Case 2:21-cv-01422-MTL Document 1 Filed 08/17/21 Page 1 of 17
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`
`Glenn R. Kantor, California State Bar No. 122643
`KANTOR & KANTOR, LLP
`19839 Nordhoff Street
`Northridge, California 91324
`Telephone: (818) 886-2525
`gkantor@kantorlaw.net
`
`Appearing Pro Hac Vice
`
`Attorneys for Plaintiff
`Rebecca Bartee
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF ARIZONA
`No.
`
`REBECCA BARTEE,
`
`Plaintiff,
`
`v.
`
`BANNER HEALTH AND AETNA
`HEALTH INSURANCE COMPANY,
`
`Defendant.
`
`COMPLAINT
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`For her claims against Banner Health and Aetna Health Insurance Company
`(“Aetna”), Plaintiff Rebecca Bartee (“Ms. Bartee” or “Plaintiff”) alleges as follows:
`Jurisdiction, Venue And Parties
`1. This action arises under the Employee Retirement Income Security Act of
`1974, 29 U.S.C. §§ 1001 et seq. (“ERISA”).
`2. Plaintiff Rebecca Bartee is a resident of Surprise, Arizona in Maricopa
`County in the State of Arizona.
`3. Plaintiff was at all relevant times a participant under the Aetna Preferred
`Provider Organization (PPO) Medical Plan (“Plan”) (Member ID#: 240535857), a
`welfare benefit plan regulated by ERISA.
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`COMPLAINT
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`Northridge, California 91324
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`19839 Nordhoff Street
`KANTOR & KANTOR LLP
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`(818) 886 2525
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`

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`Case 2:21-cv-01422-MTL Document 1 Filed 08/17/21 Page 2 of 17
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`4. Aetna administered benefit claims under the Plan.
`5. Plaintiff is informed and believes that Aetna, the claims administrator, is a
`plan fiduciary doing business in the State of Arizona, is authorized to transact and
`transacts business in the State of Arizona, and can be found in the State of Arizona.
`6. Defendant can be found in this judicial district and the Plan is administered in
`this judicial district.
`7. This Court has jurisdiction over the subject matter of this action under ERISA,
`29 U.S.C. §§ 1132(a), 1132(e)(1), and 28 U.S.C. §§ 2201-02 (declaratory judgments).
`8. Venue is proper in this Court under ERISA, 29 U.S.C. § 1132(e)(2) and 28
`U.S.C. § 1391(b).
`Introduction and Background of Proton Beam Radiation Therapy
`Proton beam radiation therapy (“PBRT” or “proton therapy”) has been
`9.
`recognized for decades by the medical community as an established, medically
`appropriate treatment for cancer, including head and neck cancers.
`The first hospital-based proton-beam center in the United States was at the
`10.
`Loma Linda University Medical Center, which began operation in 1990.
`Through local coverage determinations or the guidelines adopted by
`11.
`various Medicare Advantage organizations (MAOs), Medicare generally covers PBRT
`for high-grade (WHO grade III) anaplastic oligodendroglioma (“high-grade brain
`glioma”).
`12.
`cancer.
`PBRT destroys cancer cells by preventing them from dividing and
`13.
`growing, like conventional X-ray radiation.
`The difference between PBRT and conventional X-ray radiation is that
`14.
`protons deposit much of their radiation directly in the tumor and then stop.
`That allows patients to receive higher doses, which can be more effective,
`15.
`while reducing damage to healthy tissues that surround the tumor.
`
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`PBRT is the most effective form of radiation therapy for many types of
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`COMPLAINT
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`Northridge, California 91324
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`19839 Nordhoff Street
`KANTOR & KANTOR LLP
`
`(818) 886 2525
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`Case 2:21-cv-01422-MTL Document 1 Filed 08/17/21 Page 3 of 17
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`The physical properties of protons are different from the physical
`16.
`properties of X-rays.
`Protons are large, positively charged sub-atomic particles that penetrate
`17.
`matter to a finite depth.
`18. X-rays are electromagnetic radiation that penetrate completely through
`tissue.
`Protons can be conformed to release much of their energy at precise depths
`19.
`so they can target tumors inside the body, depositing much of their radiation exactly at
`the tumor site.
`20. X-rays release their maximum dose of radiation quickly after penetrating
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`the skin, damaging healthy tissue and organs on their way to the tumor and again as they
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`pass through the body beyond the tumor.
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`The goal of treatment is to deliver the proper dose of radiation to the tumor
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`while limiting the dose received by the surrounding healthy tissue.
`To deposit the proper amount of energy into the tumor, X-rays must
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`irradiate much of the healthy tissue in front of it, known as an “entrance dose,” and then
`continue to penetrate through the tumor and irradiate much of the healthy tissue behind
`it, known as an “exit dose.”
`To deliver the proper dose to a tumor, a radiation oncologist must “work
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`around” the tumor by using multiple X-ray beams, delivering the highest dose where the
`beams intersect, but delivering low to medium “entrance” and “exit” doses to
`surrounding healthy tissue. In contrast, protons enter the patient at a low dose, then, at a
`precise depth, they deliver a large burst of energy. Immediately after this burst, they stop
`completely. To treat the entire tumor, additional protons are sent in at lower doses. In
`this way, protons completely irradiate the tumor while limiting the dose to the nearby
`healthy tissue.
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`COMPLAINT
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`Northridge, California 91324
`
`19839 Nordhoff Street
`KANTOR & KANTOR LLP
`
`(818) 886 2525
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`

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`Case 2:21-cv-01422-MTL Document 1 Filed 08/17/21 Page 4 of 17
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`Proton treatment delivers a dose in a more accurate way, a more efficient
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`way, and spares more of the surrounding healthy tissue.
`Since protons have a low “entrance dose” and essentially no “exit dose,”
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`the volume of normal tissue receiving radiation with PBRT is typically reduced by a
`factor of 2-3 when compared to even the most modern X-ray treatment plan.
`Proton therapy is the most effective form of treatment for high-grade brain
`26.
`gliomas because it minimizes the radiation dose to vital bodily organs and functions,
`such as the gastrointestinal system or urinary tract. Many respected cancer facilities and
`providers, including but not limited to, MD Anderson at the University of Texas,
`Harvard Medical School/Massachusetts General Hospital, Northwestern University,
`Baptist Hospital’s Miami Cancer Institute, Loma Linda University, University of
`Florida, University of Maryland, Mayo Clinic, Emory University, Case Western Reserve
`University, Washington University in St. Louis, University of Washington, New York
`Proton Center, and the Texas Center for Proton Therapy recommend and use PBRT on a
`regular basis.
`The medical community has found proton beam therapy radiation
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`treatment to be a generally accepted standard of medical practice for the treatment of
`high-grade brain gliomas.
`28. Other insurers, including Medicare, cover PBRT as a safe and effective
`treatment that is not “investigational.”
`There is overwhelming evidence that PBRT is safe and effective.
`29.
`30.
`PBRT is a generally accepted standard of medical practice for the
`treatment of cancer, including high-grade brain gliomas, within the medical community.
`PBRT has been around and well-accepted for over 30 years.
`31.
`32.
`The Food and Drug Administration (“FDA”) approved PBRT in 1988 with
`the following specific statement of indications for intended use: “The [Proton Therapy
`System] is a medical device designed to produce and deliver proton beam for the
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`COMPLAINT
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`Northridge, California 91324
`
`19839 Nordhoff Street
`KANTOR & KANTOR LLP
`
`(818) 886 2525
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`

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`Case 2:21-cv-01422-MTL Document 1 Filed 08/17/21 Page 5 of 17
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`treatment of patients with localized tumors and other conditions susceptible to treatment
`by radiation.”
`The American Society for Radiation Oncology (ASTRO), the National
`33.
`Comprehensive Cancer Network (NCCN), and other nationally-recognized medical
`organizations have validated the safety and effectiveness of PBRT.
`34. Numerous peer-reviewed studies have validated the safety and
`effectiveness of PBRT.
`35.
`There is randomized Level I dual-institutional trial evidence to support
`the use of proton therapy for high-grade brain gliomas.
`36.
`This also sets proton therapy apart from conventional X-ray radiation,
`as historically the radiation oncology field has not performed many randomized
`trials testing whether or not one technology is better than another.
`37. Because radiation therapy is based on well understood principles of
`physics, a randomized trial is not necessary to know whether or not more energy
`will be deposited into healthy tissue with X-rays than with proton therapy.
`38.
`That X-rays will irradiate more surrounding healthy tissue than proton
`therapy is a scientific fact.
`39.
`Instead, the field is interested in whether or not more energy can be
`delivered to the tumor and less to healthy tissue.
`40.
`In contrast, there is no randomized data or prospective data to support
`the use of X-ray radiation to treat high-grade brain gliomas, the default fallback to
`which Aetna has forced its subscribers to resort by virtue of its systematic denial of
`PBRT for the treatment of high-grade brain gliomas.
`The medical community has found PBRT treatment to be both medically
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`necessary and a superior form of treatment than established alternative treatments for the
`treatment of high-grade brain gliomas.
`42. Most importantly, Plaintiff’s treating provider, Dr. Sujay Vora of Mayo
`found PBRT to be the best form of treatment for Plaintiff.
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`COMPLAINT
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`Northridge, California 91324
`
`19839 Nordhoff Street
`KANTOR & KANTOR LLP
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`(818) 886 2525
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`Case 2:21-cv-01422-MTL Document 1 Filed 08/17/21 Page 6 of 17
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`General Allegations
`Plaintiff incorporates by reference all preceding paragraphs as though fully
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`set forth herein.
`Plaintiff is a 29-year-old woman who was diagnosed with high-grade
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`(WHO grade III) anaplastic oligodendroglioma (“high-grade brain glioma”).
`Plaintiff sought care and treatment at Mayo Clinic’s Proton Beam Program
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`(“Mayo”).
`In 2019 it was recommended by her treating physicians at the Mayo Clinic
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`that Plaintiff be treated with PBRT.
`Plaintiff’s doctors determined that PBRT was the best course of treatment
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`for Plaintiff.
`Plaintiff’s doctors concluded that PBRT was medically necessary for
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`Plaintiff because PBRT, as opposed to Intensity-Modulated radiation therapy (IMRT),
`greatly reduces the risk of creating a radiation-induced malignancy in her brain.
`49. Rebecca initiated a pre-service claims and appeals process in July 2019
`and a post-service claims process in February 2020.
`50. On July 18, 2019, Aetna denied Rebecca’s pre-service claims for PBRT on
`the grounds that: “We [Aetna] used the Clinical Policy Bulletin (CPB): Proton Beam and
`Neutron Beam Radiotherapy. Based on CPB criteria information we have, we are
`denying coverage for proton beam radiotherapy. Medical studies have not proven that
`this procedure is effective for treatment of your condition.”
`51. On July 25, 2019, Aetna denied Rebecca’s first level pre-service appeal for
`PBRT on the grounds that: “We used the Clinical Policy Bulletin (CPB): Proton Beam
`and Neutron Beam Radiotherapy. Based on CPB criteria and the information we have,
`we are denying coverage for proton beam radiotherapy. Medical studies have not proven
`that this procedure is effective for treatment of your condition. This decision was made
`utilizing the Aetna CPB referenced above.”
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`COMPLAINT
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`Northridge, California 91324
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`19839 Nordhoff Street
`KANTOR & KANTOR LLP
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`(818) 886 2525
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`Case 2:21-cv-01422-MTL Document 1 Filed 08/17/21 Page 7 of 17
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`52. On February 27, 2020, Aetna denied Plaintiff’s post-service claims for
`PBRT between September 3, 2019 and September 30, 2019.
`53. On October 26, 2020, Aetna denied Plaintiff’s first level post-service
`appeal for “the billed amount of the claim [which] is $100,104.00” on the grounds that:
`Clinical studies have not proven this procedure to be an effective treatment
`for her condition. Our review found that she had a diagnosis of
`oligodendroglioma. Per the criteria listed above, Banner Aetna considers
`proton beam
`radiotherapy
`experimental
`and
`investigational
`for
`oligodendroglioma in adults (over age 21) because its effectiveness for this
`indication has not been established. Therefore, criteria are not met, and the
`previous denial of coverage on procedure code 77523 is upheld.
`54. Aetna also appears to conclude that PBRT is experimental and/or
`investigational for Rebecca’s diagnosis per its Clinical Policy (“CPB”) Proton Beam and
`Neutron Beam Radiotherapy (Aetna’s “Medical Policy”).
`In all pre-service and post-service appeals, Plaintiff and her treating
`55.
`providers submitted extensive medical literature and analysis showing that proton
`therapy results in superior outcomes and reduced long-term side effects as compared
`with IMRT for her diagnosis.
`56. Dr. Sujay A. Vora’s and Plaintiff’s appeal submissions to Aetna make clear
`that the medical community has found that in Plaintiff’s case PBRT is both medically
`necessary and a superior form of treatment, citing to numerous sources of established
`peer-reviewed literature proving this claim.
`57. For example, Dr. Vora’s appeal submission on Plaintiff’s behalf to Aetna
`states that PBRT is both medically necessary and a superior form of treatment for high-
`grade brain gliomas over IMRT:
`In Ms. Bartee’s case, my recommendation would be in favor of proton
`therapy over photon therapy using IMRT. 1) Proton therapy will provide
`meaningful improvement in neurocognition, short term memory due to
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`COMPLAINT
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`Northridge, California 91324
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`19839 Nordhoff Street
`KANTOR & KANTOR LLP
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`(818) 886 2525
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`Case 2:21-cv-01422-MTL Document 1 Filed 08/17/21 Page 8 of 17
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`hippocampal sparing 2) Proton therapy will reduce the risk for secondary
`malignancies.
`In summary, Plaintiff’s pre-service and post-service appeals to Aetna
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`contained citations to and physical copies of at least nine peer-reviewed scientific
`studies, published between 2010 and 2020, all conclusively finding PBRT to be both
`medically necessary and a superior form of treatment than established alternative
`treatments (like IMRT) for the treatment of high-grade gliomas.
`59. On December 21, 2020, Plaintiff submitted her second level post-service
`appeal to Aetna.
`60. As of January 25, 2021, Aetna reversed its decision to deny the treatment
`received by the Plaintiff, to the extent that the denial was predicated on the grounds that
`the treatment was either experimental or was not established as the appropriate treatment
`for her condition. While the claims submitted were for in excess of $100,000.00, the
`Aetna letter of January 25, 2021, (attached hereto as Exhibit “1”) only referenced claims
`for $84,924.00. The letter of January 25, 2021, agreed to process the claims pursuant to
`Plan terms.
`61. However, in the nearly seven months between the letter of January 25,
`2021, and the present, neither the provider of the treatment, or Plaintiff, or her counsel,
`have received any communication regarding the reprocessing of the claims, or the
`decision regarding such reprocessing. Pursuant to the applicable ERISA claims
`handling guidelines, Plaintiff’s claims are now deemed exhausted for purposes of any
`pre-litigation appeal obligations.
`Plaintiff has communicated with Mayo to determine if Aetna has released
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`any reimbursement relating to Plaintiff’s PBRT treatment to Mayo. To date, Mayo
`indicates that it has not received any reimbursement associated with Plaintiff’s PBRT
`treatment.
`Plaintiff has also not received any reimbursement from Aetna for her
`63.
`PBRT treatment at Mayo.
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`COMPLAINT
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`Northridge, California 91324
`
`19839 Nordhoff Street
`KANTOR & KANTOR LLP
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`(818) 886 2525
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`

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`Case 2:21-cv-01422-MTL Document 1 Filed 08/17/21 Page 9 of 17
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`Plaintiff has performed all duties and obligations on Plaintiff’s part to be
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`performed under the Plan. To the extent that other requirements were not fulfilled,
`Plaintiff was excused from performing the same because of the doctrines of exhaustion,
`deemed exhausted, and of futility.
`Relevant Plan Definitions
`Plaintiff sought coverage for PBRT under the Plan, which includes a list of
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`“Exclusions,” which are deemed to be services that are not covered under the Plan.
`66. One such Exclusion is for services deemed “Experimental or
`Investigational” (the “E/I Exclusion”), where “Experimental or Investigational” is
`defined as:
`A drug, device, procedure or treatment that we find is experimental or
`investigational because:
`• There is not enough outcome data available from controlled clinical trials
`published in the peer-reviewed literature to validate its safety and
`effectiveness for the illness or injury involved.
`• The needed approval by the FDA has not been given for marketing.
`• A national medical or dental society or regulatory agency has stated in
`writing that it is experimental or investigational or suitable mainly for
`research purposes.
`• It is the subject of a Phase I, Phase II or the experimental or research arm
`of a Phase III clinical trial. These terms have the meanings given by
`regulations and other official actions and publications of the FDA and
`Department of Health and Human Services.
`• Written protocols or a written consent form used by a facility provider
`state that it is experimental or investigational.
`• It is provided or performed in a special setting for research purposes.
`67. Radiation therapy is a procedure, and therefore, is not subject to FDA
`regulation.
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`COMPLAINT
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`Northridge, California 91324
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`19839 Nordhoff Street
`KANTOR & KANTOR LLP
`
`(818) 886 2525
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`

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`Case 2:21-cv-01422-MTL Document 1 Filed 08/17/21 Page 10 of 17
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`The accelerators and other equipment used to generate and deliver PBRT
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`are regulated by the FDA.
`69. On February 22, 1988, the FDA approved the Proton Therapy System, and
`designated it as a Class II Device for radiological treatment.
`This classification was codified at 21 C.F.R. § 892.5050 and describes the
`70.
`Proton Therapy System as a “device that produces by acceleration high energy charged
`particles (e.g., electrons and protons) intended for use in radiation therapy.”
`Thus, at least as of February 22, 1988, PBRT no longer fit within the E/I
`71.
`Exclusion to the Plan.
`PBRT has long been recognized as an established, medically appropriate
`72.
`treatment for the treatment of cancer, including high-grade brain gliomas.
`Plaintiff’s request for PBRT falls outside of the Plan’s exclusions for
`73.
`experimental or investigational services.
`74. Under FDA regulations, an institutional review board (IRB) is “an
`appropriately constituted group that has been formally designated to review and monitor
`biomedical research involving human subjects.” In accordance with FDA regulations, an
`IRB has the authority to approve, require modifications in (to secure approval), or
`disapprove research. This group review serves an important role in the protection of the
`rights and welfare of human research subjects.
`75. As published in the Federal Register on January 15, 2009, (74 FR 2358),
`21 CFR Part 56 (entitled “Institutional Review Boards”) was amended with regard to
`IRB registration (21 CFR 56.106). This amendment required that each IRB in the United
`States that reviews FDA-regulated studies to register. IRB registration information is
`entered into an Internet-based registration system maintained by the Department of
`Health and Human Services (HHS) and can be accessed at http://www.clinicaltrials.gov.
`76. Via this online registration system anyone is able to search all registered
`IRBs in the United States relating to PBRT regardless of whether it is currently active,
`completed, previously withdrawn, suspended or terminated, etc. A review of this
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`COMPLAINT
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`Northridge, California 91324
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`19839 Nordhoff Street
`KANTOR & KANTOR LLP
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`(818) 886 2525
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`

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`Case 2:21-cv-01422-MTL Document 1 Filed 08/17/21 Page 11 of 17
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`database of IRBs reveals 351 different IRBs that either are currently active or have been
`previously been completed or are no longer active. During the relevant time period, there
`were no active IRBs at Mayo or any other institution in the US studying the use of
`PBRT to treat anaplastic astrocytoma (high grade gliomas). Plaintiff’s request for PBRT
`was not subject to review and approval by an IRB during the relevant time period.
`77. At the time that Plaintiff made her request for PBRT and Aetna made its
`benefit determination, PBRT was not subject to any ongoing clinical trials.
`The prevailing published peer-reviewed medical literature that was
`78.
`submitted to Aetna in support of Plaintiff’s request for PBRT demonstrated that PBRT is
`not an experimental or investigational treatment as defined in the Plan.
`For example, one of the studies submitted as part of Plaintiff’s appeal
`79.
`submission to Aetna was a 2017 study clearly concludes that: “Treatment planning
`studies have been performed to compare the target coverage, dose homogeneity and
`OAR [organ-at-risk] sparing using IMRT, VMAT and IMPT in patients with gliomas,
`with overall similar target coverage. The target homogeneity was found improved for
`VMAT and even more for IMPT as compared with IMRT. As expected, a significant
`sparing of the OAR can be obtained using IMPT.” (emphasis added; citation omitted)
`Two other cohort studies submitted by Plaintiff to Aetna concluded that
`80.
`“Patients with oligodendroglioma but not astrocytoma develop PsP earlier after protons
`compared to photons. PsP was associated with better PFS [progression free survival
`rate].” (citation omitted). Another 2018 study concluded that “PBT is associated with
`improved OS [overall survival] compared to XRT [IMRT] for patients with gliomas.”
`(citation omitted).
`The Plan contains an exclusion for services that are not “Medically
`81.
`Necessary” where the Plan defines “Medically Necessary” as follows:
`Health care services that a provider exercising prudent clinical judgment, would
`provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an
`illness, injury, disease or its symptoms, and that are:
`
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`11
`COMPLAINT
`
`Northridge, California 91324
`
`19839 Nordhoff Street
`KANTOR & KANTOR LLP
`
`(818) 886 2525
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`

`

`Case 2:21-cv-01422-MTL Document 1 Filed 08/17/21 Page 12 of 17
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`In accordance with generally accepted standards of medical practice.
`•
`Clinically appropriate, in terms of type, frequency, extent, site and
`•
`duration, and considered effective for the patient's illness, injury or disease.
`Not primarily for the convenience of the patient, physician, or other health
`•
`care provider.
`Not more costly than an alternative service or sequence of services at least
`•
`as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or
`treatment of that patient's illness, injury or disease.
`•
`“Generally accepted standards of medical practice” means “Standards that
`are based on credible scientific evidence published in peer-reviewed medical literature
`generally recognized by the relevant medical community.”
`Proton therapy for high grade gliomas is medically necessary and is not
`82.
`excluded under the exclusion for services that are not medically necessary.
`The rationales articulated by Aetna in its pre-service and post-service
`83.
`appeal denials of Plaintiff’s claims for PBRT amount to the following: “Medical studies
`have not proven that this procedure is effective for treatment of your condition.”
`84.
`This rationale plainly ignores the overwhelming peer-reviewed medical
`literature that concludes that PBRT is safe, effective, and a superior form of
`treatment for high-grade brain gliomas.
`Aetna’s PBRT Clinical Policy
`85. Aetna drafted and implemented the PBRT Clinical Policy Bulletin, which
`at the time Aetna applied it to Plaintiff’s requests for PBRT was most recently reviewed
`on March 14, 2019.
`86. Aetna’s PBRT Clinical Policy Bulletin was based on outdated medical
`evidence and ignored accepted medical peer-reviewed evidence that PBRT is safe and
`effective for the treatment of cancer.
`The unreasonableness of the PBRT Clinical Policy is illustrated by the fact
`87.
`that Aetna considers PBRT “experimental and investigational” for most types of
`
`
`12
`COMPLAINT
`
`Northridge, California 91324
`
`19839 Nordhoff Street
`KANTOR & KANTOR LLP
`
`(818) 886 2525
`
`

`

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`Case 2:21-cv-01422-MTL Document 1 Filed 08/17/21 Page 13 of 17
`
`cancers, including high-grade brain gliomas, in “adults (over age 21) . . . because its
`effectiveness for these indications has not been established” while on the other hand
`Aetna considers PBRT “medically necessary” to treat all “[m]alignancies in children (21
`years of age and younger),” as well as certain listed types of tumors.
`88. Aetna’s PBRT Clinical Policy Bulletin does not consider PBRT
`“experimental and investigational” when treating children (21 years of age and younger)
`and approves PBRT for these patients.
`There are no medical studies that support a conclusion that PBRT would
`89.
`be a proven, safe, and effective treatment for the same cancer in one age group but not
`the other.
`90. Aetna employs the PBRT Clinical Policy Bulletin as part of its prior
`authorization review and adjudication of members and beneficiaries’ claims to deny
`claims for coverage of PBRT as “experimental or investigational” or not “medically
`necessary” without ever engaging in any reasonable review of clinical records prior to
`rendering the determination of coverage.
`91. Aetna drafts, adopts, and implements its PBRT Clinical Policy Bulletin—
`as it did here with respect to Plaintiff’s requests and claims for PBRT—by relying upon
`outdated medical evidence, by ignoring contemporary medical evidence, and by taking a
`coverage position that plainly contradicts the standard of care in the medical community.
`92. Aetna’s application of its PBRT Clinical Policy Bulletin to Plaintiff’s
`requests and claims for PBRT is an improper substitute to Aetna’s legal obligation to
`conduct an adequate, full, and fair review of member-submitted clinical records like
`Plaintiff’s.
`93. Aetna did not provide Plaintiff with a full and fair review of her clinical
`records by appropriate medical directors (who have experience or training in the context
`of radiation oncology or who are board certified in the requisite medical specialty) prior
`to rendering its coverage determinations.
`
`
`
`
`
`13
`COMPLAINT
`
`Northridge, California 91324
`
`19839 Nordhoff Street
`KANTOR & KANTOR LLP
`
`(818) 886 2525
`
`

`

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`Case 2:21-cv-01422-MTL Document 1 Filed 08/17/21 Page 14 of 17
`
`It is readily apparent that at no point during the claims and appeals
`94.
`processes that Aetna’s medical reviewers considered any of the factors specific to
`Plaintiff’s diagnosis but rather applied its blanket policy of denying proton therapy for
`high grade gliomas.
`It is also apparent that Aetna never addressed how its PBRT Clinical
`95.
`Policy Bulletin, with its outdated references, could possibly have reasonably provided a
`fair snapshot of whether PBRT was considered experimental/investigational in 2019 and
`2020, which is the relevant time period related to Plaintiff’s requests for PBRT.
`96. Aetna’s reliance on its PBRT Clinical Policy Bulletin is merely a way for
`Aetna to categorically deny prior authorization requests and claims for
`reimbursement for PBRT to treat most cancers, including high-grade brain gliomas.
`FIRST CAUSE OF ACTION
`FOR DENIAL OF PLAN BENEFITS UNDER ERISA
`Plaintiff incorporates by reference the foregoing paragraphs as though
`97.
`fully set forth herein.
`Plaintiff was covered under the Plan at all relevant times.
`98.
`99.
`Plaintiff’s requested and performed treatment was covered under this
`group policy as it was medically necessary, constituted appropriate medical treatment,
`and was not experimental, investigational, or unproven.
`100. Defendant wrongfully denied Plaintiff’s claim for PBRT in the following
`respects:
`(a) Wrongfully concluding PBRT was excluded as experimental or
`investigational, or not medically necessary, when in fact PBRT is a mainstream
`treatment which has been performed by reputable physicians for decades;
`Failure to provide prompt and reasonable explanations of the bases relied
`(b)
`on under the terms of the plan documents, in relation to the applicable facts and plan
`provisions, for the denial of Plaintiff’s requests;
`
`
`
`
`
`14
`COMPLAINT
`
`Northridge, California 91324
`
`19839 Nordhoff Street
`KANTOR & KANTOR LLP
`
`(818) 886 2525
`
`

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`Case 2:21-cv-01422-MTL Document 1 Filed 08/17/21 Page 15 of 17
`
`(c) After Plaintiff’s claims were denied in whole or in part, failure to
`adequately describe to Plaintiff any additional material or information necessary for
`Plaintiff to perfect her claim along with an explanation of why such material is or was
`necessary;
`Failure to properly and adequately investigate the merits of Plaintiff’s
`(d)
`request and/or consider the information provided by Plaintiff;
`Failure to consider the overwhelming medical evidence which showed that
`(e)
`the requested treatment was medically necessary, safe, effective, and not investigational;
`and
`
`Once having reversed its original basis of denial, failed to timely process
`(f)
`the claims under the terms of the Plan.
`101. Plaintiff is prepared to amend to allege that, if she confirms in discovery,
`Defendant wrongfully denied the claim for benefits by other acts or omissions.
`102. Following the denial of the claims for benefits under the Plan, Plaintiff
`exhausted all administrative remedies required under ERISA, or was excused from
`doing so due to Defendant’s conduct, and performed all duties and obligations on her
`part to be performed.
`103. As a proximate result of the denial of benefits due Plaintiff, Plaintiff has
`been irreparably damaged.
`104. Plaintiff has been denied medically necessary treatment and left with a
`substantial sum of money to be paid by him out-of-pocket.
`105. As a further direct and proximate result of this improper determination
`regarding the medical claims, Plaintiff, in pursuing this action, has been required to
`incur attorneys’ costs and fees.
`106. Pursuant to 29 U.S.C. § 1132(g)(1), Plaintiff is entitled to have such
`attorneys’ fees and costs paid by Defendant.
`
`
`
`
`
`15
`COMPLAINT
`
`Northridge, California 91324
`
`19839 Nordhoff Street
`KANTOR & KANTOR LLP
`
`(818) 886 2525
`
`

`

`Case 2:21-cv-01422-MTL Document 1 Filed 08/17/21 Page 16 of 17
`
`107. Due to the wrongful conduct of Defendant, Plaintiff is entitled to enforce
`her rights under the terms of the Plan and to clarify her rights to future benefits under the
`terms of the Plan.
`
`SECOND CAUSE OF ACTION
`FOR EQUITABLE RELIEF
`Plaintiff incorporates by reference the foregoing paragraphs as though
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`fully set forth herein.
`As a direct and proximate result of the failure of the Defendant to pay
`109.
`claims fo