Case 1:21-cv-12107 Document 1 Filed 12/21/21 Page 1 of 11
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`UNITED STATES DISTRICT COURT
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`DISTRICT OF MASSACHUSETTS
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`Plaintiff
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`V.
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`R.M.,
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`ANTHEM BLUE CROSS AND BLUE
`SHIELD, THE CAPITAL ONE FINANCIAL
`CORPORATION EMPLOYEE BENEFITS
`PLAN, AND CAPITAL ONE FINANCIAL
`CORPORATION
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`CIVIL ACTION NO.
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`Defendants
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`COMPLAINT
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`INTRODUCTION
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`1. Plaintiff, R.M. brings this action against the Defendants, Anthem Blue Cross and Blue
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`Shield (“Anthem”), The Capital One Financial Corporation Employee Welfare Benefits
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`Plan (“the Plan”), and Capital One Financial Corporation (“Capital One”) (collectively
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`referred to as “Defendants”) for violations of the Employee Retirement Income Security
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`Act of 1974, as amended, 29 U.S.C. §§ 1001 et. seq. (“ERISA”). R.M., a minor, was a
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`beneficiary of an ERISA welfare benefit plan administered by Anthem and insured by
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`Capital One.
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`2. Plaintiff challenges Defendants’: 1) unreasonable and unlawful denial of R.M.’s claim for
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`vertebral body tethering (“VBT”) surgery to treat scoliosis despite substantial medical
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`evidence demonstrating R.M.’s entitlement to said benefits; 2) pattern of rejecting and/or
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`Case 1:21-cv-12107 Document 1 Filed 12/21/21 Page 2 of 11
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`ignoring the substantial evidence supporting R.M.’s entitlement to coverage; 3) failure to
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`provide R.M. with a full and fair review of her claim; and 4) failure to provide a
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`reasonable claims procedure that would yield a decision on the merits of R.M.’s claim.
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`JURISDICTION
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`3. This Court has personal and subject matter jurisdiction over this case under 29 U.S.C. §
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`1132(e) and (f), without regard to jurisdictional amount or diversity of citizenship, in that
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`the Defendants’ breach of their ERISA obligations took place in this district.
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`PARTIES
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`4. The plaintiff, R.M., presently resides in Tyngsboro, Massachusetts. At the time the
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`treatment began which is the subject of this Complaint, R.M. was, and continues to be, a
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`minor dependent beneficiary of a participant in the Plan, within the meaning of 29 U.S.C.
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`§ 1002(2)(7). R.M. has standing to bring this action under 29 U.S.C. § 1132(a).
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`5. The Defendant, Anthem, is a for-profit corporation, with its principal place of business at
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`220 Virginia Avenue, Indianapolis, IN 46204. Anthem was responsible for administering
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`claims under the Plan and making decisions regarding Plan participants’ eligibility for
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`benefits.
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`6. The Defendant, the Plan, is an “employee welfare benefit plan” as defined by ERISA, 29
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`U.S.C. §1002(1).
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`7. The Defendant, Capital One, is a for-profit corporation, with its principal place of
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`business at 1680 Capital One Drive McLean, VA 22102. Capital One is responsible for
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`insuring claims made under the Plan.
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`Case 1:21-cv-12107 Document 1 Filed 12/21/21 Page 3 of 11
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`8. At all times relevant to the claims asserted in this Complaint, Anthem and Capital One
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`purported to act as an ERISA claims fiduciaries with respect to participants of the Plan
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`generally, and specifically with respect to R.M., within the meaning of ERISA.
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`The Plan.
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`FACTS
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`9. As a dependent of a Plan employee, R.M. was entitled to health insurance coverage under
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`the Plan.
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`10. For R.M.’s VBT to be a covered benefit under the Plan, it must be Medically Necessary,
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`defined in the Plan as:
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`• A service or supply furnished by a particular provider is necessary if
`Anthem determines that it is appropriate for the diagnosis, care or
`treatment of the disease or injury involved.
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`To be appropriate, the service or supply must:
`• Be care or treatment as likely to produce a significant positive
`outcome, and no more likely to produce a negative outcome, than any
`alternative service or supply, both as to the disease or injury involved
`and the person’s overall health condition;
`• Be a diagnostic procedure, indicated by the health status of the person
`and be as likely to result in information that could affect the course of
`treatment as, and no more likely to produce a negative outcome than,
`any alternative service or supply, both as to the disease or injury
`involved and the person’s overall health condition; and
`• As to diagnosis, care and treatment be no more costly (taking into
`account all health expenses incurred in connection with the service or
`supply) than any alternative service or supply to meet the above tests.
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`11. The Plan excludes treatment it determines to be Experimental or Investigational from
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`coverage, defined in the Plan as the following:
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`Care is considered experimental or investigational if:
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`• There are insufficient outcomes data available from controlled
`clinical trials published in the peer reviewed literature to substantiate
`its safety and effectiveness for the illness or injury involved; or
`It does not have a required approval for marketing by the U.S. Food
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`•
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`Case 1:21-cv-12107 Document 1 Filed 12/21/21 Page 4 of 11
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`•
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`and Drug Administration; or
`• A nationally-recognized medical or dental society or regulatory
`agency has determined,
`in writing,
`that
`it
`is experimental,
`investigational or for research purposes; or
`It is a type of drug, device or treatment that is the subject of a Phase 1
`or Phase II clinical trial or the experimental or research arm of a
`Phase III clinical trial, using the definition of “phases” indicated in
`regulations and other official actions and publications of the FDA and
`Department of Health and Human Services; or
`• The written protocol(s) or written informed consent used by the
`treating facility—or another facility studying the same drug, device,
`treatment or procedure—states that it is experimental, investigational
`or for research purposes.
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`12. To determine whether the requested treatment is Medically Necessary, Anthem applied
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`its Vertebral Body Stapling and Tethering for the Treatment of Scoliosis in Children and
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`Adolescents Coverage Guidelines, which state:
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`Vertebral body stapling and vertebral body tethering as treatment of
`scoliosis in children and adolescents are considered investigational and not
`medically necessary.
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`R.M.’s Claim for VBT and Anthem’s Response.
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`13. R.M. suffers from severe progressive scoliosis, for which “surgical intervention was
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`clearly indicated” as described by her treating surgeon Dr. Amer Samdani.
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`14. R.M.’s treating providers recommended she pursue VBT as traditional surgical
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`intervention (spinal fusion) would drastically limit her spinal motion and over time lead
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`to worse outcomes including degenerative disease of her spine, pain, and limited motion.
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`15. The VBT tethering device was approved by the Food and Drug Administration (“FDA”)
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`on August 16, 2019.
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`16. On March 4, 2020, Anthem denied R.M.’s claim for VBT as Investigational, based on
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`Anthem’s determination “[t]his procedure is not approvable under the plan clinical
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`criteria because there is no proof or not enough proof that it improves health.”
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`17. In making this determination, Anthem relied on its VBT Medical Policy.
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`18. On March 13, 2020, R.M.’s mother requested an expedited appeal of Anthem’s denial,
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`submitting a treatment narrative, peer reviewed article, and article regarding the FDA’s
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`approval of VBT.
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`19. On March 19, 2020, and again on April 19, 2020, Anthem upheld its decision to deny
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`R.M.’s claim for VBT.
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`20. On May 4, 2020, R.M. submitted a request for her complete claim file to Anthem.
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`21. On May 15, 2020, R.M. timely submitted her second level appeal to Anthem.
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`22. Follow-up requests for R.M.’s claim file were forwarded to Anthem on May 14, 2020,
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`June 3, 2020, June 17, 2020, July 1, 2020, July 24, 2020.
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`23. On July 29, 2020, Anthem provided R.M. with an incomplete copy of her claim file, 86
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`days after her initial request.
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`24. After multiple follow-up requests for the missing documentation in R.M.’s claim file,
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`Anthem provided additional information to R.M. on August 21, 2020, September 1, 2020,
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`and September 14, 2020. Each disclosure was incomplete.
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`25. On July 4, 2020, R.M. received an explanation of benefits (“EOB”) from Anthem
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`denying her claim for her surgical stay due to lack of prior authorization, even though the
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`prior authorization request was submitted, and denied by Anthem on March 4, 2020 and
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`was appealed by R.M. on May 15, 2020.
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`26. On September 1, 2020, R.M. timely filed her appeal of the July 4, 2020 EOB denial.
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`27. On October 30, 2020, R.M. supplemented her appeals with her complete medical and
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`surgical records from two hospitals, two treatment narratives from her treating and
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`examining surgeons, an affidavit from her mother, and peer reviewed literature on the
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`efficacy of VBT.
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`28. On November 6, 2020, R.M. requested the opportunity to respond to any medical reviews
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`conducted on appeal prior to Anthem’s conclusion of the internal appeals process.
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`29. R.M. submitted follow up requests for Anthem’s medical reviews on November 23, 2020,
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`December 14, 2020, and December 22, 2020.
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`30. On December 22, 2020, without providing R.M. the opportunity to review and respond to
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`Anthem’s medical reviews, Anthem upheld its denial of coverage.
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`31. Anthem’s refusal to provide R.M. with a copy its medical reviews conducted on appeal
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`constituted a violation of ERISA’s implementing regulations and First Circuit precedent.
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`See Jette v. United of Omaha Life Ins. Co., 18 F.4th 18 (1st Cir. 2021).
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`32. On May 7, 2021, R.M. submitted a request for reconsideration of Anthem’s decision to
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`Capital One.
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`33. On June 10, 2021, Capital One determined that R.M.’s claim was properly denied.
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`34. Neither Anthem nor any of the medical review opinions Anthem relied on addressed the
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`substance of R.M.’s treating surgeon and independent examining surgeon’s opinions
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`regarding the medical necessity of her VBT surgery, which contradicted Anthem’s
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`medical reviewers’ conclusions.
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`35. Neither Anthem nor any of the medical review opinions Anthem relied on addressed the
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`FDA approval of VBT, which contradicted Anthem’s medical reviewers’ conclusions
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`that the procedure is “investigational.,” pursuant to its own definition of the exclusion.
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`36. Neither Anthem nor any of the medical review opinions Anthem relied on spoke with her
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`treating or examining physicians, despite her surgeon’s repeated calls to Anthem and her
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`mother’s multiple attempts to schedule a discussion with Anthem’s physician.
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`37. None of the reviewers Anthem relied on to deny benefits examined R.M.
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`38. R.M. exhausted the internal appeals process provided by Anthem prior to filing suit.
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`Summary of Defendants’ Review of R.M.’s Claim.
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`39. R.M. has exhausted her administrative remedies pursuant to 29 C.F.R. 2560.503-1(1).
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`40. R.M.’s eligibility for benefits is based on the substantial evidence in Defendants’
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`possession.
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`41. The Defendants failed to respond to R.M.’s attempts to engage in a meaningful dialogue
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`regarding the evaluation of her claim.
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`42. Any discretion to which the Defendants may claim they are entitled under the Plan is
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`negated by their failure to provide R.M. with explanations as to their adverse decisions as
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`proscribed by ERISA and its implementing regulations.
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`43. The Defendants failed to meet the minimum requirements for the denial of R.M.’s
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`benefits, in violation of ERISA, 29 U.S.C. 1133, which requires that upon a denial of
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`benefits, the administrative review procedure must include adequate notice in writing
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`setting forth the specific reasons for the denial of benefits and a reasonable opportunity
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`for a full and fair review by the appropriate named fiduciary of the decision denying the
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`claim.
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`44. The Defendants have also failed to meet the Plan requirements for review of claims that
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`have been denied.
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`45. The Defendants failed to provide R.M. with a full and fair review of her claim for
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`benefits.
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`46. On appeal, Anthem’s physicians made no attempt to respond to or engage with R.M.’s
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`physician’s detailed treatment narratives addressing the elements of medical necessity, as
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`that term is defined by the Plan.
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`47. The decision to deny R.M. benefits was self-serving, wrongful, unreasonable, irrational,
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`solely contrary to the evidence, contrary to the terms of the Plan and contrary to law.
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`48. Due to the unlawful denials of benefits under ERISA, R.M. suffered significant financial
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`loss.
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`49. Having exhausted the administrative procedures provided by the Defendants, R.M. now
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`brings this action.
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`FIRST CAUSE OF ACTION
`(Enforcement of Terms of Plan
`Action for Unpaid Benefits)
`(ALL DEFENDANTS)
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`50. R.M. realleges each of the paragraphs above as if fully set forth herein.
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`51. The Plan is a contract.
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`52. R.M. performed all her obligations under the contract.
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`53. In particular, R.M. met all of the conditions for the payment of health insurance benefits
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`under Plan, including but not limited to, providing the Defendants proof of the medical
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`necessity of the requested treatment services, pursuant to the terms of her insurance
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`contract. Nonetheless, Defendants have failed to provide R.M. with the health insurance
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`benefits he is due under the terms of the Plan.
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`54. 29 U.S.C. § 1132(a)(1)(B) states that:
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`A civil action may be brought ---
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`Case 1:21-cv-12107 Document 1 Filed 12/21/21 Page 9 of 11
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`1.
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`by a participant or beneficiary –
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`1.
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`2.
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`for the relief provided for in subsection (c) of this section, or
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`to recover benefits due to her under the terms of her plan, to enforce
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`her rights under the terms of the plan, or to clarify her rights to future
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`benefits under the terms of the plan.
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`55. The Defendants’ actions constitute an unlawful denial of benefits under ERISA, as
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`provided in 29 U.S.C. §1132(a)(1)(B).
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`56. The Defendants unlawfully denied R.M.’s benefits in part by failing to provide R.M. with
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`a full and fair review of their decision to deny coverage for her claim for VBT.
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`57. In accordance with 29 U.S.C. §1132, R.M. is entitled to coverage for the medical care
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`R.M. received under the Plan based upon the medical necessity of this treatment.
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`58. The Defendants refused to provide R.M. with coverage for the covered medical services
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`received, and are, therefore, in breach of the terms of the Plan and ERISA, which requires
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`that the Defendants engage in a full and fair review of all claims and the administration of
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`the Plan in the best interests of the Plan participants.
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`59. R.M. is entitled to the Massachusetts twelve percent statutory rate of interest due to the
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`loss of the use of the funds expended to pay for R.M.’s medical necessity treatment.
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`SECOND CAUSE OF ACTION
`(Attorney’s Fees and Costs)
`(ALL DEFENDANTS)
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`60. R.M. realleges each of the paragraphs above as if fully set forth herein.
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`61. Under the standards applicable to ERISA, R.M. deserves to recover “a reasonable
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`attorney’s fee and costs of the action” herein, pursuant to section 502(g)(1) of ERISA, 29
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`U.S.C. § 1132(g).
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`Case 1:21-cv-12107 Document 1 Filed 12/21/21 Page 10 of 11
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`62. Defendants have the ability to satisfy the award.
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`63. R.M.’s conduct of this action is in the interests of all participants who subscribe to the
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`Plan, and the relief granted hereunder will benefit all such participants.
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`64. The Defendants have acted in bad faith in denying R.M.’s health insurance benefits under
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`the terms of the respective Plan.
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`65. The award of attorney’s fees against the Defendant will deter others acting under similar
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`circumstances.
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`PRAYER FOR RELIEF
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`WHEREFORE, the Plaintiff, R.M., requests this Court to:
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`(1)
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`(2)
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`Enter judgment for R.M. against Defendants;
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`Declare, adjudge, and decree that Defendants are obligated to pay R.M. the cost
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`of the disputed services;
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`(3)
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`Order that the Defendants make restitution to R.M. in the amount of all losses
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`sustained by R.M. as a result of the wrongful conduct alleged herein, together
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`with prejudgment interest;
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`(6)
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`(7)
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`Award twelve percent interest, costs, and attorneys’ fees to R.M.; and
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`Award such other relief as this Court deems just and proper .
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`Case 1:21-cv-12107 Document 1 Filed 12/21/21 Page 11 of 11
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`Date: December 21, 2021
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`Respectfully submitted,
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`R.M.
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`By her attorney,
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`/s/ Mala M. Rafik
`Mala M. Rafik
`BBO No. 638075
`ROSENFELD & RAFIK
`184 High Street, Suite 503
`Boston, MA 02110
`T: 617-723-7470
`F: 617-227-2843
`E: mmr@rosenfeld.com
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