ERISA: Claims Administrator acted legally but perhaps not morally in denying preapproval of stem cell transplant for systemic sclerosis pursuant to Plan’s experimental/investigational exclusion despite claim by doctors that it is medically necessary to prevent death… Molloy.
Lana Robertson seeks a declaration that a medical procedure is covered by her health benefits plan. At issue is the tension posed by the human person who is facing certain death absent the treatment, and an ERISA plan and administrator that resort to legalisms supported in some sense by the idea of the rule of law to deny her a chance at life. Sadly, in this and so many other cases decided pursuant to a law intended to protect employees, there seems to be little concern about the moral consequences of denial of benefits. The decision by the plan administrator is akin to the “death panels” ostracized for political purposes. Yet the legalistic arguments and the law seem to dictate an untenable moral determination. Judge Noonan of this Circuit noted aptly in Persons and Masks of the Law, “Abandonment of the rules produces monsters; so does the neglect of persons.” To paraphrase him, at the intersection of the conflict between rules and persons, the process of the rule of law is to be understood. “A chief difficulty to understanding, however, is the presence of masks, formed by rules and concealing the person.” The legal reasoning justifying resolution of the pending motions is monstrous in its concealing the likely life-ending consequences of applying rules and ignoring the person. However, for the reasons stated below, which sound in the legal rules of interpretation and not in equity, Robertson’s motion is denied and Defendants’ motions are granted.
Stallion Oilfield Holdings is Plan Sponsor and Plan Administrator. BCBS of Texas is Claims Administrator and Claims Fiduciary. It is a division of Health Care Service Corp. Robertson is enrolled in the Select Plan Managed Care Program. She was diagnosed in 7/11 with diffuse systemic sclerosis. Without treatment it can attack internal organs and is fatal once it infiltrates the lungs or heart. She initially received drug-oriented treatment under the Plan, which was ineffective. Richard Burt of Feinberg School of Medicine recommended a hemapoietic stem cell transplant. BCBS denied preapproval, concluding that it is “experimental, investigational, and unproven,” referencing HCS’s Medical Policy. An independent review upheld the denial, again referencing HCS’s Medical Policy. Robertson submitted her final appeal in 2/14 with more than 300 pages of medical records and articles and physician letters. A different review organization again affirmed the denial. Robertson sued Stallion and BCBS seeking a declaration that the Plan covers the procedure.
Robertson claims that a violation of ERISA procedural requirements requires a de novo review and that BCBS “did just that” by failing to engage in a medical necessity analysis and by withholding the information it relied on in making its determination. Only “when an administrator engages in wholesale and flagrant violations of the procedural requirements of ERISA, and thus acts in utter disregard of the underlying purpose of the plan,” will the denial be reviewed de novo. Abatie (9th Cir. 2006, en banc). There is no proof that BCBS engaged in “wholesale and flagrant violations.” Robertson also argues that an inherent conflict of interest that affects a determination alters the standard of review and that BCBS had such a conflict because of its pecuniary interest and its interest in establishing precedent for future denials for the procedure. BCBS does not fund the plan, and Robertson has produced no evidence demonstrating that it, as a division of HCS, had a vested pecuniary interest in denying coverage or that it sought to establish precedent for future denials. Not only does the abuse of discretion standard apply, there is no conflict of interest to be weighed in determining whether BCBS abused its discretion.
Robertson insists that the clinical trial exclusion does not apply to the procedure. The provision that “treatment provided as part of a clinical trial or a research study is “Experimental/Investigational” is unambiguous. There is no question that Robertson sought to enroll in a phase 3 clinical trial, which is described as a “study” that will provide treatment to the participants in both the “control” and “experimental” arms of the program. BCBS arguably construed the exclusion in a legally reasonable way. Moreover, Burt acknowledged that the procedure is not “standard therapy” for severe systemic sclerosis. The literature Robertson submitted shows that it is still under investigation and is associated with treatment-related mortality, but is not “in general use in the medical community.” Robertson claims that the clinical trial is not testing whether the procedure is safe & effective, but whether a less intense regimen is safer and as effective as the standard regimen. Although this argument may have merit, she cites no authority or Plan provision supporting her restricted definition of “clinical trial,” while the clinical trial exclusion broadly excludes “treatment provided as a part of a clinical trial.” BCBS also relied on the HCS Medical Policy in denying coverage. Robertson claims that the HCS guidelines have not been peer-reviewed or incorporated into the Plan documents, and that it demonstrates that the procedure is more effective than drug therapy, which has been ineffective. The Policy provision states that the Plan documents govern, and a claim “stands or falls by the terms of the plan.” Kennedy(US 2009). Where BCBS reasonably relied on the Plan’s clinical trial exclusion, its additional reliance on the Medical Policy is of no consequence regardless of whether it supports coverage. BCBS did not abuse its discretion in relying on the clinical trial exclusion to deny benefits.
Robertson insists that BCBS abused its discretion by not making a medical necessity determination, which would “trump” the experimental/investigational exclusion. However, the Plan unambiguously states that benefits are not available for experimental/investigative services. To interpret it to cover all medically necessary treatments regardless of any exclusions or limitations would render those exclusions meaningless. Johnson(4th Cir. 2013).
Robertson also maintains that the exclusion is unenforceable under the reasonable expectations doctrine. While she may reasonably expect coverage for any treatment that is medically necessary, the experimental/investigational exclusion is plain, conspicuous, and enforceable. Winters (9th Cir. 1995).
Robertson included in her final appeal 4 instances where BCBS entities approved the same procedure because it was medically necessary despite a prior determination that it was experimental/investigational. One of those involves BCBS of Illinois, which is also a division of HCS. Although it is disconcerting that BCBS entities may be making inconsistent determinations, the Plan language under which those determinations were made are not part of the record and cannot be used in analyzing this case.
Robertson’s medical condition cannot be conflated with her legal condition so that the Court is “left with a definite and firm conviction that a mistake has been committed.” Salomaa (9th Cir. 2011). BCBS acted legally in denying preapproval of the procedure because her enrollment in the clinical trial is excluded as experimental/investigational under terms of the Plan.
Robertson v. BCBS of Texas and Stallion Oilfield Holdings, 42 MFR 443, 4/15/15.
Donald Harris (Harris & Associates), Billings, and Tucker Gannett (Harris & Warren), Billings, for Robertson; Stanley Kaleczyc, Daniel Auerbach, and Kimberly Beatty (Browning, Kaleczyc, Berry & Hoven), Helena, and Rebecca Hanson (Foley & Lardner), Chicago, for BCBS; Shane Coleman & Michael Manning (Holland & Hart), Billings, and Michael Beaver (Holland & Hart), Greenwood Village, Colo., for Stallion.