Parsons v. Sisters of Charity of Leavenworth Health System, Inc.

832 F. Supp. 2d 1222, 2011 WL 2144894, 2011 U.S. Dist. LEXIS 57958
CourtDistrict Court, D. Montana
DecidedMay 31, 2011
DocketCause No. CV 10-47-BLG-RFC
StatusPublished

This text of 832 F. Supp. 2d 1222 (Parsons v. Sisters of Charity of Leavenworth Health System, Inc.) is published on Counsel Stack Legal Research, covering District Court, D. Montana primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Parsons v. Sisters of Charity of Leavenworth Health System, Inc., 832 F. Supp. 2d 1222, 2011 WL 2144894, 2011 U.S. Dist. LEXIS 57958 (D. Mont. 2011).

Opinion

ORDER GRANTING DEFENDANTS’ MOTIONS FOR SUMMARY JUDGMENT

RICHARD F. CEBULL, District Judge.

I. Introduction

Presently before the Court are Defendants Sisters of Charity of Leavenworth (“Sisters of Charity”) and Blue Cross Blue Shield of South Carolina and Blue Cross Blue Shield of Kansas City’s (“BCBS” collectively) motions for summary judgment. [1223]*1223Docs. 21 & 27. At the Court’s direction the Parties have supplemented their motions and responses with additional briefing regarding the application of Dr. Richard Burt’s deposition to the issues of the case. Doc. 67. Having reviewed and considered the briefing in this case, this Court is prepared to rule. Given that many of the Defendants’ summary judgment arguments overlap and all turn on the Defendants’ denial of coverage for Plaintiff Randee Parsons’s (“Parsons”) participation in a clinical trial for ABMT/stem-cell transplant treatment, they will be treated, for purposes of this Order, as a single motion for summary judgment.

II. Factual Background

Twenty year old Randee Parsons suffers from refractory Crohn’s disease, a severe autoimmune disease that inflames and attacks the victim’s gastrointestinal tract. Crohn’s disease is a chronic disease for which there is no known cure. Recently, treatment of Crohn’s disease with autologous bone marrow transplants (“ABMT”), a type of stem cell transplant treatment, has been shown to be partially successful. Dr. Richard Burt, an immunologist at Northwestern Medical School, has been conducting a clinical trial on treating Crohn’s disease with ABMT techniques. According to Plaintiffs, Dr. Burt’s ABMT trial was approved, at least in part, by the Food and Drug Administration as well as the National Institutes of Health.

In December 2009, Parsons sought and was granted admission into Dr. Burt’s clinical trial. Plaintiffs allege that other patients in Dr. Burt’s trial had received insurance coverage by their respective insurance companies. Parsons was covered by a Medical Plan issued to her mother through her employ at St. Vincent Healthcare Hospital, an affiliate of Defendant Sisters of Charity of Leavenworth Health System. Sisters of Charity’s employee medical plan is self-insured and does not contract with any health insurance company against risk of loss, but it does contract with third-party administrators Defendants BCBS South Carolina and BCBS Kansas City for administrative services.

Parsons sought coverage for the clinical trial through the Sisters of Charity Medical Plan, but was denied. Based on the review of application and the terms of the Plan, on February 2, 2010, BCBS sent Plaintiffs a letter denying coverage of the ABMT treatment on the grounds that Dr. Burt’s trial was “investigational and experimental” and not medically necessary.

Plaintiffs appealed BCBS’ denial to Sisters of Charity’s Benefit Administration Committee. As part of the appeals process, Sisters of Charity sought external independent review from gastroenterologists who had experience in Crohn’s disease. These reviewers concluded that only a limited number of Crohn’s patients had ever been treated with ABMT techniques and that Dr. Burt’s clinical trial was experimental and investigational and not medically necessary. In addition, this procedure was only available at “investigational centers of excellence under the overview of institutional research boards.”1 Ultimately, in a February 19, 2010 letter, the Benefits Administration Committee affirmed the denial of Plaintiffs’ requested benefits.

Plaintiffs appealed a second time. This time, Dr. James Koren, the Associate Medical Director for Defendant BCBS of South Carolina contacted Dr. Burt in order to initiate a peer-to-peer discussion regarding Dr. Burt’s research, as well as the ABMT procedure that he was seeking to perform on Parsons. Dr. Koren avers that during the conversation, Dr. Burt stated that other investigators in his field did not [1224]*1224recognize his research and that there was a controversy within the clinical community regarding the effectiveness of ABMT/ stem-cell transplant therapy for Crohn’s disease.2 Dr. Burt subsequently forwarded to Dr. Koren numerous abstracts and studies that Dr. Koren contends lead him to the conclusion that the ABMT procedure was still in the investigational and experimental stage.

In addition, on April 29 or 30th, Dr. Koren had a second conversation with Dr. Burt. Dr. Koren states that this second conversation was at Sisters of Charity’s request. It appears that no new information was gained from this conversation due to a deterioration in the cordial relationship of both participants.3

The relevant language in Sisters of Charity’s Medical Plan makes clear that:

REGARDLESS OF LANGUAGE CONTAINED ELSEWHERE IN THIS PLAN OF BENEFITS, THE FOLLOWING ARE NOT BENEFITS UNDER THE PLAN OF BENEFITS ... BCBS WILL NOT PAY ANY AMOUNT FOR THE FOLLOWING ... 1. Services and supplies that are not medically necessary as determined by the Plan Administrator ... 5. Services, supplies or drugs that are Experimental and Investigational .. ,4

The Plan defines “experimental and investigational” as,

Surgical procedures or medical procedures, supplies, devices or drugs which, at the time provided or sought to be provided, are in the judgment of BCBS not recognized as conforming to generally accepted medical practice, or the procedure, drug or device:
• Had not received final approval to market from appropriate government bodies; or,
• Is one about which the peer-reviewed medical literature does not permit conclusions concerning its effect on health outcomes; or,
• Is not demonstrated to be as established alternatives; or,
• Has not been demonstrated to improve net health outcomes; or,
• Is one in which the improvement claimed is not demonstrated to be obtainable outside the Experimental and Investigational settings.5

The Court notes that the criteria for “experimental and investigational” are stated in the disjunctive.

The Plan defines “medically necessary/medical necessity” as,

Benefits determined by BCBS (in the exercise of its discretion) to be:
• Required to identify or treat an illness or injury; and,
• Prescribed or ordered by a physician; and,
• Consistent with the diagnosis and treatment of the Covered Member’s condition; and,
• In accordance with the standards of good medical practice; and,
• Delivered in the most cost-effective setting; and,
• Required for reasons other than convenience of the Covered Member or the Covered Member’s Physician; and
• not to be services, supplies or drugs that are Experimental or Investigational.6

[1225]

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Cite This Page — Counsel Stack

Bluebook (online)
832 F. Supp. 2d 1222, 2011 WL 2144894, 2011 U.S. Dist. LEXIS 57958, Counsel Stack Legal Research, https://law.counselstack.com/opinion/parsons-v-sisters-of-charity-of-leavenworth-health-system-inc-mtd-2011.