 claimant files an appeal with the Plan Administrator. In that case, the Plan Administrator shall interpret the plan and _ shall 25 communicate in writing to the Claims Administrator the 2% appropriate interpretation of the plan; 27 Administering the plan’s claim procedures; 28 -6-
Performing all other responsibilities delegated to the Claims 2 Administrator in the instrument appointing the Claims Administrator. 3 4 If you believe you’re entitled to benefits or rights under a plan that have not been provided, you should file a written claim to the 5 Claims Administrator. 6 || AR67-68. 7 The Plan only covers a service that is Clinically Appropriate, which is defined 8 || as a service which meets all of the following criteria: 9 a) Is consistent with the standards of good medical practice which 10 are generally accepted by the medical-scientific community in the United States of America; 1] b) Is consistent with the symptoms or diagnosis of the condition 2 for which services, treatment, or supplies are rendered; Cc) Is not provided solely for the convenience of the patient or 13 Provider; 14 d) — Is necessary for the diagnosis or correction of a condition which is threatening to the life, health or physical wellbeing of the 15 Covered Person, or is the source of extreme physical discomfort; 16 and e) Is not Experimental or investigational, unless it is a part of 17 Approved Clinical Trial. 18 || ARI539. 19 “In the case of a notice of adverse determination,” the Plan requires the Claims 20 || Administrator to provide “specific reasons for any adverse determination of claim, 21 || reference to pertinent Plan provisions, a description of any additional information 22 || necessary to perfect the claim, and a description of the Plan’s review procedures...” 23 || AR1636. The SPD provides that if a claim is denied, the notice must explain any 24 || guideline protocols or other similar criteria used to inform the benefit denial, and if 25 || the denial is based on clinical appropriateness or an experimental treatment exclusion 26 || or limit, an explanation of the issue must be provided or made available upon request. 27 || AR1514. The SPD requires the same on appeal, noting a decision on an appeal should 28 _7-
1 || explain guideline protocols. AR1515. 2 The SPD instructs members to submit appeals and requests for Second Level 3 || Review to the Claims Administrator, noting: 4 In rendering a decision on a second level appeal that is 5 based, in whole or in part, on medical judgment, including a determination of whether a requested benefit is medically 6 necessary and appropriate or experimental/investigative, 7 the appeals department will consult with a health care professional who has appropriate training and experience 8 in the field of medicine involved in the medical judgment. 9 || ARTO. 10 The SPD indicates that Experimental/Investigational treatment is not covered, 11 | and defines “Experimental/Investigational” as: 12 Experimental or investigational treatments, procedures, 13 devices or drugs as determined by the Claims 4 Administrator, except for approved clinical trials. AR39. 15 Medical Necessity Guidelines 16 Plaintiff had access to Anthem’s medical necessity guidelines, which were in 17 effect when Anthem denied Plaintiff's requests. AR81-84, 3713, 1428-1445. 18 Advanced Imaging Clinical Appropriateness Guidelines— Appropriate Use Criteria: 19 Proton Beam Therapy Guidelines (“AIM Guidelines”) that Anthem relied on state: 20 “There has been no demonstration to the superiority of proton beam therapy (PBRT) 21 over other radiation modalities for the treatment of prostate cancer, and should not 22 be used outside the setting of a clinical trial.”” AR3793. Anthem also relied on its 23 Medical Policy THER-RAD.00002 Proton Beam Radiation Therapy (“Medical 24 Policy”), which states: “Proton beam radiation therapy is considered investigational 25 and not medically necessary when criteria are not met and for all other indications, 26 including, but not limited to, the treatment of localized prostate cancer.” AR1428. 27 The Medical Policy cites to findings which conclude that “ASTRO does not support 28 -8-
1 || the routine use of PBRT for prostate cancer” and it “should only be performed within 2 || the context of a prospective clinical trial or registry.” AR1430. The AIM Guidelines 3 || and Medical Policy are updated in an attempt to remain current with developments 4 || in the medical field and the scientific literature. AR3713, 1428-1445. 5 In Dr. Choi’s pre-service appeal letter, he wrote that PBRT “is the most 6 || advantageous treatment for [Plaintiff] as it will limit excess dose to his bladder, small 7 || bowel, rectum and surrounding pelvic tissues, thus preventing any worsening of this 8 || symptoms.” AR744. Dr. Choi continued: 9 I note that of the 123 references cited in the BCBS Medical Policy 10 THER-RAD.00002, Proton Beam Radiation Therapy (last reviewed May 2017), only 22 speak specifically to prostate cancer, and the most 11 recent of those dates back to 2013. Even more concerning, the oldest dates back to 1993. You are using evidence that is nearly 25 years old to make decisions on treatment for Mr. Swearingen’s life-threatening 13 condition! I also note that of the 22 prostate related references, 6 are not 14 relevant to Mr. Swearingen’s case as he has not had a prostatectomy, is over age 60, and his disease is not T3 or T4. For your review, we have 15 provided several recent citations establishing medical necessity of 16 proton beam therapy for prostate cancer. Please see Appendix A. These articles are the foundation of the clinical reason for the selection of 17 proton therapy. 18 | AR745-746. 19 Dr. Choi wrote that PBRT was superior to IMRT for Plaintiff for the following 20 || reasons: 21 1. “TP ]roton beam therapy has been shown to have an 85% 5-year disease- 22 || free success rate in patients such as [Plaintiff], who have high-risk prostate cancer. 23 || This rate is superior to IMRT which only has a 66% disease control rate in this 24 || group.” 25 2. “TO|f importance given [Plaintiff's] urinary symptoms, the proton 26 || beam is able to stop at its target while IMR would go through the prostate and leave 27 || [Plaintiff's] body through the bladder, rectum, and pelvic tissues. [Plaintiffs] 28 _9-
1 || bladder and bowel will be spared from excess radiation dose, leading to less 2 || toxicities than he would experience with IMRT given his particular condition.” 3 3. “Radiation to the bladder and surrounding areas caused by” IMRT “can 4 || cause incontinence. Genitourinary toxicity rates for patients receiving PBRT are 5 || approximately 70%, while those for patients receiving” IMRT “are noted at nearly 6 || 80%. Because [PBRT] affords us the ability to treat [Plaintiffs] tumor itself with a 7 || 35% lower dose to the bladder than that of IMRT, we are able avoid worsening 8 || [Plaintiffs] already moderate urinary complications.” 9 4. PBRT reduces risk of impotence and radiation could worsen Plaintiff’ s 10 || erectile dysfunction. 11 5. “IMRT unnecessarily irradiates the pelvis while [PBRT] limits exit 12 || doses to almost none. Grade 3 gastrointestinal (GI) toxicity rates with conventional 13 || IMRT are six (6) times that of [PBRT], which has a baseline rate of 1%. Multiple 14 || peer-reviewed prospective studies have found that [PBRT] reduces the risk of 15 || gastrointestinal side effects, such as rectal bleeding and incontinence of stools, in 16 || comparison to” IMRT and other radiation therapies because PBRT “decreases the 17 || radiation dose to gastrointestinal structures by at least 59%. [PBRT] will allow us to 18 || provide adequate coverage to [Plaintiffs] prostate and seminal vesicles to eradicate 19 || the cancer, while eliminating the excess radiation which would in turn be received 20 || by the surrounding healthy tissues if treated with IMRT, leading to adverse 21 || outcomes.” 22 6. “IMRT would cause the delivery... of unnecessary radiation to areas 23 || of [Plaintiff's] normal, health, cancer-free tissue that he would not receive from” 24 || PBRT. The “excess radiation delivery areas of his healthy bladder, rectum, and 25 || surrounding healthy tissue via IMRT is equivalent to the amount of radiation 26 || distributed by five million+ (5,000,000+) dental x-rays.” Plaintiff is “at risk for 27 || secondary malignancies such as rectal and bladder cancer associated with radiation 28 || therapy. Current literature supports [PBRT] over IMRT for the treatment of prostate -10-
1 || adenocarcinoma because [PBRT] has been shown to decrease secondary 2 || malignancies by 26%.” 3 || AR745-747. 4 II. CONCLUSIONS OF LAW? 5 A. Standard of Review 6 The court reviews challenges to an ERISA plan’s denial of benefits de novo 7 | “unless the benefit plan gives the administrator or fiduciary discretionary authority 8 | to determine eligibility for benefits or to construe the terms of the plan.” Firestone 9 || Tire & Rubber Co. v. Bruch, 489 U.S. 101, 115 (1989). Where such discretion is 10 |) vested in the administrator, a district court reviews the administrator’s determinations 11 }) for an abuse of discretion. Nord v. Black & Decker Disability Plan, 356 F.3d 1008, 12 | 1010 (9th Cir. 2004) (“[W]here, as here, a plan administrator has ‘discretionary 13 authority to determine eligibility for benefits,’ we review the benefits decision for 14 | abuse of discretion”). ERISA allows fiduciaries to delegate responsibilities through 15 procedures in the plan. 29 U.S.C. § 1105(c)(1). When an entity other than the plan 16 || administrator makes a benefit determination under an ERISA plan, the standard of 17 |) review depends “on whether the... Plan contemplated the possibility of a transfer of 18 discretionary authority to a third-party and whether there [is] evidence establishing 19 | delegation...” Shane v. Albertson’s Inc., 504 F.3d 1166, 1171 (9th Cir. 2007). 20 Anthem relies on terms in the SPD and Plan to establish that it maintained 21 |) discretion to determine Plaintiff's entitlement to benefits. The parties disagree on 22 || whether the SPD can delegate discretionary authority to Anthem: Plaintiff claims that 23 || the SPD summarizes the Plan and cannot add new terms, while Anthem claims the 24 | SPD is a Plan document with enforceable terms. In CIGNA Corp. v. Amara, the 25 Supreme Court concluded that “summary documents, important as they are, provide 26 || communication with beneficiaries about the plan, but that their statements do not 27 28 |) 2 Any finding of fact which is deemed a conclusion of law is incorporated herein by reference. -ll-
1 || themselves constitute the terms of the plan...” 564 U.S. 421, 438 (2011) (emphasis 2 || in original). In Mull for Mull v. Motion Picture Indus. Health Plan, 865 F.3d 1207, 3 || 1210 (9th Cir. 2017), the Ninth Circuit clarified: 4 Amara addressed only the circumstance where both a governing plan 5 document and an SPD existed, and the plan administrator sought to enforce the SPD’s terms over those of the plan document... 6 Accordingly, an SPD may constitute a formal plan document, 7 consistent with Amara, so long as the SPD neither adds to nor contradicts the terms of existing Plan documents. Here, the SPD is part 8 of the plan itself, and there is no conflict between the SPD and the Trust 9 Agreement. Amara does not prohibit this type of arrangement. 10 Here, the Court considers the SPD as a Plan document because its terms do not 1] || conflict with the Plan. /d.; see also Langlois v. Metro. Life Ins. Co., 833 F. Supp. 2d 12 || 1182, 1185 (N.D. Cal. 2011) “However, the Court does not read Amara to preclude 13 || any reliance on the SPD in determining whether the plan administrator has discretion 14 || to deny benefits.”) (citing Bergt v. Ret. Plan for Pilots Employed by MarkAir, Inc., 15 || 293 F.3d 1139, 1143 (9th Cir. 2002)). The Plan documents give Westlake 16 || discretionary authority as fiduciary and Anthem the delegated discretionary authority 17 || as Claims Administrator. Jordan v. Northrop Grumman Corp. Welfare Benefit Plan, 18 || 370 F.3d 869, 874 (9th Cir. 2004) (applying abuse of discretion standard when 19 || ERISA plan “unambiguously confers discretion on the administrator”). Namely, the 209 || Plan states that Anthem, as Claims Administrator, shall interpret the Plan’s 21 || provisions related to coverage, administer the Plan’s claim procedures, and perform 37 || all other responsibilities delegated to it. AR1654-1655. The SPD states that Anthem, 73 || on behalf of Westlake, has the “authority and responsibility” to interpret the “Plan’s 24 || provisions relating to coverage,” and to perform “all other responsibilities delegated 25 || to the Claims Administrator” in the Plan. AR67. The SPD further indicates that 26 || Anthem has discretion to determine whether a treatment is medically necessary. 27 || AR70. Plaintiffs cited Plan terms do not undercut the delegation of authority to 2g || Westlake as fiduciary and delegation of distinct authority—.e. medical necessity -]2-
1 || determinations—to Anthem as Claims Administrator. For example, the Plan provides 2 || that the “Claims Administrator... is not a fiduciary of the Plan, and does not exercise 3 || any of the discretionary authority and responsibility granted to the Plan 4 || Administrator. The Claims Administrator is not responsible for Plan financing and 5 || does not guarantee the availability of benefits under this Plan, but shall process claims 6 || consistent with both the terms of the Plan, and with generally accepted standards of 7 || claim processing for professional administrators.” AR1539. This language does not 8 || foreclose Anthem’s authority to make coverage determinations delegated to it in the 9 || SPD—the SPD delineates distinct duties between the fiduciary and the claims 10 || administrator. Because the Plan documents demonstrate that Anthem maintained 11 || discretion as to Plaintiffs entitlement to benefits, the Court reviews Anthem’s denial 12 || for abuse of discretion. Metro. Life Ins. Co. v. Glenn, 554 U.S. 105 (2008). 13 B. Anthem’s Alleged Conflict of Interest 14 Even where a court reviews an administrator’s benefit determination for abuse 15 || of discretion, it should consider the “nature, extent, and effect on the decision-making 16 || process of any conflict of interest that may appear in the record.” Abatie v. Alta 17 || Health & Life Ins. Co., 458 F.3d 955, 967 (9th Cir. 2006). Plaintiff argues that 18 || Anthem operated under a conflict of interest because it applied “outdated □□□□□□□□□□□ 19 || and did not consider the most current medical studies applicable to □□□□□□□□□□□ 20 || condition. These aversions do not satisfy Plaintiff's burden. Demer v. IBM Corp. 21 || LTD Plan, 835 F.3d 893, 902 (9th Cir. 2016) (“It is [plaintiff's] burden, as the party 22 || claiming a conflict, to produce evidence of a financial conflict sufficient to warrant 23 || a degree of skepticism.”). Because Anthem was neither the plan administrator nor 24 |) the benefits’ funding source, a conflict of interest is unlikely. James v. AT & T W. 25 || Disability Benefits Program, 41 F. Supp. 3d 849, 873 (N.D. Cal. 2014) (“Where the 26 || party that must pay the benefits and the party that administers the benefits are not the 27 || same, there is little risk, if any, of a conflict of interest.”) (citing Metro. Life Ins. Co., 28 || 554 U.S. at 108). That Anthem allegedly consulted the wrong studies to assess -13-
1 || Plaintiff's claim is not persuasive evidence of a conflict and nothing in record 2 || suggests a financial conflict or procedural irregularity that could impact the standard 3 || of review. Ekno v. Nw. Mut. Life Ins. Co., 2008 WL 782728, at *6 (E.D. Cal. Mar. 4 | 20, 2008) (“Therefore, because there is no evidence before the court of a 5 || serious conflict of interest, nor is there evidence of a wholesale or flagrant violation 6 || of ERISA’s procedural requirements or the Plan’s claims handling procedures, the 7 || court concludes that de novo review of NWML’s decision to deny LTD benefits is 8 || improper.”) (citing Abatie, 458 F.3d at 971) (noting that procedural irregularities 9 || must be “wholesale and flagrant violations” to alter the standard of review)). 10 C. Whether Anthem Abused Its Discretion 11 “A plan administrator abuses its discretion under ERISA where its decision is 12 || “(1) illogical, (2) implausible, or (3) without support in inferences that may be drawn 13 || from facts in the record.’” Howard v. Blue Cross Blue Shield of Arizona, 822 F. 14 |} App’x 628, 629 (9th Cir. 2020) (citation omitted). An administrator’s decision will 15 || not be disturbed if it is the “result of a deliberate, principled reasoning process and if 16 || it is supported by substantial evidence.” Glenn v. MetLife, 461 F.3d 660, 666 (6th 17 || Cir. 2006), aff'd sub nom. Metro. Life Ins. Co., 554 U.S. 105. Plaintiff bears the 18 || burden of establishing that Anthem abused its discretion. Baxter v. MBA Grp. Ins. 19 | Tr. Health & Welfare Plan, 958 F. Supp. 2d 1223, 1230 (W.D. Wash. 2013) 20 || (“Plaintiff bears the burden of showing that proton therapy was a medically necessary 21 || treatment for his disease.”). 22 The Ninth Circuit recently affirmed denial of benefits where Blue Cross Blue 23 || Shield of Arizona (““BCBSAz’) declined to cover plaintiff's PBRT as investigational 24 || and not medically necessary. Howard, 822 F. App’x at 629. The court held that: (1) 25 || BCBSAz did not abuse its discretion because it did not rely on clearly erroneous 26 || findings of fact, (2) there was no conflict of interest in BCBSAz’s control of THER- 27 || RAD.00001, and (3) BCBSAz had no control over Advanced Imaging Clinical 28 || Appropriateness Guidelines — Appropriate Use Criteria: Imaging of the Brain. /d. -14-
1 Howard involved the same doctor (Dr. Choi), same medical facility, same 2 || treatment, and same approximate grounds for denial as this case. Plaintiffnonetheless 3 || contends that the result should be different here because Anthem allegedly ignored 4 || Plan terms when it relied on medical necessity guidelines to deny Plaintiff's claim. 5 || Plaintiff also stresses that the final denial in Howard was roughly four years before 6 || the final denial in this case, and that his proffered medical studies were published 7 || after Howard’s final denial. Similar arguments were rejected in Howard. See Howard 8 || v. Blue Cross Blue Shield of Arizona, 2019 WL 3068202, at *4 (D. Ariz. July 12, 9 || 2019), aff'd, 822 F. App’x 628 (9th Cir. 2020) (rejecting argument that “Defendant 10 || should not have relied on an outdated MCG which in turn relied on studies that failed 11 || to take into account recent science on PBRT” because plaintiff offered “no evidence 12 || that the MCG on which Defendant relied was ‘clearly erroneous.’’’); see also id. 13 || (rejecting argument “that Defendant abused its discretion by failing to take into 14 || account the opinions of Plaintiffs treating oncologists and instead relying on 15 || independent reviewing doctors who do not specialize in oncology.”). 16 This Court likewise rejects Plaintiff's proffered medical records and assertion 17 || that PBRT is commonly used as evidence that Anthem’s guidelines were erroneous. 18 || /d. (finding that plaintiff's medical studies and “assertion that PBRT is becoming 19 || more widely used” did not establish that guidelines were clearly erroneous). As 20 || Anthem notes, Plaintiff inconsistently criticizes Anthem’s reliance on “outdated” 21 || studies from 2017 while pointing the Court to even older studies. In any event, it is 22 || not the Court’s role to determine which medical opinion should prevail. Woodruff v. 23 || Blue Cross & Blue Shield of Alabama, 2018 WL 571933, at *7 (N.D. Ala. Jan. 26, 24 || 2018) (“[T]he proper interpretation of medical research studies is not before this 25 || court. Rather, the sole issue is whether BCBS’s decision denying coverage for PBRT 26 || was supported by the language of the Plan based on the information before the 27 || administrator at the time the decision was made.”’). Despite long-standing industry 28 || variance, courts consistently confirm the propriety of analogous denials of PBRT -15-
1 || treatment. /d. (“Given the demonstrated lack of agreement in the medical community 2 || as to the proper role of PBRT treatment, the Plan’s recognition of this lack of 3 || agreement, the clear statement in Medical Policy #348 that PBRT for prostate cancer 4 || is not a covered service, and the multiple reviews of its decision undertaken by the 5 || Plan, the denial of benefits here was neither arbitrary nor capricious.”); Turner v. 6 || Alcoa, Inc., 2016 WL 8257672, at *2 (E.D. Tenn. Dec. 29, 2016) (finding that 7 || administrator did not abuse its discretion in applying internal medical guidelines 8 || which stated: “AIl other applications or uses of PBRT [including as treatment for 9 || prostate cancer] are considered experimental/investigational and ineligible for 10 || payment. Currently published medical literature does not provide sufficient 11 || documentation to permit conclusions concerning the effect on health outcomes. This 12 || modality remains an area of research.”); Dillon v. Timken Co., 2013 WL 4508975, at 13 | *3 (W.D. Pa. Aug. 26, 2013) (finding that the evidence “overwhelmingly” 14 || established no abuse of discretion in finding that PBRT for prostate cancer was 15 || experimental); Gardner v. Group Health Plan, 2011 WL 1321403, at *4 (E.D.N.C. 16 || Apr. 4, 2011) (granting “summary judgment as the Plan clearly excludes [PBRT] as 17 || experimental and there is no issue of material fact regarding whether Defendant 18 || abused its discretion in denying benefits”). Plaintiffs insistence that recent literature 19 || runs contrary to these denials does not allow the Court to ignore controlling Ninth 20 |) Circuit authority or weigh the merits of an ostensibly ongoing medical debate. 21 Plaintiff's argument that Anthem’s denials ignored Plan terms contradicts the 22 || record, which demonstrates that Anthem complied with the Plan by relying on its 23 || guidelines and providing Plaintiff adequate notice of same. The Plan and the SPD 24 || provide that experimental or investigational treatment is not covered. AR39, 1539. 25 || “In the case of a notice of adverse determination,” the Plan requires the Claims 26 || Administrator to provide “specific reasons for any adverse determination of claim, 27 || reference to pertinent Plan provisions, a description of any additional information 28 || necessary to perfect the claim, and a description of the Plan’s review procedures...” -16-
1 || AR1636. Ifa claim is denied, the notice must explain any guideline protocols or other 2 || similar criteria used to inform the benefit denial, and if the denial is based on clinical 3 || appropriateness or an experimental treatment exclusion or limit, an explanation of 4 || the issue must be provided or made available upon request. AR1514. Anthem 5 || complied with these requirements by informing Plaintiff that his request was denied 6 || as “investigational and not medically necessary” under the Plan and consistent with 7 || supporting criteria available to Plaintiff. AR1196-1197, 1252. 8 Like the record in Howard, the record here provides enough support for 9 || Anthem to find that PBRT was not medically necessary to treat Plaintiff's prostate 10 || cancer relative to traditional treatments with known safety, efficacy, and quality of 11 || life outcomes. Turner v. Alcoa, Inc., 2017 WL 627447, at *2 (E.D. Tenn. Feb. 15, 12 || 2017) (“That courts were still upholding the denial of coverage for the procedure as 13 || experimental at the time [the defendant] made its determination supports the 14 || conclusion that the decision was not arbitrary and capricious.”) (quoting Peruzzi v. 15 || Summa Med. Plan, 137 F.3d 431 (6th Cir. 1998)). Four physician reviewers provided 16 || substantial evidence that supported Anthem’s determination. Howard, 822 F. App’x 17 || at 629 (citing Woodruff, 2018 WL 571933, at *7 (finding that independent experts’ 18 || decision to uphold denial of coverage supported determination that PBRT for prostate 19 || cancer was experimental); Turner, 2016 WL 8257672, at *8 (same); Dillon, 2013 20 | WL 4508975, at *2 (same)). Then-existing guidelines noting the insufficient 21 || evidence concerning PBRT’s health impacts bolstered Anthem’s determination, as 22 || did the aforementioned legal authorities holding that PBRT was experimental and 23 || not medically necessary for prostate cancer. Despite Plaintiff's contrary assertions, 24 || the Court cannot find that Anthem abused its discretion by relying on four physician 25 || reviewers and its guidelines instead of Dr. Choi. Howard, 2019 WL 3068202, at *4 26 || (‘The Court declines to find that reliance on two licensed doctors of internal 27 || medicine, rather than an oncologist, leads to a clearly erroneous finding of □□□□□□□□□ 28 Bound by Howard, the Court finds that the record evidences a reasonable -17-
1 || review and proper reliance on then-existing policies, guidelines, and literature as 2 || required by the Plan. Anthem’s determination that the Plan did not cover Plaintiff's 3 || PBRT was not an abuse of discretion. 4 I. CONCLUSION 5 Judgment shall be entered in Anthem’s favor consistent herewith. 6 7 || Dated: August 24, 2021 4, By: ake L beare: 9 Mark C, Scarsi 10 United States District Court Judge 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28